4 jobs found in Basel, Basel-Stadt

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    • basel, basel-stadt
    • contract
    Randstad Professionals is looking for an Associate Director, Signal Management for a major client. This position will be based in Basel .Startdate: ASAP (up to 3 month notice period possible)Contract: 12 monthsThis position will have a high degree of visibility and impact across the organization and will collaborate closely cross-functionally and cross-regionally. Your responsibilities:Provide dynamic strategic contribution to the direction and senior leaders of key pharmacovigilance activities across portfolio and throughout the clinical development and post-marketing phases of the life cycle including: Lead all signal management activities for assigned product(s)  Support implantation of signal detection strategy approved by VP of Pharmacovigilance  Review adverse event data, literature and other safety-related data for the purpose of signal detection  Collaborate with Clinical Safety and Risk Management (CSRM) physicians, safety scientists, and medical colleagues to review safety data for signal validation, prioritization, assessment and proposed action plans Partner with the Director, Pharmacovigilance – Signal Management to oversee digital signal detection and management tool.  Serve as an administrator of the tool  Propose and implement signal detection methods in the tool  Train, mentor and assist CSRM staff in using the tool.  Oversee signal tracking and signal notifications to external stakeholders  Generate periodic signal management compliance metrics Provide safety contents for risk management plans and periodic aggregate safety reports, including but not limited to PBRER/PSUR, PADER, DSUR, and IND annual reports in collaboration with Clinical Safety and Risk Management (CSRM) physicians, safety scientists, and medical colleagues Assess document requirements, gauge document complexity, and identify information gaps or other potential issues. In collaboration with the relevant project team, the author proposes or contributes to strategies to resolve any identified issues  Reviews applicable regulatory intelligence on global regulations/guidance documents and be able to advise report project teams as a Subject Matter Expert (SME) for signal management.  Understand relationships and dependencies between signal management and documents/analyses produced for regulators across the development of RMPs, DSURs, PBRERs, and other annual reports and/or deliverables  Provide project teams with expertise on regulatory requirements and corporate policies governing documents for regulatory submission  Provide project teams with expertise and strategic guidance on analysis and presentation of safety data and on benefit-risk assessment in documents  Produce high quality, accurate, and fit-for-purpose evaluation documents with clear conclusions, in response to internal or regulatory authority request for safety reasons  Review the worldwide medical/scientific literature to identify signals and applicable information for inclusion in aggregate safety reports in collaboration with CSRM colleagues  Draft regulatory response documents such as PRAC assessment reports  Draft other medical writing deliverables as needed If you are interested to take on these responsibilities you should have the following requirements:Degree in Pharmacy, Nursing, Epidemiology, Biosciences or equivalent healthcare degree with pharmaceutical industry background  Minimum 8 years relevant medical, scientific/clinical, or pharmaceutical experience, including at least 5 years’ experience in Pharmacovigilance  Excellent written and verbal communication skills with the ability to interpret and present safety data  Knowledge of FDA and EMA regulations, ICH guidelines, Good Clinical Practices, and the drug development process  Knowledge of drug safety/pharmacovigilance practices and tools  Ability to coordinate and prioritize multiple projects in a fast-paced environment with limited to little supervision  Background in vaccines is a plus  Demonstrated ability to develop, execute and follow-through complex projects to completion  Skilled at working effectively in a collaborative team environment where results are achieved through influence and the incorporation of multiple points of view  Independently motivated, detail oriented and strong problem-solving ability  Excellent organizational skills and demonstrated ability to multitask in a fast-paced environment with changing priorities  Excellent written and verbal communication skills with the ability to interact across multiple functions Did we spark your interest? We look forward to receiving your online application. Please note a Swiss Work permit is mandatory and your residence needs to be in Switzerland for this position. 
    Randstad Professionals is looking for an Associate Director, Signal Management for a major client. This position will be based in Basel .Startdate: ASAP (up to 3 month notice period possible)Contract: 12 monthsThis position will have a high degree of visibility and impact across the organization and will collaborate closely cross-functionally and cross-regionally. Your responsibilities:Provide dynamic strategic contribution to the direction and senior leaders of key pharmacovigilance activities across portfolio and throughout the clinical development and post-marketing phases of the life cycle including: Lead all signal management activities for assigned product(s)  Support implantation of signal detection strategy approved by VP of Pharmacovigilance  Review adverse event data, literature and other safety-related data for the purpose of signal detection  Collaborate with Clinical Safety and Risk Management (CSRM) physicians, safety scientists, and medical colleagues to review safety data for signal validation, prioritization, assessment and proposed action plans Partner with the Director, Pharmacovigilance – Signal Management to oversee digital signal detection and management tool.  Serve as an administrator of the tool  Propose and implement signal detection methods in the tool  Train, mentor and assist CSRM staff in using the tool.  Oversee signal tracking and signal notifications to external stakeholders  Generate periodic signal management compliance metrics Provide safety contents for risk management plans and periodic aggregate safety reports, including but not limited to PBRER/PSUR, PADER, DSUR, and IND annual reports in collaboration with Clinical Safety and Risk Management (CSRM) physicians, safety scientists, and medical colleagues Assess document requirements, gauge document complexity, and identify information gaps or other potential issues. In collaboration with the relevant project team, the author proposes or contributes to strategies to resolve any identified issues  Reviews applicable regulatory intelligence on global regulations/guidance documents and be able to advise report project teams as a Subject Matter Expert (SME) for signal management.  Understand relationships and dependencies between signal management and documents/analyses produced for regulators across the development of RMPs, DSURs, PBRERs, and other annual reports and/or deliverables  Provide project teams with expertise on regulatory requirements and corporate policies governing documents for regulatory submission  Provide project teams with expertise and strategic guidance on analysis and presentation of safety data and on benefit-risk assessment in documents  Produce high quality, accurate, and fit-for-purpose evaluation documents with clear conclusions, in response to internal or regulatory authority request for safety reasons  Review the worldwide medical/scientific literature to identify signals and applicable information for inclusion in aggregate safety reports in collaboration with CSRM colleagues  Draft regulatory response documents such as PRAC assessment reports  Draft other medical writing deliverables as needed If you are interested to take on these responsibilities you should have the following requirements:Degree in Pharmacy, Nursing, Epidemiology, Biosciences or equivalent healthcare degree with pharmaceutical industry background  Minimum 8 years relevant medical, scientific/clinical, or pharmaceutical experience, including at least 5 years’ experience in Pharmacovigilance  Excellent written and verbal communication skills with the ability to interpret and present safety data  Knowledge of FDA and EMA regulations, ICH guidelines, Good Clinical Practices, and the drug development process  Knowledge of drug safety/pharmacovigilance practices and tools  Ability to coordinate and prioritize multiple projects in a fast-paced environment with limited to little supervision  Background in vaccines is a plus  Demonstrated ability to develop, execute and follow-through complex projects to completion  Skilled at working effectively in a collaborative team environment where results are achieved through influence and the incorporation of multiple points of view  Independently motivated, detail oriented and strong problem-solving ability  Excellent organizational skills and demonstrated ability to multitask in a fast-paced environment with changing priorities  Excellent written and verbal communication skills with the ability to interact across multiple functions Did we spark your interest? We look forward to receiving your online application. Please note a Swiss Work permit is mandatory and your residence needs to be in Switzerland for this position. 
    • basel, basel-stadt
    • contract
    Do you want to work in a big pharmaceutical company? Do you have some experience in RA CMC? You should then read the following lines! Our client, based in Basel, is looking for a Regulatory Affairs CMC Senior Manager for a mission until december 2022. Job Purpose:Under supervision, provide timely preparation of high quality CMC regulatory documentation and support to contribute to global regulatory submissions and strategies. Major Activities: 1.Author high-quality CMC documentation for HA submission, with support and guidance, applying agreed CMC global regulatory strategies, assuring technical congruency and regulatory compliance, meeting agreed upon timelines and e-publishing requirements throughout project lifecycle.2.Prepare CMC responses to health authority questions during development, registration and product lifecycle.3.Identify the required documentation for global submissions and negotiate the delivery of approved technical source documents in accordance with project timelines.4.Identify content, quality and/or timeliness issues with source documents, or any other potential authoring issues that may impact submission quality or timelines, as early as possible.5.Keep knowledge up to date with regard to regulatory guidelines and requirements in all global regions as well as for new technical trends.6.Actively participate as a member of the global team by contributing to the regulatory strategy, identifying the critical issues and lessons learned.7.Establish and maintain sound working relationships with partners and customers.8.Assume activities in support of the general department such as DRAGON support, annual and product renewal writing, coordination/collection/storage of source documentation needed for direct submission to HAs, other database entry activities (specialized department functions). Ideal Background:- Education (minimum/desirable):Minimum:Degree in Science (e.g. Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalentDesirable:Advanced Degree in Science (Chemistry, Pharmacy, Biochemistry, Biotechnology) or equivalent. - Languages: Fluent English required (oral and written).Good skills in site (local) language desired (oral) - Experience/Professional requirement:1.Regulatory experience preferred, and/or experience in drug/biopharmaceuticals2.Working knowledge of chemistry/biotechnology, analytics or pharmaceutical technology. Knowledge of the drug development process desirable. Ability to critically evaluate data from a broad range of scientific disciplines.3.Knowledge/experience of regulations, guidelines for NCEs and product life cycle maintenance desirable.4.Ability to work successfully with extended, multinational project teams and coordinate activities simultaneously on multiple projects under pressure of time and workload.5.Effective planning, organizational and interpersonal skills.6.Reasonable approach to risk assessment.7.Excellent written/spoken communication and negotiation skills.8.Computer literacy. Do not waste any minutes, apply now!  We are looking forward to receiving your application.Please note that only candidates with a valid work permit or who are EU/EFTA citizens will be considered. 
    Do you want to work in a big pharmaceutical company? Do you have some experience in RA CMC? You should then read the following lines! Our client, based in Basel, is looking for a Regulatory Affairs CMC Senior Manager for a mission until december 2022. Job Purpose:Under supervision, provide timely preparation of high quality CMC regulatory documentation and support to contribute to global regulatory submissions and strategies. Major Activities: 1.Author high-quality CMC documentation for HA submission, with support and guidance, applying agreed CMC global regulatory strategies, assuring technical congruency and regulatory compliance, meeting agreed upon timelines and e-publishing requirements throughout project lifecycle.2.Prepare CMC responses to health authority questions during development, registration and product lifecycle.3.Identify the required documentation for global submissions and negotiate the delivery of approved technical source documents in accordance with project timelines.4.Identify content, quality and/or timeliness issues with source documents, or any other potential authoring issues that may impact submission quality or timelines, as early as possible.5.Keep knowledge up to date with regard to regulatory guidelines and requirements in all global regions as well as for new technical trends.6.Actively participate as a member of the global team by contributing to the regulatory strategy, identifying the critical issues and lessons learned.7.Establish and maintain sound working relationships with partners and customers.8.Assume activities in support of the general department such as DRAGON support, annual and product renewal writing, coordination/collection/storage of source documentation needed for direct submission to HAs, other database entry activities (specialized department functions). Ideal Background:- Education (minimum/desirable):Minimum:Degree in Science (e.g. Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalentDesirable:Advanced Degree in Science (Chemistry, Pharmacy, Biochemistry, Biotechnology) or equivalent. - Languages: Fluent English required (oral and written).Good skills in site (local) language desired (oral) - Experience/Professional requirement:1.Regulatory experience preferred, and/or experience in drug/biopharmaceuticals2.Working knowledge of chemistry/biotechnology, analytics or pharmaceutical technology. Knowledge of the drug development process desirable. Ability to critically evaluate data from a broad range of scientific disciplines.3.Knowledge/experience of regulations, guidelines for NCEs and product life cycle maintenance desirable.4.Ability to work successfully with extended, multinational project teams and coordinate activities simultaneously on multiple projects under pressure of time and workload.5.Effective planning, organizational and interpersonal skills.6.Reasonable approach to risk assessment.7.Excellent written/spoken communication and negotiation skills.8.Computer literacy. Do not waste any minutes, apply now!  We are looking forward to receiving your application.Please note that only candidates with a valid work permit or who are EU/EFTA citizens will be considered. 
    • basel, basel-stadt
    • contract
    For our pharmaceutical client in Basel, we are looking for a  Regulatory Affairs CMC ManagerStart: asapContract: until Dec 2021, with possibility of extensionJob Purpose:Under supervision, provide timely preparation of high quality CMC regulatory documentation and support to contribute to global regulatory submissions and strategies.Major Activities:Author high-quality CMC documentation for HA submission, with support and guidance, applying agreed CMC global regulatory strategies, assuring technical congruency and regulatory compliance, meeting agreed upon timelines and e-publishing requirements throughout project lifecycle.Prepare CMC responses to health authority questions during development, registration and product lifecycle.Identify the required documentation for global submissions and negotiate the delivery of approved technical source documents in accordance with project timelinesIdentify content, quality and/or timeliness issues with source documents, or any other potential authoring issues that may impact submission quality or timelines, as early as possible.5.Keep knowledge up to date with regard to regulatory guidelines and requirements in all global regions as well as for new technical trends.6.Actively participate as a member of the global team by contributing to the regulatory strategy, identifying the critical issues and lessons learned.Establish and maintain sound working relationships with partners and customers.Assume activities in support of the general department such as DRAGON support, annual and product renewal writing, coordination/collection/storage of source documentation needed for direct submission to HAs, other database entry activities (specialized department functions).Ideal Background:Degree in Science (e.g. Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent. Desirable: Advanced Degree in Science (Chemistry, Pharmacy, Biochemistry, Biotechnology) or equivalent.Languages: Fluent English required (oral and written).Experience/Professional requirement:Regulatory experience preferred, and/or experience in drug/biopharmaceuticalsWorking knowledge of chemistry/biotechnology, analytics or pharmaceutical technology. Knowledge of the drug development process desirable. Ability to critically evaluate data from a broad range of scientific disciplines.Knowledge/experience of regulations, guidelines for NCEs and product life cycle maintenance desirable.Ability to work successfully with extended, multinational project teams and coordinate activities simultaneously on multiple projects under pressure of time and workload.Effective planning, organizational and interpersonal skills.Reasonable approach to risk assessment.Excellent written/spoken communication and negotiation skills.
    For our pharmaceutical client in Basel, we are looking for a  Regulatory Affairs CMC ManagerStart: asapContract: until Dec 2021, with possibility of extensionJob Purpose:Under supervision, provide timely preparation of high quality CMC regulatory documentation and support to contribute to global regulatory submissions and strategies.Major Activities:Author high-quality CMC documentation for HA submission, with support and guidance, applying agreed CMC global regulatory strategies, assuring technical congruency and regulatory compliance, meeting agreed upon timelines and e-publishing requirements throughout project lifecycle.Prepare CMC responses to health authority questions during development, registration and product lifecycle.Identify the required documentation for global submissions and negotiate the delivery of approved technical source documents in accordance with project timelinesIdentify content, quality and/or timeliness issues with source documents, or any other potential authoring issues that may impact submission quality or timelines, as early as possible.5.Keep knowledge up to date with regard to regulatory guidelines and requirements in all global regions as well as for new technical trends.6.Actively participate as a member of the global team by contributing to the regulatory strategy, identifying the critical issues and lessons learned.Establish and maintain sound working relationships with partners and customers.Assume activities in support of the general department such as DRAGON support, annual and product renewal writing, coordination/collection/storage of source documentation needed for direct submission to HAs, other database entry activities (specialized department functions).Ideal Background:Degree in Science (e.g. Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent. Desirable: Advanced Degree in Science (Chemistry, Pharmacy, Biochemistry, Biotechnology) or equivalent.Languages: Fluent English required (oral and written).Experience/Professional requirement:Regulatory experience preferred, and/or experience in drug/biopharmaceuticalsWorking knowledge of chemistry/biotechnology, analytics or pharmaceutical technology. Knowledge of the drug development process desirable. Ability to critically evaluate data from a broad range of scientific disciplines.Knowledge/experience of regulations, guidelines for NCEs and product life cycle maintenance desirable.Ability to work successfully with extended, multinational project teams and coordinate activities simultaneously on multiple projects under pressure of time and workload.Effective planning, organizational and interpersonal skills.Reasonable approach to risk assessment.Excellent written/spoken communication and negotiation skills.
    • basel, basel-stadt
    • contract
    Do you want to work in a big pharmaceutical company? Do you have experience in leading regulatory submissions? You should then read the following lines! Our client, based in Basel, is looking for a Senior Global Program Regulatory Manager for a 6 months contract. The Senior Global Program Regulatory Manager works independently under limited supervision to provide strategic and operational regulatory direction and may support the DRA global program team (GPT) representative and/or GTAL for programs through development, registration and approval/post approval. The Sr GPRM ensures the execution of regulatory plans in line with global regulatory strategy in close collaboration with the RA global program team (GPT) representative and/or GTAL. In certain cases, the GPRM may be the GPT representative. The Sr GPRM is a member of the DRA sub team and may indirectly report to the DRA GPT representative for the project and has responsibility for leading regional RA sub teams. Major Accountabilities: Regulatory Strategy1. Responsible for implementing regulatory strategy and managing operational activities for assigned regions.2. Provides input into global regulatory strategy and contributes to Regulatory Functional Plan (RFP) and Seed Document, or their equivalents, including identification of gaps or risks in global strategic plan for assigned regions.3. Partners with regions to align on regulatory strategy in order to fulfil business objectives4. Implements RFP across assigned regions.5. Works with RA GPT representative and/or GTAL to plan and facilitate presentations to Novartis regulatory boards on regulatory strategy.6. Works with RA GPT representative and/or GTAL to interact with regulatory consultants/advisors for global strategic input and challenge.7. Develops and implements regulatory readiness with other line functions, Country Pharma8. Organizations and key opinion leaders, and ensures integration with global regulatory readiness with RA GPT representative and/or GTAL.9. Represents RA on or leads sub-teams as required. HA Interactions1. Determines requirements and sets objectives for Health Authority (HA) interactions with RA GPT representative and/or GTAL.2. Facilitates preparation and finalization of briefing books and contributes to preparation of summary documents.3. Develops and implements plans for timely response to HA requests and coordinates responses.4. Leads rehearsals for HA meetings as appropriate.5. Leads HA meetings independently or with RA GPT representative and/or GTAL as appropriate.6. May serve as local HA liaison depending on location (e.g., FDA or EMA). Submissions and Approvals1. Implements strategy across regions in line with global strategy.2. Identifies issues, gaps, and trade-offs affecting optimal and timely submission and approval.3. Proposes options to minimize risk.4. Drives coordination, planning, and submission of dossiers in assigned regions worldwide.5. Review of global dossier summary documents.6. Develops and implements plans to avoid/minimize clock stops during submission review.7. Reviews, approves and submits Clinical Trial Applications (CTAs) and Investigational New Drugs (INDs).8. Reviews and submits Risk Management Plans.9. May lead negotiations for regional approvals independently or with RA GPT representatives and/or GTAL.10. Responsible for facilitating timely submission and approval of dossiers with HAs under the guidance of the RA GPT representative and/or GTAL. Prescribing Information1. Contributes to the development of the Development Core Data Sheet (DCDS) and Core Data Sheet (CDS) with RA GPT representative and/or GTAL, consistent with development data and commercial objectives of the TPP.2. Generates local PIs, ensuring that they are integrated with the CDS, TPP and regulatory strategy, and are commercially competitive.3. Identifies potential label issues/gaps and develops regulatory label negotiation strategy with contingency planning.4. Revises label as needed to achieve timely HA approval with best possible label based on data available.5. Responsible for ensuring necessary updates or required reviews of local labeling and to capture deviations to maintain alignment with the CDS in conjunction with RA GL. Regional Excellence and Compliance1. Responsible for finalization and on time submission of annual reports and renewals across assigned regions.2. Responsible for appropriate entering and quality of product specific attributes in the compliance database.3. Ensures regulatory compliance for assigned projects and keeps records of all major HA interactions in the validated document management system.4. Ensures quality and compliance with global regulatory requirements (regions responsible) and adherence to regulatory internal policies and processes.5. Provide support as needed for non-project related regional excellence activities. Promotional/Non-promotional Review1. Reviews promotional and non-promotional materials and press releases as required and work with RA GPT representative and/or GTAL to ensure messages are consistent with Novartis policies and guidelines.  Key Performance Indicators: 1. Successful implementation of global regulatory strategy for timely submissions and approvals with the best possible labels based on available data.2. Identification of main HA issues for Seed Document.3. Participation in relevant Regulatory Boards leading to valuable input from these Boards.4. Successful participation in HA interactions to achieve business objectives.5. Provides comprehensive regulatory feedback to achieve global business objectives.  Requirements: EducationScience based BS or MS with requisite experience and demonstrated capability. Advanced degree (MD, Ph D, PharmD) preferred. Experience• Strong knowledge of regulatory submission and approval processes in 1 or more major regions.• Experience leading regulatory submissions and approvals in at least 1 major region.• Experience in HA negotiations.• 4-6 years involvement in regulatory and drug/biologic development spanning activities in Phases I-IV in the following areas:o Innovation in regulatory strategy.o Prior history with post-marketing/brand optimization strategies and commercial awareness preferred.o Involvement in dossier submissions and approvals.o Proven ability to analyze and interpret efficacy and safety data.o Regulatory operational expertise. Do not waste any minutes, apply now! We are looking forward to receiving your application.Please note that only candidates with a valid work permit or who are EU/EFTA citizens will be considered.
    Do you want to work in a big pharmaceutical company? Do you have experience in leading regulatory submissions? You should then read the following lines! Our client, based in Basel, is looking for a Senior Global Program Regulatory Manager for a 6 months contract. The Senior Global Program Regulatory Manager works independently under limited supervision to provide strategic and operational regulatory direction and may support the DRA global program team (GPT) representative and/or GTAL for programs through development, registration and approval/post approval. The Sr GPRM ensures the execution of regulatory plans in line with global regulatory strategy in close collaboration with the RA global program team (GPT) representative and/or GTAL. In certain cases, the GPRM may be the GPT representative. The Sr GPRM is a member of the DRA sub team and may indirectly report to the DRA GPT representative for the project and has responsibility for leading regional RA sub teams. Major Accountabilities: Regulatory Strategy1. Responsible for implementing regulatory strategy and managing operational activities for assigned regions.2. Provides input into global regulatory strategy and contributes to Regulatory Functional Plan (RFP) and Seed Document, or their equivalents, including identification of gaps or risks in global strategic plan for assigned regions.3. Partners with regions to align on regulatory strategy in order to fulfil business objectives4. Implements RFP across assigned regions.5. Works with RA GPT representative and/or GTAL to plan and facilitate presentations to Novartis regulatory boards on regulatory strategy.6. Works with RA GPT representative and/or GTAL to interact with regulatory consultants/advisors for global strategic input and challenge.7. Develops and implements regulatory readiness with other line functions, Country Pharma8. Organizations and key opinion leaders, and ensures integration with global regulatory readiness with RA GPT representative and/or GTAL.9. Represents RA on or leads sub-teams as required. HA Interactions1. Determines requirements and sets objectives for Health Authority (HA) interactions with RA GPT representative and/or GTAL.2. Facilitates preparation and finalization of briefing books and contributes to preparation of summary documents.3. Develops and implements plans for timely response to HA requests and coordinates responses.4. Leads rehearsals for HA meetings as appropriate.5. Leads HA meetings independently or with RA GPT representative and/or GTAL as appropriate.6. May serve as local HA liaison depending on location (e.g., FDA or EMA). Submissions and Approvals1. Implements strategy across regions in line with global strategy.2. Identifies issues, gaps, and trade-offs affecting optimal and timely submission and approval.3. Proposes options to minimize risk.4. Drives coordination, planning, and submission of dossiers in assigned regions worldwide.5. Review of global dossier summary documents.6. Develops and implements plans to avoid/minimize clock stops during submission review.7. Reviews, approves and submits Clinical Trial Applications (CTAs) and Investigational New Drugs (INDs).8. Reviews and submits Risk Management Plans.9. May lead negotiations for regional approvals independently or with RA GPT representatives and/or GTAL.10. Responsible for facilitating timely submission and approval of dossiers with HAs under the guidance of the RA GPT representative and/or GTAL. Prescribing Information1. Contributes to the development of the Development Core Data Sheet (DCDS) and Core Data Sheet (CDS) with RA GPT representative and/or GTAL, consistent with development data and commercial objectives of the TPP.2. Generates local PIs, ensuring that they are integrated with the CDS, TPP and regulatory strategy, and are commercially competitive.3. Identifies potential label issues/gaps and develops regulatory label negotiation strategy with contingency planning.4. Revises label as needed to achieve timely HA approval with best possible label based on data available.5. Responsible for ensuring necessary updates or required reviews of local labeling and to capture deviations to maintain alignment with the CDS in conjunction with RA GL. Regional Excellence and Compliance1. Responsible for finalization and on time submission of annual reports and renewals across assigned regions.2. Responsible for appropriate entering and quality of product specific attributes in the compliance database.3. Ensures regulatory compliance for assigned projects and keeps records of all major HA interactions in the validated document management system.4. Ensures quality and compliance with global regulatory requirements (regions responsible) and adherence to regulatory internal policies and processes.5. Provide support as needed for non-project related regional excellence activities. Promotional/Non-promotional Review1. Reviews promotional and non-promotional materials and press releases as required and work with RA GPT representative and/or GTAL to ensure messages are consistent with Novartis policies and guidelines.  Key Performance Indicators: 1. Successful implementation of global regulatory strategy for timely submissions and approvals with the best possible labels based on available data.2. Identification of main HA issues for Seed Document.3. Participation in relevant Regulatory Boards leading to valuable input from these Boards.4. Successful participation in HA interactions to achieve business objectives.5. Provides comprehensive regulatory feedback to achieve global business objectives.  Requirements: EducationScience based BS or MS with requisite experience and demonstrated capability. Advanced degree (MD, Ph D, PharmD) preferred. Experience• Strong knowledge of regulatory submission and approval processes in 1 or more major regions.• Experience leading regulatory submissions and approvals in at least 1 major region.• Experience in HA negotiations.• 4-6 years involvement in regulatory and drug/biologic development spanning activities in Phases I-IV in the following areas:o Innovation in regulatory strategy.o Prior history with post-marketing/brand optimization strategies and commercial awareness preferred.o Involvement in dossier submissions and approvals.o Proven ability to analyze and interpret efficacy and safety data.o Regulatory operational expertise. Do not waste any minutes, apply now! We are looking forward to receiving your application.Please note that only candidates with a valid work permit or who are EU/EFTA citizens will be considered.

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