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    • basel, basel-stadt
    • contract
    For one of our clients in Basel we are looking for a Regulatory Scientist, Global Regulatory Affairs for a project until June 2022: Reason for opening: maternity leave cover Job Description: The Regulatory Scientist provides support to the Regional Regulatory Liaison, Regional Therapeutic Area Leader and/or Global Regulatory Leader (GRL) for regulatory activities for products in the assigned portfolio, including assuring that content and intent of regulatory filings support the global regulatory strategy. Key responsibilities include the following and may vary: 1. Input in development, post-approval and life cycle managemento Participate in global regulatory team meetings as appropriate;o Advise the regulatory team on applicable regulatory requirements, project specific regulatory issues as assigned;o Develop an understanding of the regional regulatory environment, competitor intelligence and therapeutic area.2. Liaison with Regulatory Agencies and Local Operating Companieso Act as back-up for contact with Regulatory Agencies as needed;o Draft cover letters for Regulatory Agency communication;o Assist in the preparation of meetings with Regulatory Agencies;o Liaise with LOCs, and ensure responses to queries are made in a in timely manner, and that content is consistent with the regulatory strategy.3. Input in process developmento Assist in development and improvement of processes related to regulatory submissions;4. Clinical Trialso Review clinical trial plans and protocols and ensure alignment with regulatory requirements;4.1. Health Authority Submissions (e.g. Briefing Books, Scientific advicepackages, Marketing Authorization Applications (MAAs), New DrugApplications (NDAs) or equivalent regional or national documents)o Provide regulatory support throughout registration process and life-cycle management;o Advise team in required documents and submission strategies (incollaboration with LOCs as appropriate)o Assist with timely availability of submission documents and ensure that all document components are in place on timeo Draft and review some document content (depending on level ofregulatory knowledge/expertise)o Prepare, hold and lead cross functional team meetings as appropriateo Understand submission details and liaise with Submission Managemento Review and approve submission planso Review of submission documents to ensure compliance with regulatoryrequirementso Assist with submission and acceptance of the submission packageo Ensure country-specific submission packages are made available to the LOCs in accordance with agreed plans.4.2 Generalo Provide regulatory input for and appropriate follow-up to inspections,audits, litigation support and product complaints; o Serve as the Regulatory representative on specific multi-discipline teams;o Keep abreast of current and pending approvals in specific therapeuticareas and is knowledgeable of laws, guidances and requirements relatedto those areas. Principle responsibilities for the Regulatory Scientist, include: o Responsible to manage own capacity and assist visibility of capacity for their work group and for RSMO (5%)o Responsible for assigned projects to ensure strategic regulatory alignment across all functional areas. Supports all regulatory activities associated with the development, post-approval and life-cycle management for designated products. Provides regulatory content support for products by interacting with project teams, LOCs and regulatory agencies (as appropriate) and supporting submissions as appropriate. Provides guidance and support to product development teams on regulatory issues.(65-75%)o Provide other general support on an as needed basis e.g. provide regulatory input and follow-up for inspections, audits, litigation support and products complaints (as appropriate) (20-30%) Qualifications Education & Experience:o University degree – medical or paramedical (pharmacy, biology, veterinary etc.), or equivalent by experience;o Minimum 5 years experience in regulatory affairs o Teamwork experience. Knowledge:o Understanding of the drug development process and regulatory submission and approval processo Knowledge of the regulatory environment, guidelines and practices of region Required Technical Competencies & Knowledge: o Regulatory Affairs competencies and proficiency levels vary based on role and level and may include: Applied Technical Knowledge, Busines Acumen, Decision Making and Prioritization, External Focus, Leading and Influencing and Persuasive Communication.o Submissions Knowledge of regulatory requirements related to submissions and of filing registration process. Understands dossier component requirementso Ability to critically review and compile dossier componentso Understands submission requirements for lifecycle submissions e.g., protocol amendments, post-approval variations, annual reports, PSUR’s, renewal applicationso Knowledge of Microsoft programs as well as electronic management systems (e.g. ERIS, GRAIL) Regulatory Intelligenceo Understands competitive landscape, e.g., views of HA, regulatory precedence, labelling differences and therapeutic area issueso Up-to-date knowledge of current and pending approvals in specific therapeutic areas. Knowledge of laws, guidances and requirements and their implications related to specific therapeutic areaso Basic medical/scientific understanding in a clinical area Regulatory Strategyo Provide strategic input and technical guidance on regulatory requirements to development teamso Understands life cycle of drug product from discovery through marketing and post-approval requirementso Ability to interpret and apply local regulations and guidances to the life cycle of a drug producto Basic medical/scientific understanding of clinical trials and drug development Health Authority Expertiseo Knowledge of how Health Authorities operateso General knowledge of HA organizational structure and individual responsibilities in those structureso General knowledge of HA timelines for reviewing submissionso Organize and assist in executing HA meetings Big advantage: Experience in Pulmonary Hypertension / Orphan Diseases
    For one of our clients in Basel we are looking for a Regulatory Scientist, Global Regulatory Affairs for a project until June 2022: Reason for opening: maternity leave cover Job Description: The Regulatory Scientist provides support to the Regional Regulatory Liaison, Regional Therapeutic Area Leader and/or Global Regulatory Leader (GRL) for regulatory activities for products in the assigned portfolio, including assuring that content and intent of regulatory filings support the global regulatory strategy. Key responsibilities include the following and may vary: 1. Input in development, post-approval and life cycle managemento Participate in global regulatory team meetings as appropriate;o Advise the regulatory team on applicable regulatory requirements, project specific regulatory issues as assigned;o Develop an understanding of the regional regulatory environment, competitor intelligence and therapeutic area.2. Liaison with Regulatory Agencies and Local Operating Companieso Act as back-up for contact with Regulatory Agencies as needed;o Draft cover letters for Regulatory Agency communication;o Assist in the preparation of meetings with Regulatory Agencies;o Liaise with LOCs, and ensure responses to queries are made in a in timely manner, and that content is consistent with the regulatory strategy.3. Input in process developmento Assist in development and improvement of processes related to regulatory submissions;4. Clinical Trialso Review clinical trial plans and protocols and ensure alignment with regulatory requirements;4.1. Health Authority Submissions (e.g. Briefing Books, Scientific advicepackages, Marketing Authorization Applications (MAAs), New DrugApplications (NDAs) or equivalent regional or national documents)o Provide regulatory support throughout registration process and life-cycle management;o Advise team in required documents and submission strategies (incollaboration with LOCs as appropriate)o Assist with timely availability of submission documents and ensure that all document components are in place on timeo Draft and review some document content (depending on level ofregulatory knowledge/expertise)o Prepare, hold and lead cross functional team meetings as appropriateo Understand submission details and liaise with Submission Managemento Review and approve submission planso Review of submission documents to ensure compliance with regulatoryrequirementso Assist with submission and acceptance of the submission packageo Ensure country-specific submission packages are made available to the LOCs in accordance with agreed plans.4.2 Generalo Provide regulatory input for and appropriate follow-up to inspections,audits, litigation support and product complaints; o Serve as the Regulatory representative on specific multi-discipline teams;o Keep abreast of current and pending approvals in specific therapeuticareas and is knowledgeable of laws, guidances and requirements relatedto those areas. Principle responsibilities for the Regulatory Scientist, include: o Responsible to manage own capacity and assist visibility of capacity for their work group and for RSMO (5%)o Responsible for assigned projects to ensure strategic regulatory alignment across all functional areas. Supports all regulatory activities associated with the development, post-approval and life-cycle management for designated products. Provides regulatory content support for products by interacting with project teams, LOCs and regulatory agencies (as appropriate) and supporting submissions as appropriate. Provides guidance and support to product development teams on regulatory issues.(65-75%)o Provide other general support on an as needed basis e.g. provide regulatory input and follow-up for inspections, audits, litigation support and products complaints (as appropriate) (20-30%) Qualifications Education & Experience:o University degree – medical or paramedical (pharmacy, biology, veterinary etc.), or equivalent by experience;o Minimum 5 years experience in regulatory affairs o Teamwork experience. Knowledge:o Understanding of the drug development process and regulatory submission and approval processo Knowledge of the regulatory environment, guidelines and practices of region Required Technical Competencies & Knowledge: o Regulatory Affairs competencies and proficiency levels vary based on role and level and may include: Applied Technical Knowledge, Busines Acumen, Decision Making and Prioritization, External Focus, Leading and Influencing and Persuasive Communication.o Submissions Knowledge of regulatory requirements related to submissions and of filing registration process. Understands dossier component requirementso Ability to critically review and compile dossier componentso Understands submission requirements for lifecycle submissions e.g., protocol amendments, post-approval variations, annual reports, PSUR’s, renewal applicationso Knowledge of Microsoft programs as well as electronic management systems (e.g. ERIS, GRAIL) Regulatory Intelligenceo Understands competitive landscape, e.g., views of HA, regulatory precedence, labelling differences and therapeutic area issueso Up-to-date knowledge of current and pending approvals in specific therapeutic areas. Knowledge of laws, guidances and requirements and their implications related to specific therapeutic areaso Basic medical/scientific understanding in a clinical area Regulatory Strategyo Provide strategic input and technical guidance on regulatory requirements to development teamso Understands life cycle of drug product from discovery through marketing and post-approval requirementso Ability to interpret and apply local regulations and guidances to the life cycle of a drug producto Basic medical/scientific understanding of clinical trials and drug development Health Authority Expertiseo Knowledge of how Health Authorities operateso General knowledge of HA organizational structure and individual responsibilities in those structureso General knowledge of HA timelines for reviewing submissionso Organize and assist in executing HA meetings Big advantage: Experience in Pulmonary Hypertension / Orphan Diseases

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