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1 job found in Basel-Stadt

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    • basel, basel-stadt
    • temporary
    Do you wish to be part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative ?For our client, this pioneering biotechnology company, we are looking for a: Specialist Regulatory affairs - CTA Regulatory coordinator Location:BaselContract: Temporary for one year.You will provide effective operational and regulatory support for assigned regulatory submission and maintenance activities, including preparation and submission of regulatory dossiers, maintenance of regulatory databases and archives. Your Responsibilities: Support regulatory submission to national HAs world-wise as required: e,g, support for putting together dossiers for submission, coordinating operational activities related to M1 (administrative forms filling in; translations coordination; artworks coordination if required etc.)Prepare and/or co-ordinate the preparation of regulatory documentation to support Clinical Trial Applications/amendments worldwide.Responsible for managing regulatory Clinical Trial Applications submission activities for allocated clinical trials directly to Health Authorities or facilitating the CTA submission by local personnel in their specific country.Liaise with and provide oversight to CRO supporting the CTA submissions and query management.Accountable for the implementation of the global CTA submission strategy, as well as the quality and extensiveness of the CTA regulatory submissions for Clinical Trial Applications, throughout the lifecycle of the trial.Ensure that the mandatory regulatory requirements are in place to comply with country-specific requirements for CTAs or other regulatory submissions as required.Interact with the cross-functional team (Regulatory, Clinical Development, Clinical Operations, Safety, CMC) to ensure optimal execution of the agreed regulatory strategy for development medicinal productsAnticipate and bring solutions for potential regulatory risksMaintain good knowledge of regulatory requirements and guidelines especially European regulations on Clinical trials, or other upcoming regulatory initiatives as assigned (e.g. regulations or guidance on novel product initial registration or lifecycle management).Communicate and educate cross-functional teams on European regulatory requirements and changes in the regulatory landscape.Participate in process improvement initiatives within GRS or the International HQ as requiredMaintain an effective archiving and submissions/approvals tracking records Your profile:Degree in Life Science or related discipline4+ years of experience in the Pharmaceutical industry.2+ years of experience in RegulatoryExperience in the preparation/submission of regulatory documentation to support clinical trials applications/amendments in the European UnionKnowledge of the European drug development process and regulatory requirements (knowledge of ex-Europe regulatory environment would be an advantage)Detailed regulatory submission experience and regulatory knowledgeProven project management experience and leadership skillsExcellent knowledge of English, spoken and writtenVerified ability to lead multi-functional teams, building strong and productive relationships across an organization. You would like to contribute to a fast-thinking and innovative company, changing the industry ? Apply nowPlease note that a valid Swiss work permit or Swiss or EU-25/EFTA citizenship is required for this position 
    Do you wish to be part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative ?For our client, this pioneering biotechnology company, we are looking for a: Specialist Regulatory affairs - CTA Regulatory coordinator Location:BaselContract: Temporary for one year.You will provide effective operational and regulatory support for assigned regulatory submission and maintenance activities, including preparation and submission of regulatory dossiers, maintenance of regulatory databases and archives. Your Responsibilities: Support regulatory submission to national HAs world-wise as required: e,g, support for putting together dossiers for submission, coordinating operational activities related to M1 (administrative forms filling in; translations coordination; artworks coordination if required etc.)Prepare and/or co-ordinate the preparation of regulatory documentation to support Clinical Trial Applications/amendments worldwide.Responsible for managing regulatory Clinical Trial Applications submission activities for allocated clinical trials directly to Health Authorities or facilitating the CTA submission by local personnel in their specific country.Liaise with and provide oversight to CRO supporting the CTA submissions and query management.Accountable for the implementation of the global CTA submission strategy, as well as the quality and extensiveness of the CTA regulatory submissions for Clinical Trial Applications, throughout the lifecycle of the trial.Ensure that the mandatory regulatory requirements are in place to comply with country-specific requirements for CTAs or other regulatory submissions as required.Interact with the cross-functional team (Regulatory, Clinical Development, Clinical Operations, Safety, CMC) to ensure optimal execution of the agreed regulatory strategy for development medicinal productsAnticipate and bring solutions for potential regulatory risksMaintain good knowledge of regulatory requirements and guidelines especially European regulations on Clinical trials, or other upcoming regulatory initiatives as assigned (e.g. regulations or guidance on novel product initial registration or lifecycle management).Communicate and educate cross-functional teams on European regulatory requirements and changes in the regulatory landscape.Participate in process improvement initiatives within GRS or the International HQ as requiredMaintain an effective archiving and submissions/approvals tracking records Your profile:Degree in Life Science or related discipline4+ years of experience in the Pharmaceutical industry.2+ years of experience in RegulatoryExperience in the preparation/submission of regulatory documentation to support clinical trials applications/amendments in the European UnionKnowledge of the European drug development process and regulatory requirements (knowledge of ex-Europe regulatory environment would be an advantage)Detailed regulatory submission experience and regulatory knowledgeProven project management experience and leadership skillsExcellent knowledge of English, spoken and writtenVerified ability to lead multi-functional teams, building strong and productive relationships across an organization. You would like to contribute to a fast-thinking and innovative company, changing the industry ? Apply nowPlease note that a valid Swiss work permit or Swiss or EU-25/EFTA citizenship is required for this position 

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