Senior Specialist Regulatory affairs NCE

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Your tasks

Within our innovative RA team, you will be responsible for:

• Compiling regulatory documents (e.g. clinical trial regulatory dossiers, client data packages, DMFs) in line with regulatory requirements and customer's requests, according to the defined timelines


• Developing dossier content strategies


• Answering deficiency letters from Authorities


• Performing regulatory assessment of changes as part of GMP change control


• Preparing regulatory documents to support post-marketing changes (e.g. "Variations") and submitting them accordingly, where applicable


• Providing regulatory advice to and answering regulatory questions from internal and external customers, throughout the product lifecycle (including development)


• Defining, communicating and keeping RA-related timelines for his/her projects


• Representing RA in project teams for NCEs

TGI Life Sciences is acting as an Employment Agency in relation to this vacancy.