Regulatory Affairs Manager
3 weeks ago
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Regulatory Affairs Manager (12-month Maternity Leave cover), Greater ManchesterClient:Carrot Recruitment
Location:Greater Manchester, United Kingdom
Job Category:Other
EU work permit required:Yes
Job Reference:18e6d806f2d0
Job Views:6
Posted:03.03.2025
Expiry Date:17.04.2025
Job Description:The Role
- Provide regulatory support for all activities conducted by the Company including dossier compilation, variations, change impact assessment, scientific advice applications, paediatric investigation plans, PSUR submissions.
- Manage the generation and maintenance of Registration Dossiers (MAA/CTD) related to the products manufactured, in compliance with applicable legislation.
- Develop the regulatory strategy for new submissions.
- Work on EU projects within centralised procedures.
You
- Ideally 5 years' experience (or equivalent) working in Pharma Regulatory Affairs.
- Experience of the centralised procedure for new products (EMA).
- Working knowledge of the Common Technical Document (CTD).
- Experience of directly dealing with Regulatory agencies.
- Experience of scientific advice, paediatric (Paediatric Investigation Plan) or Orphan procedures is highly desired but not essential.
- Experience in gaining and maintaining product licences in the USA is desired but not essential.
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