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Regulatory Affairs Manager (12-month Maternity Leave cover), Manchester
Client:
Carrot Recruitment
Location:
Manchester, United Kingdom
Job Category:
Other
EU work permit required:
Yes
Job Reference:
18e6d806f2d0
Job Views:
118
Posted:
09.02.2025
Expiry Date:
26.03.2025
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 centralized procedures.
You
Ideally 5 years’ experience (or equivalent) working in Pharma Regulatory Affairs.
Experience of the centralized 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 licenses in the USA is desired but not essential.
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