Regulatory Affairs Manager

3 weeks ago


Manchester, United Kingdom TN United Kingdom Full time

Social network you want to login/join with:

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

  1. 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.
  2. Manage the generation and maintenance of Registration Dossiers (MAA/CTD) related to the products manufactured, in compliance with applicable legislation.
  3. Develop the regulatory strategy for new submissions.
  4. Work on EU projects within centralised procedures.

You

  1. Ideally 5 years' experience (or equivalent) working in Pharma Regulatory Affairs.
  2. Experience of the centralised procedure for new products (EMA).
  3. Working knowledge of the Common Technical Document (CTD).
  4. Experience of directly dealing with Regulatory agencies.
  5. Experience of scientific advice, paediatric (Paediatric Investigation Plan) or Orphan procedures is highly desired but not essential.
  6. Experience in gaining and maintaining product licences in the USA is desired but not essential.
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