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Regulatory Affairs Manager

3 months ago

South East England, United Kingdom WALKER COLE INTERNATIONAL LTD Full time

Walker Cole International is currently supporting one of their Global Pharmaceutical clients in the South-East of England to hire a Regulatory Affairs Manager on a contract basis, outside IR35 or via umbrella company if needed.

The key responsibilities are:

- Provide a Regulatory strategy for submissions of new MAs and license maintenance variations
- Work with internal and external stakeholders, and Health Authorities
- Manage preparation of registration dossiers and submission of MAAs
- Create and maintain SOPs and working instructions for the RA function

Regulatory Affairs I RA I Regulatory I Submissions I MAA I MA I License Variation I Dossier I Marketing Authorisation Application I Registration Dossier I Marketing Authorisation I Renewal I MRP