Head of Regulatory Affairs
2 weeks ago
Walker Cole International is working with an exciting global pharmaceutical company that is recruiting for a Head of Regulatory Affairs (UK/EU) to join a growing Pharmaceutical business on a permanent basis.
The organisation is an innovative business with a broad portfolio of products across a range of therapeutics and dosage forms. The company offers a competitive salary and flexible working policy, with time in the office and working from home. As the Head of Regulatory Affairs you will be responsible for all lifecycle maintenance activities across the product portfolio for the business and lead a small team.
The main responsibilities will include:
- Develop Regulatory strategies post approval maintenance and submissions to UK + EU Markets, MRP, Centralised Procedure (CP) and Decentralised Procedure (DCP).
- Manage routine Manufacturing Authorisation (MA) maintenance activities for National and MRP procedures including compilation and submission of variations and renewals.
- Ensure submissions of Marketing Authorisation Applications (MAAs) in European and Global territories can be successful.
The successful candidate will:
- Have a Life Science degree or equivalent
- Significant experience in the pharmaceutical industry leading a Regulatory Affairs Function
- Strong knowledge of UK and EU Regulations
- Proven experience in Regulatory Affairs within either an R&D or Established product environment
Regulatory Affairs | RA | Senior Manager | Manager | EU | European Union | MHRA | EMA | European Medicines Agency | Post-approval | New Product Introduction | Product Launch | MAA | Marketing Authorisation Application | Lifecycle Maintenance | Rest of World | Emerging Markets |
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