Interim Regulatory Affairs Manager
2 weeks ago
Interim Regulatory Affairs Manager
Walker Cole International, a modern search company based in the UK, are currently working with an exciting global speciality pharmaceutical company that is currently recruiting for an interim Regulatory Affairs Manager to join the business on a 6 to 12 monthcontract basis (outside IR35). The business are an innovative business with a portfolio of products in the rare-disease category. The business offer a flexible hybrid working policy, with time in the office and working from home.
As the Interim Regulatory Affairs Manager you will be responsible for all lifecycle maintenance activities across the product portfolio for the business and support the team.
The main responsibilities will include:
- Develop Regulatory strategies for innovative and rapid access to new markets
- 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
- Significant experience in the pharmaceutical industry ideally with rare disease capabilities
- Strong knowledge of EU Regulations
- Proven experience in EU Regulatory Affairs within either an R&D or Established product environment
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