Senior Regulatory Affairs Manager - Slough, United Kingdom - WALKER COLE INTERNATIONAL LTD
Description
Walker Cole International is searching for an Senior Regulatory Affairs Manager to join an established global pharmaceutical business on a permanent basis.
The organisation are an innovative business with a broad portfolio of products in both the genericsand CNS therapy areas. The company offer a competitive salary and flexible working policy, with time in the office and working from home.As the Senior Regulatory Affairs Manager you will be responsible for all lifecycle maintenance activities across the productportfolio for the business as well as leading submissions for new products.
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
- Managing centralised prodceudres and paediatric studies to aid in the regulatory submission process.
- Have a Life Science degree or equivalent
- 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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