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Senior Manager Regulatory Affairs

2 months ago

England, United Kingdom Walker Cole International Full time

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 generics and specialty branded product 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 product portfolio 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 procedures and paediatric studies to aid in the regulatory submission process.

The successful candidate will:

  • Have a Life Science degree or equivalent
  • Significant experience in the pharmaceutical industry ideally within specialty products
  • Strong knowledge of EU Regulations
  • Proven experience in EU Regulatory Affairs within either an R&D or Established product environment

Regulatory Affairs | RA | Head of Regulatory Affairs| GMP | Pharmaceutical | Regulatory | Submission | Product Dossiers | EU | Global | MHRA | FDA | Good Manufacturing Practice | CTD | Common Technical Documentation | Module 1 | Module 2 | Module 3 | Module 4 | Module 5 | TMF | Trial Master File | Clinical | R&D