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Senior Manager Regulatory Affairs

3 months ago

Cambridge UK, Cambridgeshire, United Kingdom CK Group Full time

CK Group are recruiting for a Senior Manager Regulatory Affairs to join a biopharmaceutical company who are based in Uxbridge or Cambridge on a contract basis for 12 months.


Company:

Our client is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.


Location:

The role is based in Uxbridge or Cambridge and offers hybrid/remote working.

Hourly Rate:

£48.92phr PAYE or £64.85phr Umbrella.


Role:

  • Provide regional regulatory support for one or more products and be accountable for developing and executing regional regulatory strategies across the product lifecycle and managing effective agency interactions to support the diversity of regulatory procedures in the EU (inc. PIPs, variations, IMPDs, MAAs).
  • Develops and implements regulatory strategy and executional plans and manages regulatory submissions (e.g., clinical trial and marketing applications) for assigned products in accordance with global filing plans, core labelling documents and regulatory requirements.
  • Define and advise the GRT on regional considerations in developing creative regulatory strategy, lead development of regional regulatory documents and meetings and provide regulatory advice on regional regulatory requirements, mechanisms to optimise product development and to maintain compliance.
  • Co-ordinate and provide guidance to company responses to requests from regulatory authorities, e.g. Response to Questions (RTQs) and act as contact, creating relationships with agency staff.
  • Maintains an awareness of new and developing legislation, regulatory policy and technical Regulatory guidance relating to products, and evaluate and communicate impact.

Your Background:

  • Educated to degree level or above in Life sciences or a related field.
  • Extensive experience in Regulatory Affairs with experience acting as therapeutic area European Regulatory Affairs lead, defining and implement regulatory strategies and executional plans
  • Experience with national legislation and regional regulations relating to medicinal products and an understanding of the regional regulatory procedures for CTAs, MAAs, post approval changes, extensions and renewals.
  • Strong knowledge of and experience in regional regulatory environment in relevant product area, development stage and experience of working directly with the EMA and Centralised Procedure.
  • Experience in Inflammation, Cardiovascular or Bone therapeutic area and experience of working with biotechnology products.


Apply:

It is essential that applicants hold entitlement to work in the UK. Please quote job reference 103639 in all correspondence.