Science & Technology

Regulatory Affairs Specialist

Not Specified

Regulatory Affairs Specialist, Weybridge, Surrey
£40k – £45k

  • Private pharmaceutical specialist
  • Innovative, people focused environment
  • Fast paced, dynamic environment

Take responsibility for managing regulatory aspects of product development projects intended for inclusion into MAA’s and lifecycle management of approved Marketing Authorisations.

THE ROLE…

  • Develop the technical quality data, non-clinical and clinical data of selected product to eCTD standard to support MAA.
  • Prepare and submit new Marketing Authorisation Applications (MAAs).
  • Manage regulatory aspects of product development projects for licenced products
  • Complete QMS and financial management documentation promptly
  • To keep up to date with regulatory and industry standards and apply to current projects.
  • Travel to and spend time as required at supplier, contract manufacturer or other potential partner sites.

WHAT YOU WILL NEED…

  • Previous experience of a Regulatory Affairs role, ideally with MAA experience and life-cycle management.
  • Ability to prepare, review and maintain product information and CMC documentation.
  • Experience of product development and new applications.
  • Post marketing experience including variations, renewals and labelling
  • Experience developing and implementing regulatory strategies.
  • Ability to establish and maintain effective working relationships with internal and external stakeholders.
  • Experience in writing / reviewing of IMPD’s/MAA’s.

WHY YOU WILL LOVE WORKING HERE…

Great team and collaborative environment, lots of opportunity within a growing successful business. Opportunity to gain experience with a global business. Company size allows for candidates to make their mark and have an impact on the business as a whole.

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Employment Type Permanent

Advertiser Type Agency