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Regulatory Affairs Professional

1 month ago

Cambridge, Cambridgeshire, United Kingdom ProductLife Group Full time
About the Job

In a continuous effort to grow and expand our services, ProductLife Group is looking for a Regulatory Affairs Specialist to join our team in the United Kingdom.

This position plays a vital role in developing our local UK Regulatory Affairs presence, overseeing new regulatory activities related to the UK for multiple clients. You will work closely with a team of dedicated Regulatory Affairs professionals to achieve this goal.

Key Responsibilities:
  • Provide guidance and support to manage submissions and requests from various clients regarding the UK.
  • Contribute to regulatory activities, including pre-licensing, new registrations, and post-approval applications.
  • Assist in preparing Marketing Authorization Applications (MAAs).
  • Prepare and submit documentation for post-approval applications, including Type IA, Type IB, Type II, Renewals, MAH Transfers/COAs.
  • Prepare and submit Technical/Site Transfer Applications.
  • Assist with license applications as needed.
  • Manage artwork generation/labelling/creation/update of product information, reviewing packaging texts, and formatting Summaries of Product Characteristics, Patient Information Leaflets, and labelling (e.g., QRD compliance check).
  • Respond to internal requests for technical and/or regulatory information.
  • Ensure compliance with all regulatory processes, preparing for internal and external audits.
  • Monitor and maintain up-to-date knowledge of national and European guidelines/legislation.
  • Use software packages to produce correspondence and documents, maintain spreadsheets and databases, and locate information and data (e.g., Microsoft Office Suite, Veeva Vault, LorenZ, Trackwise, PromoMat).
  • Perform general regulatory administration duties and compliance requirements.
  • Document and track regulatory submissions and regulatory authority approval.
  • Contribute to data entry in PLG tools to measure KPI metrics for regulatory services.

About Us:

ProductLife Group is a world-class provider of regulatory outsourcing and consulting services for the global life sciences industry. Headquartered in Paris, we have offices in multiple countries around the world.

We were founded in 1994 and have since become a global leader in our field, thanks to our driven and talented employees who work in a supportive team environment with opportunities to learn and grow professionally.

If you're enthusiastic, welcome challenges, and want to grow professionally with a management team committed to your development, apply to join us.