Regulatory Affairs Manager

3 days ago


Slough, Slough, United Kingdom Pro4orm People Ltd Full time
Regulatory Affairs Manager

We are seeking an experienced Regulatory Affairs professional to join our team at Pro4orm People Ltd. As a Regulatory Affairs Manager, you will play a key role in ensuring our client's compliance with regulatory requirements in the EMEA and UK regions.

Key Responsibilities:
  • Manage all regulatory activities related to the UK and EU markets, including artwork approvals, maintenance of Manufacturer's/Importer licence (MIA), and record data in relevant regulatory databases.
  • Maintain a regulatory archive (dossiers, documents, electronic media) and prepare regular reports for regulatory and management purposes.
  • Support various business functions, such as portfolio, out-licensing, and launch management, and contribute to the strategic development of the regulatory function.
  • Ensure the development of procedures for compliance purposes and have an in-depth understanding and experience of EU regulatory requirements, including marketing authorisation submissions and maintenance activities.
  • Proven success in the timely management of regulatory approval procedures and ability to work to deadlines, prioritise numerous projects simultaneously, and possess advanced IT skills.
What We Offer:
  • Competitive salary banding plus bonus, up to 12% of PMP
  • 28 days annual leave plus bank and public holidays
  • Life assurance, x4 annual salary
  • Private medical insurance, self and spouse
  • Pension


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