Regulatory Affairs Manager

3 days ago

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

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 compliance with regulatory requirements and supporting the successful development of our commercial operations in Europe, Middle East and Africa.

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 development of procedures for compliance purposes and have an in-depth understanding and experience of EU regulatory requirements.
  • Proven success in the timely management of regulatory approval procedures and ability to work to deadlines and prioritize numerous projects simultaneously.
Requirements:
  • Advanced IT skills, including Excel and other MS Office tools, and various Regulatory Affairs Information Systems.
  • Competitive salary banding plus Bonus – on target achievement of PMP up to 12%.
  • ~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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