Regulatory Affairs Director
7 days ago
We are seeking an experienced Regulatory Affairs professional to join our team at Pro4orm People Ltd as a Senior Manager/Director of Regulatory Affairs.
Key Responsibilities:
- Manage all regulatory activities related to the UK and EU markets, including artwork approvals, maintenance of Manufacturer's/Importer licence (MIA), and other regulatory submissions.
- Record data in relevant regulatory databases and maintain a regulatory archive (dossiers, documents, electronic media).
- Prepare regular reports for regulatory and management purposes, including strategic development of the regulatory function and commercial operations in Europe, Middle East, and Africa.
- Ensure development of procedures for compliance purposes and maintain an in-depth understanding 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, prioritizing numerous projects simultaneously.
- Advanced IT skills, including Excel, MS Office tools, and various Regulatory Affairs Information Systems.
What We Offer:
- 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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