Regulatory Affairs Director

1 day ago

Slough, Slough, United Kingdom Pro4orm People Ltd Full time
Job Description

**Regulatory Affairs Manager**

We are seeking an experienced Regulatory Affairs professional to join our team at Pro4orm People Ltd. As a dynamic and fast-growing business, we are looking for a talented individual to take on the role of Regulatory Affairs Manager.

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.
  • Contribute to the strategic development of the regulatory function and commercial operations in Europe, Middle East, and Africa.
  • Develop procedures for compliance purposes and ensure an in-depth understanding and experience of EU regulatory requirements.
  • Manage regulatory approval procedures and prioritize multiple projects simultaneously.
  • Utilize advanced IT skills, including Excel, MS Office tools, and Regulatory Affairs Information Systems.

Requirements:

  • Proven success in regulatory affairs, with a strong understanding of EU regulatory requirements.
  • Excellent communication and project management skills.
  • Ability to work in a fast-paced environment and prioritize multiple projects.
  • Advanced IT skills, including Excel and MS Office tools.

What We Offer:

  • Competitive salary banding and bonus structure.
  • 28 days annual leave plus bank and public holidays.
  • Life assurance and private medical insurance.
  • Pension scheme.

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