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Regulatory Affairs Specialist

2 months 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. Our client is a dynamic and fast-growing business with a strong entrepreneurial spirit and a pipeline to match.

The Regulatory Affairs Manager will be responsible for executing various regulatory activities related to the EMEA and UK regions. This is a non-managerial position.

Key Responsibilities:

  • Prepare, submit, and manage variation applications to agreed timelines.
  • Manage and submit Renewals and PSURs in line with specified timelines.
  • Prepare, submit, and manage approvals of National, Mutual Recognition, Decentralised Procedure applications in the region.
  • Prepare and maintain product information (SmPC/PIL).
  • Manage all regulatory activities related to the UK and EU markets (including artwork approvals, maintenance of Manufacturer's / Importer licence (MIA) etc.).
  • Record data in relevant regulatory databases.
  • Maintain a regulatory archive (dossiers, documents, electronic media).
  • Prepare regular reports for regulatory and management purposes.
  • Support various business functions (e.g. portfolio, out licensing, 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.
  • Manage or guide more junior staff when required.

Requirements:

  • Life Sciences degree or equivalent is essential.
  • Experience working in a UK affiliate is a requirement.
  • Experience in other non-EU markets in the region is an advantage.
  • Proven success in timely management of regulatory approval procedures.
  • Ability to work to deadlines and prioritize numerous projects simultaneously.
  • Ability to work independently and within a team.
  • Excellent verbal and written communication skills.
  • Advanced IT skills (Excel, MS Office tools, Regulatory Affairs Information Systems).
  • Ability to work in a multicultural environment.

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 7.5% contribution from employer – minimum employee contribution 0.5%

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