Regulatory Affairs Specialist

4 days ago

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

We are seeking an experienced Regulatory Affairs professional to join our team at Pro4orm People Ltd. Our client is a dynamic and fast-growing business with a strong entrepreneurial spirit and a pipeline of exciting opportunities.

The Regulatory Affairs Manager will be responsible for executing various regulatory activities related to the EMEA and UK regions. This is a key role that requires strong technical expertise and excellent communication skills.

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 and maintenance of Manufacturer's/Importer licence (MIA).
  • 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, 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.
  • Manage or guide more junior staff when required.

Requirements:

  • Life Sciences degree or equivalent is essential.
  • An in-depth understanding and experience of EU regulatory requirements, including marketing authorisation submissions and maintenance activities on a European level.
  • Experience working in a UK affiliate is a requirement.
  • Experience in other non-EU markets in the region is an advantage.
  • Proven success in the timely management of regulatory approval procedures.
  • Ability to work to deadlines and prioritise numerous projects simultaneously.
  • Ability to work independently and within a team.
  • Excellent verbal and written communication skills.
  • Advanced IT skills, including Excel and other MS Office tools, regulatory affairs information systems, and databases.
  • Ability to work in a multicultural environment.

What We Offer:

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

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