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Regulatory Affairs Specialist

2 months 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. As a dynamic and fast-growing business, we are looking for a talented individual to take on the role of Regulatory Affairs Manager.

This is a challenging opportunity for a skilled Regulatory Affairs professional to take responsibility for and execute various regulatory activities related to the EMEA and UK region. The successful candidate will work closely with our team to ensure compliance with regulatory requirements and contribute to the strategic development of our regulatory function.

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 the 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 database.
  • Maintenance of a regulatory archive (dossiers, documents, electronic media).
  • Prepare regular reports for regulatory and management purposes.
  • Support to the various business functions (e.g. portfolio, out licensing, launch management).
  • Proactively contribute to the strategic development of the regulatory function as a whole and hence to the successful development of the commercial operations in Europe, Middle East and Africa.
  • Ensure development of 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 able to successfully prioritise numerous projects simultaneously.
  • Ability to work independently as well as within a team.
  • Excellent verbal and written communication skills.
  • IT skills at an advanced level (Excel and other MS Office tools, various Regulatory Affairs Information Systems such as eCTD publishing tools, databases and tracking systems, CESP, MHRA portal, etc.).
  • 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%.