Regulatory Affairs Specialist

4 days ago

Slough, Slough, United Kingdom Pro4orm People Ltd Full time

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:

  • Preparation, submission, and management of variation applications to agreed timelines.
  • Manage and submit Renewals and PSURs in line with specified timelines.
  • Preparation, submission, and management of approvals of National, Mutual Recognition, Decentralised Procedure applications in the region.
  • Preparation and maintenance of the product information (SmPC/PIL).
  • Management of 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).
  • Preparation of 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%.

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