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Senior Regulatory Affairs Specialist

3 months ago

Kent, United Kingdom Cpl Life Sciences Full time €55,000

Job Title: Senior Regulatory Affairs Specialist

Employment Type: Permanent, Full time

Location: Kent UK, 3 days on-site per week. (Hybrid)

Salary: Up to £55,000

Senior Regulatory Affairs Specialist opportunity working for a growing pharmaceutical company that specializing in medicinal, non-medicinal, medical devices, and OTC products. The business is increasingly growing and is looking for a personable and detail-oriented professional to join the team.

Due to the size of the business, a well versed Regulatory Affairs professional is required to join the organisation and support all areas of Regulatory. You will be responsible for managing regulatory submissions in the UK and European markets including supporting over 150 product licenses. In the role, you will be supporting MA transfers, new MAAs, variations, and renewals and labelling changes.

Responsibilities

  • Take responsibility for post-approval activities including, variations (type 1a, 1b, and type 2), renewals, license changes, and CMC change controls.
  • Preparation, of new MAA in the UK and Europe and support with any new registration applications.
  • Sound understanding of MA transfers.
  • Supporting labelling and artwork changes (SmPc, PIL, and mock-ups)
  • Preparation, submission, and management of approvals of National, MRP, DCP, and CP applications in the UK and European region.

Requirements

  • Bachelor’s degree or higher in Life Sciences or technical field.
  • 4 years of relevant regulatory experience.
  • A strong communicator who is able to navigate through difficult conversations with senior stakeholders.
  • Previous EU market experience with strong experience submitting through MRP, DCP and national procedures.

This position allows for great career progression opportunities as well as the chance to work for a growing organisation. Due to the size of the business it will allow for excellent exposure and a chance to work directly with the Regulatory Lead.

To apply for this role you must have the full right to work in the UK as this employer does not provide sponsorship. For more information please contact lucy.kirkaldy@cpl.com