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Senior Regulatory Submissions Officer (split home and office based)

Hertfordshire   •  £45000 - £55000 per annum  •  Permanent, Full time

CK Clinical are looking for a regulatory affairs professional to join a global pharmaceutical company within their EU central team where you will be responsible for post-launch and MAA submissions.

A global pharmaceutical company.

Hertfordshire ? 2 or 3 days a week from home.

£45,000 to £55,000 (experience dependent) plus package.

? Ensure suitable dossiers (marketing authorization applications / post-approval submissions) are prepared and dispatched on-time
? Ensure on-time submissions for all safety related changes for assigned projects.
? Liaise closely with Business Development, Regulatory Science, Pharmacovigilance, Product Launch, Artwork, Supply Chain and Quality colleagues to ensure alignment in all initiatives.
? Prepare regulatory strategies for new marketing authorization applications / post-approval submissions.

Your Background:
? BSc in Life sciences or related area.
? Extensive hands on Submission experience and experience of interfacing with health authorities and cross functional colleagues is essential.
? Knowledge of MRP/DCP and CP legislation

For more information or to apply for this medical communications role, please contact Julia Day on 01246 457719 or email jday@ckgroup.co.uk. Alternatively, please click on the link below to apply online now.
CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria. Entitlement to work in the EEA is essential. Please quote reference 51762 in all correspondence.


You must have the right to work in the UK. Learn more

  • Agency: CK Group
  • Contact: Julia Day
  • Phone: 01246 457733
  • Reference: 51762
  • Posted: 30th September 2021
  • Expires: 28th October 2021

CK Group

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