Snr Regulatory Submissions Analyst

  • Salary: £40-43K per annum
  • REF Number: 00049577
  • Consultant:
  • Contact: 01246 457709
  • Date Published: 11.01.2021
  • Sector:
  • Location: Marlow, Bucks, Home Counties
  • Discipline:

CK Group are recruiting for 2 x Snr Regulatory Submissions Analysts to join a Pharmaceutical based in Buckinghamshire. The role is a contract position working on a PAYE basis as no LCC's are permitted.

The Company: Our client is a bold, globalpharmaceutical company. They are focused on developing, manufacturing and commercializing branded pharmaceutical, device, biologic, surgical and regenerative medicine products for patients around the world.

The Role: Publishes submissions withinthe European Region in line with current national and regional requirements for eCTD applications. Works with regional archivists to ensure that published submissions are archived in accordance with local and global SOPs. Provides guidance (and where necessary training) to European Region Regulatory Affairs staff on all aspects of submission formats/requirements and publishing related software/tools as and when required. Builds and maintains relationships with Regulatory and other staff within and outside of the region to ensure effective communication and efficient implementation of regulatory submission strategy and activities. Works collaboratively with colleagues within the International Regulatory Submissions Team across the AMEA,Europe and LACAN regions. Provides support and mentorship to junior colleagues within the team.

Education and Experience

  • Good knowledge of European pharmaceutical regulations and guidelines.
  • Experience in publishing CP, MRP and DCP submissions, including eCTD
  • Good knowledge and experience of all submission types (MAAs, Variations, Renewals, CTAs, ASRs etc)
  • Knowledge/experience in publishing submissions for emerging markets (Middle East, Non-EU Europe etc) would be ideal.

Formore information or to apply for this position, please contact Russell Oakley on 01246 457709 or email roakley@ckgroup.co.uk. Please quote reference 49577 in all correspondence.

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