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Regulatory Affairs Consultant

Surrey   •  Contract/Temporary, Full time


Vaccines/Shingrix
Therapeutic Area: Vx  - Shingrix
Number of Resources: 2 FTEs (1 in US and 1 in BE)
Resource Experience: Experience in working in matrixed environment (RA, clinical, cmc, safety, stats, labeling, etc.)  in the development and/or life cycle space. Experience in clinical regulatory/labeling needed for Shingrix.  Able to hit ground running with more minimal onboarding; self-starter; ability to network and problem solve; strong communicator (written and spoken)
Resource Location: US & BE ? but we are in need of strong US expertise as well which may necessitate location in US
Hours per week: 37.5 Hours (Full time)
Target Resource Start: ASAP
Estimated Resource Stop: Min 6 months ? possibly to Q2 of 2022
Tasks to be assigned to selected resource:           

  • To identify regulatory strategy, file content, prepare file plans, drive file prep (using deliverables from matrix), submit file, coordinate/submit responses to RTQs, liaise with authority, partner with Project Manager to track/monitor deliverables. 
  • Review of submissions (including labeling, RTQs and initial filings) to ensure alignment with company position and agency requirements.

  • Agency: Achieva Group Limited
  • Contact: Lewis Coulson
  • Phone: 01727 811 634
  • Reference: BH-31799
  • Posted: 13th July 2021
  • Expires: 10th August 2021

Achieva Group Limited

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