Consultant - Snr Director Regulatory Affairs EU/UK

Posted 13 November 2023
Job type Contract
Contact NameDominic Pritchard

Job description

Snr Director Regulatory - Contract

In collaboration with a well funded fast paced BioTech, BioTalent are looking to connect a seasoned Regulatory Industry professional to fulfil EU and UK requirements in alignment with the Global Team.


This role will offer you

  • 3-6 month rolling contract
  • Ability to work part time
  • Hourly pay rate
  • Remote working


You will be responsible for

  • Being the face/lead of EU Regulatory Affairs, strategy, process and execution.
  • Approvals, Labelling, MAA, Dossier, Submissions
  • Assessment of risks and mitigations


You will bring the following

  • Long standing Regulatory industry experience with availability for 0.8-1.0 FTE
  • Crossfunctional team working ability, mental agility, confidence and successful track record
  • Experience developing and taking MAA through to completion from a Biotech lead product perspective (inclusive of IMPDs, INDs and NDAs)