Regulatory Affairs Expert

3 days ago


Cambridge, Cambridgeshire, United Kingdom Cpl Life Sciences Full time
Job Overview

We are seeking a highly experienced Senior Director to lead our Regulatory Affairs team at Cpl Life Sciences. This role will provide strategic regulatory advice to clients, taking into account regulatory guidelines and available measures to facilitate regulatory input.

Key Responsibilities:

  • Lead client projects, providing expert regulatory guidance to ensure compliance with relevant regulations.
  • Develop and implement effective regulatory strategies to support drug development activities.
  • Prepare and submit regulatory documents, including orphan drug designation applications and clinical trial authorizations.
  • Cultivate strong relationships with regulatory authorities to ensure successful project outcomes.

About the Role:

  • This is a leadership position that requires a minimum of 12+ years of experience in Regulatory Affairs within a complex therapeutic area.
  • The ideal candidate will have extensive experience in early-stage drug development and be confident with UK, EU, and US health authorities and drug pathways.
  • A strong understanding of EMA procedures and ability to drive global Regulatory Affairs Strategies are essential.
  • The salary for this role is estimated to be £130,000 + Benefits, reflecting the importance of this position in our organization.

Benefits:

  • A competitive salary package, including benefits and bonuses.
  • The opportunity to work with a prestigious global drug development consultancy business.
  • A dynamic and collaborative work environment.

Requirements:

  • A B.Sc. in a life sciences subject and/or a higher degree preferably a PhD but this isn't essential.
  • Excellent written and verbal communication skills.
  • Able to negotiate and concisely express clear positions to stakeholders at all levels.


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