Regulatory Affairs Specialist

1 month ago


London, Greater London, United Kingdom Barrington James Full time

Barrington James is a dynamic and growing global consultancy, seeking a Principal/Senior Consultant (CMC) to join our team.

Job Description

We are looking for an experienced regulatory professional to provide strategic and technical regulatory advice to clients, focusing on CMC aspects of product development. You will oversee regulatory submissions, guide multi-jurisdictional projects, and manage client relationships.

Key Responsibilities:

  • Develop innovative CMC regulatory strategies, gap analyses, and drug development plans.
  • Lead the preparation, authoring, and review of regulatory documents (INDs, IMPDs, MAAs, etc.).
  • Represent clients in regulatory agency interactions, addressing objections and negotiating outcomes.
  • Oversee project timelines, budgets, and deliverables, ensuring high-quality outcomes.
  • Mentor and manage team members, providing training and technical leadership.
  • Contribute to business development through client relationships and identifying new opportunities.

Requirements:

  • Senior Consultant: 8+ years in drug development and regulatory affairs.
  • Principal Consultant: 10+ years in drug development and regulatory affairs.
  • Proven experience with FDA, EMA, and/or MHRA processes, including submissions and negotiations.
  • Expertise in biologics, ATMPs, vaccines, or small molecules.
  • Advanced degree in life sciences (MSc or PhD preferred).
  • Strong leadership, organizational, and time management skills.

The estimated salary for this role is £80,000 - £110,000 per annum, depending on experience. Benefits include a flexible schedule, monthly office visits, and the opportunity to work with a dynamic and growing global consultancy.



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