Senior Regulatory Consultant

1 week ago


London, Greater London, United Kingdom Barrington James Full time
Job Title: Senior Regulatory Consultant

Barrington James is seeking an experienced regulatory professional to lead our CMC strategy. This senior role is based in London, United Kingdom, with a flexible schedule and monthly office visits.

Salary: £85,000 - £115,000 per annum

Job Description:
In this role, you will provide expert regulatory advice to clients, focusing on CMC aspects of product development. You will lead regulatory submissions, guide multi-jurisdictional projects, and manage client relationships. Additionally, you will play a key role in mentoring junior team members and contributing to business development efforts.

Main Responsibilities:
  • Develop cutting-edge CMC regulatory strategies, gap analyses, and drug development plans.
  • Author and review regulatory documents (INDs, IMPDs, MAAs, etc.), ensuring accuracy and compliance.
  • Represent clients in regulatory agency interactions, driving successful outcomes and building strong relationships.
  • Manage project timelines, budgets, and deliverables, guaranteeing high-quality results.
  • Mentor and develop junior team members, providing technical guidance and supporting their growth.
  • Contribute to business development efforts, identifying opportunities and driving revenue growth.

Requirements:
  • 8+ 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.
  • Willingness to travel occasionally and work flexible hours.


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