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Job Details

Head of Regulatory Affairs - Niche Biotech - UK Based

Company: Barrington James Europe
Location: UK
Reference: em-headofra
Closing Date: 05 Apr 18
Type: Permanent
Salary (£): 100,000+
Benefits: Competitive

Job Summary:

Head of Regulatory Affairs - Niche Biotech - UK Based


Company: Biotech

Location: TBC

Salary: £150,000 + package



My team and I are in partnership with an exciting biopharmaceutical company that are looking to expand their Global Regulatory Affairs team. Following a successful meeting with the CMO, my team and I have been assigned to find this truly innovative company a ‘Head of Regulatory Affairs’ to be based in the UK. Our client has 2 products entering Phase II and 2 products going into clinical development. This is an opportunity to build and manage the Regulatory Affairs and oversee the Quality Assurance functions for the company on a global basis.

If you are looking to make a move away from a large company, then this company could be the one for you. Due to the exposure to board members and C suite level professionals, you will have the capabilities and power to make real changes to the companies vision and portfolio.

Key Areas of Responsibility

  • Develop and implement innovative regulatory strategies for products entering and in clinical development
  • Act as a point person for regulatory agency interactions, including preparation of submissions and regulatory strategy planning
  • Supervise the Quality Assurance aspects of the company’s internal and external manufacturing activities
  • Managing timelines, resource, budgets and risks and reporting on progress for Regulatory and Quality activities
  • Work closely with the Clinical, Manufacturing and Project Management functions to ensure smooth overall clinical development programme execution


Experience / Qualifications Required


  • Advanced degree in a scientific discipline
  • At least 8 years’ experience in regulatory roles in a pharmaceutical or biotech setting
  • Experience working directly with MHRA and EMA required (FDA also preferred)
  • Previous IND and NDA submission experience preferred
  • Entrepreneurial attitude to identify expedited clinical development pathways a must
  • Ability to work effectively and independently to fast-moving timelines within a fast-paced working environment
  • A flexible and collaborative nature


For more information, please reach out to me directly:

+44 1293 77 66 44

Apply for this job: Head of Regulatory Affairs - Niche Biotech - UK Based

Contact Information:

Address:  Head Office
Rowan House Smallfield Road Horley Surrey
Tel:  01293 776644
Fax:  01293 822333
Website:  Visit Our Web Site

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