Associate Director of Regulatory Affairs

Location Essex
Discipline: Regulatory Affairs
Job type: Permanent
Salary: ££80,000 - £85,000 DOE plus benefits
Contact name: Katie Dunbar

Contact email:
Contact phone: +44 1293 584 300
Job ref: 27718
Published: 11 days ago
Expiry date: 25 Jun 2023 11:59
A leading name in the global biopharma industry are seeking an Associate Director to join their UK & Ireland Regulatory Affairs team.

With ownership of Marketing Authorisation submissions, product launch and lifecycle management, this is a role which will see you flexing all your Regulatory Affairs muscles!  

If successful in this role, you will be responsible for developing and implementing strategy for the full portfolio of products, including Generic and Innovative drugs (both prescription and OTC), Medical Devices and combination products.

Interacting with stakeholders across all other business functions, you will lead your team to deliver on your innovative strategies and leverage your strong Health Authority relationships to ensure successful submissions. Reporting to the Head of Regulatory Affairs, this highly visible role is a real chance to shine, with impressive progression opportunities available.

Essential Experience:
  • Relevant Life Sciences degree
  • Previous experience of team management of including accountability for projects, ownership of team structure and line management
  • Innovative regulatory strategy development
  • Substantial new submission and post approval submission experience for a wide range of dosage forms including generics, NCEs, devices and OTC products.
  • A working knowledge of CTAs, PIPs and ODDs.
  • Experience building strong relationships and leading post-Brexit MHRA and HPRA interactions.
  • Experience in leading and chairing Scientific Advice meetings.

This role is based on-site in Essex two days per week, with 3 days from home. The salary is negotiable and competitive, with a benefits package including bonus, enhanced pension, personal and family medical, life insurance, and a generous holiday allowance with the option to buy more.

If you’d like to find out more, please apply with your CV and I will be in contact with more information. 01273 952176