Associate Director Regulatory Affairs

7 days ago

Greater London, United Kingdom Blackfield Associates Full time

Our client, an international pharmaceutical company, has a requirement for a highly experienced Regulatory professional join their London based team, leading the Digital health and Precision Medicine strategy.


As Associate Director, Global Regulatory Affairs Strategy, you will be responsible for:

  • Lead the global regulatory strategy for biomarkers, companion diagnostic tests, digital health, and other devices, enhancing the value of our pharmaceutical products across various therapeutic areas.
  • Participate in developing target labelling
  • Provide input into protocol synopses and protocols and contribute to rapid response teams addressing Clinical Trial Application (CTA) queries.
  • Understand the regulatory landscape, assess regulatory risks, and develop global filing strategies.
  • Co-lead marketing application submission teams for indications at the regulatory filing stage, developing content strategies for global dossiers.
  • Ensure consistent responses to global Health Authority (HA) queries.
  • Align global development plans with regulatory requirements by integrating regional regulatory strategy liaison input.
  • Develop global submission plans and HA interaction plans in collaboration with the Global Regulatory sub-team.


To be considered as the Associate Director, Global Regulatory Affairs Strategy, you will have the following:

  • Educated to degree level- advanced scientific degree preferred (Masters, PhD, PharmD)
  • Minimum 7 years Regulatory experience, with 4+ years in industry / US Medical Device
  • Experience with CTA's in drug trials, facilitating communication between diagnostic and drug sponsors.
  • Proven leadership experience, capable of representing regulatory functions on project teams within the company and across alliances.
  • Effective communication of regulatory strategies, issues, and risks to governing bodies, both written and verbally.
  • Active participation in Global Regulatory sub-teams or similar industry experience.
  • Strong decision-making skills, task prioritization, and organizational abilities
  • Familiarity with the R&D process and specific regulatory responsibilities/deliverables for company decision points.

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