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Associate Director Regulatory Affairs

3 months ago

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.


Is your CV ready If so, and you are confident this is the role for you, make sure to apply asap.

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.