Associate Director Regulatory Affairs

Cpl Life Sciences
Hertfordshire
3 days ago
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Associate Director, Global Regulatory Strategy


Hertfordshire, UK – Hybrid (3 days per week on‑site)


Full-time | Permanent

Are you an experienced regulatory professional looking to shape global strategy and influence product development at an international level? This is an exciting opportunity to a global Pharmaceutical Manufacturing organisation as an Associate Director, Global Regulatory Strategy.


What You’ll Do

Regulatory Submissions (CTA/MAA)

  • Lead and participate in regulatory submission activities across assigned programs.
  • Review regulatory documents to ensure quality, compliance, and timely delivery.

Interfacing with Health Authorities

  • Serve as the primary point of contact with global regulatory authorities.
  • Lead authority interactions, including calls, meetings, and formal engagements.
  • Author Scientific Advice requests and guide cross‑functional teams on regulatory strategy.

Global Regulatory Strategy Development

  • Contribute to the development and execution of global regulatory strategies for assigned products.
  • Provide strategic insight for your functional area and region, influencing development pathways and regulatory planning.


You must have full RTW in the UK with no restrictions and be able to commute to the Hertfordshire site 3 times per week


If this is something you'd be interested in, apply using the link or send me a message -

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