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Director, US Regulatory Lead

Job description

Director, US Regulatory Lead 
East Coast – United States

We are seeking an experienced Regulatory Affairs Leader to serve as the US regulatory lead for early and late-stage development projects, with a primary focus on upcoming NDA submissions within the radiopharmaceutical space. This role will be the main point of contact for FDA interactions, ensuring compliance with US regulatory requirements while providing strategic guidance across CMC, nonclinical, clinical, labeling, and procedural aspects. This role is an opportunity to shape regulatory strategy and execution for cutting-edge radiopharmaceuticals, working in a highly collaborative and forward-thinking organization.

  • Act as the Regulatory Affairs expert for US regulatory requirements.
  • Serve as FDA liaison, leading regulatory interactions and submission strategies.
  • Drive planning, preparation, and execution of NDA and IND submissions.
  • Provide regulatory guidance across development stages and lead FDA meetings (Pre-IND, Pre-NDA, Type A-D).
  • Oversee submission planning, risk mitigation, and lifecycle management of complex radiopharmaceutical products.
  • Author and review high-quality regulatory documents for FDA submissions (e.g., meeting requests, briefing books, iPSPs, orphan annual reports) to ensure compliance with US regulatory requirements.
  • Collaborate with cross-functional teams, including clinical, regulatory, marketing, and commercial groups.

Requirements

  • Bachelor’s or Master’s degree in pharmacy, chemistry, biochemistry, biotechnology, or a related field (post-graduate degree preferred).
  • 10+ years of regulatory affairs experience in the pharmaceutical or biotech industry.
  • In-depth knowledge of US regulatory requirements for pharmaceuticals and extensive experience in direct FDA interactions.
  • Experience with radiopharmaceuticals is a plus.
  • Proven expertise as an FDA liaison in IND/NDA regulations and US product development and registration requirements.
  • Strong ability to work independently while also excelling as a team player in a collaborative environment.
  • Excellent communication, negotiation, and problem-solving skills, with a proactive and strategic approach.