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Regulatory Affairs Director

2 months ago

London, Greater London, United Kingdom Lifelancer Full time
Job Title: Associate Director Global Regulatory Affairs

The Associate Director Global Regulatory Affairs is a critical role responsible for ensuring regulatory objectives are met and aligned with Telix's corporate goals. This position plays a key part in developing and executing global regulatory strategies and dossier compliance for assigned products.

Key Responsibilities:
  • Develop and execute global regulatory strategies and submission requirements in collaboration with the regulatory affairs team.
  • Represent regulatory affairs on project teams, providing guidance and regulatory expertise to other departments to support product development.
  • Lead regulatory agency interactions, including coordination of briefing package preparation, meeting minutes, and responses to agency questions.
  • Prepare, review, and analyze pharmaceutical and technical information for regulatory submissions to health authorities.
  • Provide regulatory assessments for change management and ensure compliance of regulatory submissions by filing and/or coordinating regulatory amendments.
  • Monitor global health authority regulations, guidelines, and specifications to maintain regulatory submission compliance.
  • Lead regulatory interactions with health authorities for IND and BLA filings.
Requirements:
  • Undergraduate degree in a scientific field (chemistry, biology, pharmaceutical sciences) required; advanced degree preferred.
  • 7 years of experience in regulatory affairs for pharmaceutical products.
  • Direct experience in writing regulatory sections for global health authority applications.
  • Direct experience in radiopharmaceuticals, biologicals, and/or clinical preferred.
  • Comprehensive knowledge of drug development processes, biopharmaceutical technology, drug manufacturing processes, GMP, and related issues.
  • Ability to understand and interpret regional regulations, guidance documents, and common and scientific publications.
  • Experience working globally in the US and EMEA.

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