Regulatory Affairs Director Job at Virtual Vocations Inc, United States

  • Virtual Vocations Inc
  • United States

Job Description

Leading the regulatory function for clinical-stage radiopharmaceutical programs, the full-time salaried Head of Regulatory Affairs will define global regulatory strategy, manage key submissions, and engage with health authorities while working remotely. Key Responsibilities Define and lead global regulatory strategy for clinical-stage radiopharmaceutical programs Lead key regulatory submissions, including INDs, CTAs, and DMFs Serve as the primary point of contact for regulatory agencies and build strong relationships with key regulatory authorities Required Qualifications Advanced degree (JD, PhD, PharmD, MD or equivalent) in a scientific discipline is preferred 15+ years of regulatory affairs experience in the biotech or pharmaceutical industries In-depth knowledge of global regulatory requirements and guidelines, including FDA and EMA regulations Proven track record of successful regulatory submissions, including INDs, NDAs, and BLAs Experience leading regulatory affairs strategies for complex programs across multiple therapeutic areas

Job Tags

Full time, Remote work

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