Regulatory Affairs Director or Associate Director

My client is boldly advancing a deep pipeline of highly targeted therapies against previously unaddressed drivers of disease, allowing patients to live longer with better quality of life. They are seeking a Regulatory Affairs Associate Director or Director to develop and lead global regulatory strategies while advancing the company’s oncology portfolio. Reporting to the Head of Regulatory Affairs, you will interact directly with global health authorities and oversee relevant submissions. This is a great opportunity to join a fast-moving company where you can learn and grow.

 

Responsibilities:

  • Lead global regulatory strategies and execution for two key oncology programs.
  • Ensure effective communication and constructive working relationships with US and global regulatory authorities.
  • Oversee all relevant applications and submissions for assigned programs.
  • Sit on multiple core teams representing regulatory affairs.
  • Prepare for and lead critical meetings with the FDA
  • Provide oversight and guidance to external programs vendors and consultants

 

Knowledge and Skills:

  • Minimum BA required, advanced degree preferred
  • A minimum of 8 years of pharmaceutical industry experience, with at least 7+ years of regulatory experience
  • Must have filed INDs, CTAs, and/or NDA/BLAs to FDA and ex-US regulatory agencies
  • Experience in managing multiple global programs/filings required
  • Solid working knowledge of drug development process and US regulatory requirements required; knowledge of EU, Canada, ROW, and post-marketing regulatory requirements a plus
  • Experience in oncology drug development preferred

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