Regulatory Affairs Senior Director

This clinical-stage oncology company is developing the next generation of treatments for various types of cancers.  They are seeking a Senior Director of Regulatory Affairs to develop and execute on regulatory strategies for their pipeline of novel programs. As their first regulatory hire, you will serve as the primary interface with the FDA while building the regulatory function and SOPs. This company offers competitive compensation, great benefits, and a patient-focused culture.  Now is an exciting time to join this growing organization and help to get innovative oncology programs approved! 

Responsibilities:

  • Serve as sole regulatory person for the company, developing and executing regulatory strategies for novel oncology programs.
  • Manage all clinical, non-clinical and CMC regulatory activities.
  • Write, review and submit regulatory filings to health authorities including INDs, clinical trial applications, amendments, meeting briefing documents, DSURs, and orphan drug applications.
  • Serve as the primary point of contact for all FDA interactions.
  • Prepare and review clinical protocols, investigator brochures, informed consents, and other GCP documentation with internal teams
  • Help establish and build internal SOPs and data capture systems

 

Qualifications:

  • Bachelors degree in a scientific discipline is required. Advanced degree such as MS, PhD or Pharm D preferred.
  • 8-10 years of regulatory affairs experience ideally in a small biotech environment.
  • Regulatory experience across all phases of development, especially in early stages.
  • Experience filing IND and CTA applications. Must have some experience with CMC regulatory filings including CMC sections and change controls.
  • Demonstrated project management skills with a track record of success.
  • Ability to work as an individual contributor but also able to hire and built out a regulatory team.
  • Must be able to thrive in a fast-paced biotech environment and work with internal teams and with external partners

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