Head of Regulatory Affairs (Oncology)

Position Summary: Lead the Regulatory Affairs function, developing and executing regulatory strategies for the entire portfolio. This role offers an opportunity to build and lead a team in a fast-paced, growing biotech company.

Responsibilities:

Develop and implement regulatory strategies for product approval and commercialization.

Oversee regulatory filings (INDs, NDAs) and ensure compliance with global regulatory requirements.

Collaborate with cross-functional teams to align and execute regulatory strategies.

Serve as the primary liaison with regulatory agencies.

Monitor and interpret regulatory developments.

Qualifications:

MS, PharmD or PhD

Over 15 years of Regulatory experience (primarily in Oncology)

Experience in preparing NDA/BLA submissions