Head of Regulatory Affairs (Oncology)
Head of Regulatory Affairs (Oncology)
Discover International
United States
See who Discover International has hired for this role
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
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Seniority level
Executive -
Employment type
Full-time -
Job function
Other and Science -
Industries
Biotechnology Research and Pharmaceutical Manufacturing
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