Job Summary
The Executive Director or VP will be responsible for spearheading the global regulatory strategy for oncology initiatives, guiding the process from pre-IND stages through to commercialization and ongoing lifecycle management. This role will serve as the main point of contact with health authorities and will oversee the compilation and submission of essential regulatory documentation.
Responsibilities
- Lead the development and execution of global regulatory strategies for oncology programs.
- Act as the key liaison with regulatory agencies, ensuring all communications are effectively managed.
- Oversee the preparation and timely submission of critical regulatory documents.
- Ensure compliance with regulatory requirements throughout the product lifecycle.
Qualifications
- Bachelor’s degree required; advanced degree preferred.
- A minimum of 10 years of relevant experience in regulatory affairs within the pharmaceutical or biotech industries.
- Extensive knowledge of global regulatory strategies, particularly in oncology.
- Proven track record of successful interactions with the FDA and other health authorities.
