Job Summary
The Associate Director will oversee the formulation of global regulatory strategies and the daily regulatory operations for oncology clinical trials. This position entails acting as the main point of contact with the FDA and directing cross-functional teams to facilitate the preparation of regulatory submissions and meetings with health authorities.
Responsibilities
- Manage global regulatory strategies and oversee day-to-day regulatory activities for oncology clinical studies.
- Act as the primary liaison with the FDA.
- Lead cross-functional teams in the preparation of regulatory submissions.
- Coordinate health authority meetings and ensure compliance with regulations.
Qualifications
- Bachelor’s degree in a biological science.
- Minimum of 5 years of experience in regulatory affairs within the pharmaceutical industry.
- In-depth knowledge of US FDA and international regulations.
- Expertise in clinical development processes.
Summit Therapeutics provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
