Executive Regulatory Science & Strategy Director, Oncology
$276,000–$414,000 year
Hybrid · Gaithersburg, Maryland, United States
Job Summary
Executive Regulatory Science Director role within Oncology Regulatory Affairs overseeing the Oncology Breast Cancer portfolio. Provides global strategic regulatory expertise to support research, development and commercialization of products across small molecules and biologics. Responsibilities include coaching and mentoring regional and global regulatory leads, aligning with Regulatory Affairs Directors on global innovative strategies, leading resource planning and staff recruitment, reviewing and approving high-level documents for global regulatory submissions and core prescribing information, ensuring submission excellence, sponsoring key non-drug workstreams and acting as a subject matter expert, and advising senior management on regulatory risks and mitigations. Requires a Bachelor’s degree (advanced degrees asset), 10+ years of drug development experience in oncology, strong leadership in matrixed settings, and ability to travel globally. This position is based in the US with a hybrid office pattern (3 days in office per week) and involves cross-regional collaboration and governance participation.
Required Qualifications
- Bachelor’s degree in life sciences and/or science related field and/or other appropriate knowledge/experience
- MSc, PhD, PharmD, MD is a definite asset
- More than 10 years drug development experience
- Oncology therapy area knowledge/experience, ideally expertise with breast tumor types
- Deep knowledge of global regulatory strategy experience with all phases of oncology drug development, including early drug development as well as direct involvement in marketing applications that have progressed through to registration
- Significant experience in leading major health Authority interactions
- Proven experience of growing high performance teams, attracting top talent, and developing capabilities of regional and global regulatory leads
- Experience in leading people in a matrixed interpersonal structure
- Ability to think strategically and critically to evaluate risks to regulatory product development and approval, market entry and license maintenance activities
- Ability to travel domestically and internationally
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