Moderna is seeking a Senior Director, Global Regulatory Strategy, Oncology to lead development and execution of global regulatory strategy for programs in its oncology portfolio.
Requirements
- BA/BS degree in a scientific/engineering discipline
- 12+ years of experience in the Pharmaceutical industry
- 8+ years of experience in Regulatory strategy, including oncology
- Strong knowledge of current US and EU regulations
- Strong experience with CTD format and content regulatory filings
- Exceptional written and oral communication
- Experience with developing and implementing competitive regulatory strategies
- Demonstrated track record in securing product approvals and maintaining a complex portfolio
- Experience dealing with broad range of stakeholders at all levels internal and external to the company
- Demonstrated competence in employee management and development
- Knowledge of and broad experience with regulatory procedures and legislation for drug development, product registration, line extension and license maintenance
Benefits
- Best-in-class healthcare coverage
- A holistic approach to well-being, with access to fitness, mindfulness, and mental health support
- Family planning benefits, including fertility, adoption, and surrogacy support
- Generous paid time off
- Savings and investment opportunities to help you plan for the future
- Location-specific perks and extras