Senior Director, Global Regulatory Strategy Lead - Regulatory Affairs
Olema Oncology
Full-time
Remote friendly (Cambridge, MA)
Worldwide
$275,000 - $290,000 USD yearly
Other
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Senior Director, Global Regulatory Strategy Lead - Regulatory Affairs
Company Name
Olema Oncology
Job Description
The Senior Director, Global Regulatory Strategy Lead - Regulatory Affairs will lead the development and execution of innovative regulatory strategies for Olema's products, including leading the NDA submission for the company's lead program. This role involves representing Regulatory Affairs on cross-functional teams, providing expert guidance, and leading the development of various regulatory submissions.
Responsibilities
- Managing health authority interactions
- Developing departmental policies
- Mentoring colleagues
Requirements
- Bachelor's degree in a scientific discipline
- At least 12 years of Regulatory Affairs experience in Pharma/Biotech
- 3+ years in leadership
- Strong knowledge of global regulatory requirements, particularly in Oncology