olema
Senior Director, Global Regulatory Strategy Lead - Regulatory Affairs
At a Glance
- Location
- San Francisco, California, United States
- Experience
- 12+ years
- Compensation
- is position is expected to be $275,000-$290,000 annually, however the base pa
- Posted
- 2026-03-03T19:45:08-05:00
Key Requirements
Domain Knowledge
- Biotech
- Marketing
- Pharmaceutical
- Regulatory
Benefits & Perks
ve compensation and benefits package , seeking to provide an open, flexible,
Requirements
12 years’ experience in Regulatory Affairs in Pharma/Biotech
Experience with development and execution of regulatory strategies in Oncology Therapeutic area is strongly
Strong understanding of US FDA, EU and international pharmaceutical guidance, regulations, drug development process, and industry standard practices
Experience with major regulatory submissions (e.g.
New Drug Applications (NDA/NDS/MAA), is a must
Experience in strategic problem-solving and negotiation with Health Authorities and leading internal teams on the regulatory strategy for a given product is required
Responsibilities
Senior Director, Global Regulatory Strategy Lead - Regulatory Affairs
reporting to the Senior Vice President of Regulatory Affairs, your responsibilities will include the following:
Lead the development of the New Drug Application (NDA)
Lead the development and execution of innovative regulatory strategies supporting Olema products
Represent Regulatory Affairs on cross-functional teams as the subject matter expert and provide regulatory guidance and oversight to the global project teams, Study Execution Teams, and the Executive Committee
Provide strategic and tactical guidance and lead the development of regulatory submissions (INDs, CTx, briefing documents, IB, NDA, BLA, DMF, IMPD etc.)
About the Company
Develop innovative global regulatory strategies for the Olema portfolio of products, in clinical development and life-cycle management, as needed
Represent Regulatory Affairs on cross-functional teams as the SME and provide regulatory guidance and oversight to the global project teams, Study Execution Teams, and the Executive committee
Stay abreast of the regulatory landscape and regulatory requirements impacting drugs, biologics and devices
Provide strategic and tactical guidance and lead the development of regulatory submissions (INDs, CTX, briefing documents, IB, NDA, BLA, DMF, IMPD etc.)
Represent Olema with Global Health Authorities and lead Agency interactions to achieve company objectives
Identify gaps and develop risk mitigation strategies for the regulatory submissions