Position Overview:
The Senior Director, Global Regulatory Strategy Lead will be responsible for leading global regulatory strategy and major submissions (especially NDA) for Olema’s oncology programs. Reporting to the SVP of Regulatory Affairs, this leadership role will guide regulatory planning, submissions, agency interactions, and cross-functional alignment throughout the product lifecycle.
Key Responsibilities:
- Lead development and submission of New Drug Applications (NDAs) for Olema’s lead program.
- Develop and execute global regulatory strategies across clinical development and life-cycle management.
- Represent Regulatory Affairs in cross-functional teams and executive meetings.
- Lead global Health Authority (HA) interactions and negotiations.
- Guide preparation of regulatory submissions (INDs, CTAs, NDAs, BLAs, etc.).
- Identify risks and develop mitigation strategies.
- Ensure compliance with HA requirements and manage submission timelines.
- Mentor and manage regulatory team members.
- Develop departmental SOPs and regulatory infrastructure (e.g., software systems like Veeva).
Candidate Profile:
Education:
- Bachelor's in a scientific field (required).
- Advanced degree (PharmD, PhD, or MS) preferred.
Experience:
- 12+ years in Regulatory Affairs in pharma/biotech.
- 3+ years of leadership experience.
- Strong oncology background and regulatory strategy experience.
- Experience with major submissions (e.g., NDA, MAA), regulatory negotiations, and agency interactions.
- Proficiency in U.S., EU, and international regulatory requirements.
- Experience across all phases of development, including post-marketing.
Skills & Attributes:
- Strong strategic thinking and leadership skills.
- Excellent communication, organization, and cross-functional collaboration.
- Hands-on, adaptable, proactive, and a strong team player.
- Willingness to work on-site at least 2 days/week.
- Able to travel up to 20% (domestic/international).
Compensation:
- Base salary: $275,000 – $290,000/year
- Additional: Equity, bonus, and benefits
Job sourced from Olema Oncology.