Senior Director, Global Regulatory Strategy Lead - Regulatory Affairs

Responsibilities:
- Lead the development of the New Drug Application (NDA).
- Develop and execute innovative regulatory strategies supporting Olema products.
- Serve as subject matter expert for Regulatory Affairs on cross-functional teams; provide regulatory guidance and oversight to global project teams, Study Execution Teams, and the Executive Committee.
- Provide strategic and tactical guidance and lead development of regulatory submissions (INDs, CTX, briefing documents, IB, NDA, BLA, DMF, IMPD, etc.).
- Develop and submit the NDA for the company’s lead program.
- Develop innovative global regulatory strategies for the portfolio across clinical development and life-cycle management.
- Stay abreast of regulatory landscape and requirements impacting drugs, biologics, and devices.
- Represent Olema with Global Health Authorities; lead agency interactions to achieve company objectives.
- Identify gaps and create risk mitigation strategies for regulatory submissions.
- Ensure regulatory activities are robust and compliant with Health Authority requirements.
- Coordinate and maintain Health Authority reporting schedules with cross-functional teams.
- Lead development of Regulatory Affairs department policies, SOPs, and work instructions.
- Provide Regulatory guidance and leadership on software implementation for regulatory dossiers (e.g., Veeva).
- Keep leadership informed of the regulatory landscape and Health Authority initiatives.
- Lead global regulatory team(s) and ensure execution of regulatory strategies.
- Mentor and develop regulatory colleagues; support SVP Regulatory Affairs as required.

Qualifications / Required & Preferred Skills:
- Bachelor’s degree in a scientific discipline; advanced degree (Master’s, PharmD, or PhD) preferred.
- Minimum 12 years’ experience in Regulatory Affairs in Pharma/Biotech.
- Minimum 3 years’ direct leadership experience.
- Strongly preferred: experience developing/executing regulatory strategies in Oncology.
- Strong understanding of US FDA, EU, and international guidance/regulations, drug development process, and industry practices.
- Must have experience with major regulatory submissions (e.g., NDA/NDS/MAA).
- Required: experience in strategic problem-solving and negotiation with Health Authorities and leading internal teams on regulatory strategy.
- Ability to work hands-on in a fast-paced environment; excellent oral/written/presentation skills.
- Demonstrated cross-functional and global teamwork/proficiency.
- Strong planning/organizational skills; ability to manage multiple projects with tight timelines.
- Highly preferred: experience across all development phases and post-marketing activities.
- Demonstrated ability to analyze and interpret efficacy and safety data.
- Strong understanding of regulatory operational activities.

Benefits (as stated):
- Base pay range: $275,000–$290,000 annually; total compensation includes equity, bonus, and benefits.

Application instructions:
- Not provided in the text.