Senior Director, Global Regulatory Strategy Lead - Regulatory Affairs

Responsibilities:
- Lead the development of the New Drug Application (NDA).
- Lead the development and execution of innovative regulatory strategies supporting Olema products.
- Serve as Regulatory Affairs subject matter expert on cross-functional teams, providing 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 Olema portfolio across clinical development and life-cycle management.
- Stay abreast of the regulatory landscape and requirements impacting drugs, biologics, and devices.
- Represent Olema with Global Health Authorities and lead agency interactions to achieve company objectives.
- Identify gaps and develop risk mitigation strategies for regulatory submissions; ensure compliance with Health Authority requirements.
- Coordinate and maintain Health Authority reporting schedules with cross-functional teams.
- Be flexible to accommodate additional duties as assigned.
- Lead Regulatory Affairs department policies, SOPs, and work instructions.
- Provide regulatory guidance on software implementation for regulatory dossiers (e.g., Veeva).
- Keep leadership fully informed of the regulatory landscape, including Health Authority initiatives and impact on programs.
- Lead global regulatory team(s) and ensure execution of regulatory strategies.
- Mentor and develop Regulatory colleagues; support SVP Regulatory Affairs as required.

Qualifications / Required skills:
- Bachelor’s degree in a scientific discipline.
- Minimum 12 years’ experience in Regulatory Affairs in Pharma/Biotech.
- Minimum 3 years’ direct leadership experience.
- 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)).
- Experience in strategic problem-solving and negotiation with Health Authorities and leading internal teams on regulatory strategy.
- Excellent oral, written, and presentation skills; experience presenting to leadership.
- Demonstrated cross-functional and global team experience representing Regulatory Affairs.
- Excellent planning/organizational skills; ability to manage multiple projects with tight timelines.
- Ability to analyze and interpret efficacy and safety data.
- Strong understanding of regulatory operational activities.
- Ability to work in a fast-paced environment in a hands-on fashion.
- Willingness to travel domestically and internationally up to 20%.

Preferred qualifications:
- Advanced degree in a scientific discipline (MS, PharmD, or PhD).
- Experience with regulatory strategies in Oncology therapeutic area.
- Experience in all phases of development and post-marketing activities.

Compensation / benefits:
- Base pay range: $275,000–$290,000 annually; total compensation includes equity, bonus, and benefits.

Application instructions:
- Please note: Olema doesn’t accept agency resumes.