Senior Director, Global Regulatory Strategy Lead - Regulatory Affairs

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; provide regulatory guidance and oversight to global project teams, Study Execution Teams, and the Executive Committee
- Provide strategic and tactical guidance; 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 (clinical development and life-cycle management)
- Stay abreast of the regulatory landscape and requirements impacting drugs, biologics, and devices
- Represent the company with Global Health Authorities; lead agency interactions to achieve company objectives
- Identify gaps and develop risk mitigation strategies for regulatory submissions
- Ensure regulatory activities are robust and compliant with Health Authority requirements
- Coordinate and maintain HA reporting schedules with cross-functional teams
- Lead Regulatory Affairs department policies, SOPs, and work instructions
- Provide regulatory guidance and leadership to cross-functional teams on software implementation for regulatory dossiers (e.g., Veeva)
- Keep leadership informed of the regulatory landscape, including HA initiatives and their impact
- Lead global regulatory team(s) and ensure execution of regulatory strategies
- Mentor and develop regulatory colleagues
- Support SVP Regulatory Affairs, as required

Qualifications (Knowledge/Experience):
- Bachelor’s degree in a scientific discipline
- Advanced degree (Master’s, PharmD, or PhD) preferred
- Minimum 12 years’ Regulatory Affairs experience in Pharma/Biotech
- Minimum 3 years of direct leadership experience
- Oncology therapeutic area regulatory strategy experience strongly preferred
- Strong understanding of US FDA, EU, and international pharmaceutical guidance, regulations, drug development process, and industry practices
- Experience with major regulatory submissions (NDA/NDS/MAA) is required
- Experience negotiating with Health Authorities and leading internal teams on regulatory strategy is required
- Hands-on ability to work in a fast-paced environment
- Excellent oral, written, and presentation skills
- Cross-functional and global team experience representing Regulatory Affairs
- Strong planning/organizational skills; ability to manage multiple projects with tight timelines
- Experience across all phases of development and post-marketing activities highly preferred
- Ability to analyze and interpret efficacy and safety data
- Strong understanding of regulatory operational activities

Attributes:
- Self-starter
- Flexible and proactive; can manage multiple projects and adapt to changing priorities
- Team player

Work Location/Travel:
- Based in Boston, MA or San Francisco, CA
- Domestic and international travel up to 20%

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

Application Instructions:
- Olema doesn’t accept agency resumes.