Senior Director, Global Regulatory Strategy Lead - Regulatory Affairs

Role Summary

The Senior Director, Global Regulatory Strategy Lead - Regulatory Affairs reports to the Senior Vice President of Regulatory Affairs and leads the development and execution of regulatory strategies to advance Olema's lead and portfolio programs. The role includes guiding global regulatory submissions, representing Regulatory Affairs on cross-functional teams, and ensuring compliance with health authority requirements across development and life-cycle management. The position is based in Boston, MA or San Francisco, CA and requires domestic and international travel up to 20%.

Responsibilities

• Lead the development of the New Drug Application (NDA) and lead the development and submission of regulatory filings (INDs, CTX, briefing documents, IB, NDA, BLA, DMF, IMPD, etc.).
• Develop and execute innovative regulatory strategies supporting Olema products and provide regulatory guidance to global project teams, Study Execution Teams, and the Executive Committee.
• Represent Regulatory Affairs on cross-functional teams as the subject matter expert and ensure regulatory guidance and oversight across programs.
• Stay abreast of regulatory landscapes and requirements impacting drugs, biologics, and devices; interact with Global Health Authorities 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 HA reporting schedules with cross-functional teams.
• Lead the development of Regulatory Affairs department policies, SOPs, and work instructions; guide software implementations for regulatory dossiers (e.g., Veeva); keep leadership informed of regulatory landscape and HA initiatives.
• Lead and develop global regulatory teams to execute regulatory strategies; mentor and develop other regulatory colleagues; support SVP Regulatory Affairs as required.

Qualifications

• Knowledge
  • Bachelor’s degree in a scientific discipline; Advanced degree (Masters, PharmD, or PhD) preferred.
• Experience
  • Minimum of 12 years of experience in Regulatory Affairs in Pharma/Biotech.
  • Minimum of 3 years direct leadership experience.
  • Experience with development and execution of regulatory strategies in Oncology is strongly preferred.
  • Strong understanding of US FDA, EU and international regulatory guidance, drug development process, and industry standards.
  • Experience with major regulatory submissions (NDA/NDS/MAA) is required; ability to negotiate with Health Authorities and lead internal teams on regulatory strategy.
  • Ability to work in a fast-paced, hands-on environment; excellent oral, written, and presentation skills; experience presenting to leadership teams.
  • Proficiency in cross-functional collaboration and global regulatory team representation.
  • Strong planning and organizational skills; ability to manage multiple projects with tight timelines; experience across all development phases and post-marketing activities is highly preferred.
  • Demonstrated ability to analyze and interpret efficacy and safety data; strong understanding of regulatory operational activities.
• Attributes
  • Self-starter; flexible and proactive; able to manage multiple projects and adapt to changing priorities.
  • Team player.

Skills

• Excellent oral, written, and presentation skills; experience communicating with leadership.
• Strong regulatory problem-solving and negotiation abilities with Health Authorities.
• Strategic thinking with hands-on execution capability in a fast-paced environment.
• Leadership and mentorship of regulatory colleagues; cross-functional collaboration.

Education

• Bachelor’s degree in a scientific discipline; Master’s, PharmD, or PhD preferred.

Additional Requirements

• Travel up to 20% (domestic and international).