Senior Director, Global Regulatory Strategy Lead - Regulatory Affairs

Role Summary

Senior Director, Global Regulatory Strategy Lead - Regulatory Affairs. Lead development and execution of innovative regulatory strategies to support Olema products, manage cross-functional regulatory activities, and oversee regulatory submissions across the product lifecycle. Based in Boston, MA or San Francisco, CA with travel up to 20%.

Responsibilities

• Lead the development of the New Drug Application (NDA).
• Lead the development and execution of innovative regulatory strategies supporting Olema products.
• Represent Regulatory Affairs on cross-functional teams as the subject matter expert and provide regulatory guidance and oversight to the global project teams, Study Execution Teams, and the Executive Committee.
• Provide strategic and tactical guidance and lead the development of regulatory submissions (INDs, CTX, briefing documents, IB, NDA, BLA, DMF, IMPD, etc.).
• Lead the NDA development and submission for the company's lead program.
• 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 regulatory requirements.
• Coordinate and maintain all HA reporting schedules in collaboration with cross-functional teams.
• Be flexible to adapt and accommodate additional duties as assigned.
• Lead the development of 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 regulatory landscape and HA initiatives and their impact on Olema’s programs.
• Lead the global regulatory team(s) and ensure execution of regulatory strategies to achieve company objectives.
• Mentor and develop other regulatory colleagues in the department; support SVP Regulatory Affairs as required.

Qualifications

• Knowledge:
  • Bachelor’s degree in a scientific discipline.
  • Advanced degree in scientific discipline (Masters, PharmD or PhD) preferred.
• Experience:
  • At least 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 pharmaceutical guidance, regulations, and drug development processes.
  • Experience with major regulatory submissions (NDA/NDS/MAA) is a must.
  • Experience in strategic problem-solving and negotiation with Health Authorities and leading internal teams on regulatory strategy.
  • Ability to work in a fast-paced, hands-on environment; excellent oral, written, and presentation skills.
  • Demonstrated cross-functional collaboration and global team experience.
  • Excellent planning and organizational skills; ability to manage multiple projects with tight timelines.
  • Experience in all phases of development and post-marketing activities is highly preferred.
  • Ability to analyze and interpret efficacy and safety data; strong regulatory operations understanding.
• Attributes:
  • Self-starter.
  • Flexible and proactive, able to manage multiple projects and adapt to changing priorities.
  • Team player; on-site presence at headquarters required (minimum 2 days a week).

Skills

• Regulatory strategy development and execution
• Global Health Authority interactions
• Regulatory submissions management (INDs, NDA/BLA, DMF, IMPD, etc.)
• Cross-functional leadership and mentoring
• Regulatory operations and dossier management (including software systems)
• Strategic problem solving and negotiation

Education

• Bachelor’s degree in a scientific discipline; advanced degree preferred.