Senior Director, Global Regulatory Strategy Lead - Regulatory Affairs

Role Summary

Senior Director, Global Regulatory Strategy Lead - Regulatory Affairs. Lead the development and execution of innovative regulatory strategies for Olema products, oversee regulatory submissions, and provide regulatory guidance to global project teams. 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 development and submission of NDA for the company’s lead program.
• Develop innovative global regulatory strategies for the portfolio, in clinical development and lifecycle management.
• Represent Regulatory Affairs on cross-functional teams as SME and oversee regulatory guidance to global project teams, Study Execution Teams, and the Executive Committee.
• Stay abreast of regulatory landscape and requirements impacting drugs, biologics, and devices.
• Represent Olema with Global Health Authorities and lead Agency interactions.
• Identify gaps and develop risk mitigation strategies for regulatory submissions.
• Ensure regulatory activities are robust and in compliance with Health Authority requirements; coordinate HA reporting schedules 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 regulatory software implementations (e.g., Veeva).
• Keep leadership informed of regulatory landscape, HA initiatives, and impact on Olema’s programs.
• Lead the global regulatory teams and ensure execution of regulatory strategies to achieve company objectives.
• Mentor and develop other regulatory colleagues; 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’ 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 guidelines, regulations, drug development process.
  • 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; experience presenting to leadership.
  • Proficiency in cross-functional collaboration and global teams.
  • 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.
  • Demonstrated ability to analyze and interpret efficacy and safety data.
  • Strong understanding of regulatory operational activities.
• Attributes:
  • Self-starter.
  • Flexible and proactive, with ability to manage multiple projects and adapt to changing priorities.
  • Team player.
  • On-site presence at headquarters required (minimum 2 days a week).

Education

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

Additional Requirements

• Willingness to travel domestically and internationally up to 20%.