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 supporting Olema products, oversee regulatory submissions, and guide cross-functional teams on regulatory affairs. 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 development and submission of the NDA for the company's lead program.
• Stay abreast of the regulatory landscape and regulatory requirements impacting drugs, biologics and devices.
• Represent Regulatory Affairs on cross-functional teams as the SME 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.).
• Represent Olema with Global Health Authorities and lead Agency interactions to achieve company objectives.
• Identify gaps and develop risk mitigation strategies for the regulatory submissions.
• 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 the regulatory landscape, including HA initiatives and impact on Olema‚Äôs programs.
• Lead the global regulatory team(s) and ensure execution of the Regulatory strategies to achieve company objectives.
• Mentor and develop other regulatory colleagues in the department.
• Support SVP Regulatory Affairs, as required.

Qualifications

• Knowledge:
  • Bachelor‚Äôs degree in a scientific discipline.
  • Advanced degree in scientific discipline (Masters, Pharm D or PhD) preferred.
• Experience:
  • At least 12 years‚Äô 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, drug development process, and industry standard practices.
  • 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 environment in a hands-on fashion.
  • Excellent oral, written, and presentation skills, with experience presenting to leadership teams.
  • Proficiency in organizational awareness and cross-functional collaboration on 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 the ability to manage multiple projects and adapt to changing business needs.
  • Team player.
  • On-site presence at headquarters required (minimum 2 days a week).

Education

• Bachelor‚Äôs degree in a scientific discipline.
• Masters, Pharm D or PhD preferred.

Skills

• Regulatory strategy development
• IND/NDA/BLA/MAA submissions
• Global health authority interactions
• Cross-functional leadership
• Regulatory operations and submissions management
• Regulatory landscape monitoring
• Software systems for regulatory dossiers (e.g., Veeva)
• Communication and presentation to leadership