Senior Director, Global Regulatory Strategy Lead - Regulatory Affairs

Role Summary

Senior Director, Global Regulatory Strategy Lead – Regulatory Affairs, responsible for leading regulatory strategy development and execution for Olema’s product portfolio. Provides strategic guidance on submissions (INDs, NDA/BLA/MAA, DMF, IMPD, briefing documents, etc.), represents Regulatory Affairs on cross-functional teams, and leads global interactions with health authorities. Location options include Boston, MA or San Francisco, CA, with travel up to 20%.

Responsibilities

• Lead the development of the New Drug Application (NDA) and other regulatory submissions (INDs, CTX, briefing documents, IB, NDA, BLA, DMF, IMPD, etc.).
• Develop and execute innovative regulatory strategies supporting Olema products.
• Represent Regulatory Affairs on cross-functional teams as the subject matter expert; provide regulatory guidance to global project teams, Study Execution Teams, and the Executive Committee.
• Provide strategic and tactical guidance for regulatory submissions and lead agency interactions to achieve company objectives.
• Develop regulatory submissions, stay abreast of regulatory requirements for drugs, biologics, and devices, and identify risk gaps with mitigation plans.
• Coordinate regulatory reporting schedules with cross-functional teams and ensure compliance with health authority requirements.
• Lead the development of Regulatory Affairs department policies, SOPs, and work instructions; mentor regulatory colleagues; provide leadership on software implementations for Regulatory dossiers (e.g., Veeva).
• Keep leadership informed of regulatory landscape and HA initiatives; lead global regulatory teams to execute regulatory strategies.
• Support the SVP of Regulatory Affairs as required.

Qualifications

• Knowledge:
  • Bachelor’s degree in a scientific discipline
  • Advanced degree (Masters, PharmD, or PhD) preferred
• Experience:
  • Minimum 12 years in Regulatory Affairs in Pharma/Biotech
  • Minimum 3 years direct leadership experience
  • Experience with development and execution of regulatory strategies in Oncology; strong understanding of US FDA, EU, and international guidance and drug development processes
  • Experience with major regulatory submissions (NDA/NDS/MAA) required
  • Experience solving regulatory strategy problems and negotiating with Health Authorities; ability to lead cross-functional teams
  • Ability to work in a fast-paced environment; excellent oral, written, and presentation skills; proven cross-functional collaboration
  • Experience across all development phases and post-marketing activities preferred
  • Strong ability to analyze and interpret efficacy and safety data; solid regulatory operations understanding
• Attributes:
  • Self-starter; flexible and proactive; able to manage multiple projects
  • Team player; on-site presence at headquarters required (minimum 2 days a week)

Skills

• Strategic regulatory leadership for oncology portfolios
• Regulatory submissions strategy development (INDs, NDAs, BLA, MAA, etc.)
• Cross-functional leadership and stakeholder management
• Agency interactions and negotiation
• Regulatory forecasting, risk assessment, and lifecycle management
• Regulatory operations and dossier management (e.g., Veeva)
• Strong communication and presentation to leadership teams

Education

• Bachelor’s degree in a scientific discipline
• Advanced degree in scientific discipline (Masters, PharmD, or PhD) preferred

Additional Requirements

• On-site presence at headquarters required (minimum 2 days a week)
• Domestic and international travel up to 20%