Senior Director, Global Regulatory Strategy Lead - Regulatory Affairs

Role Summary

Senior Director, Global Regulatory Strategy Lead - Regulatory Affairs. Lead the development of regulatory strategies and submissions for Olema's portfolio, represent Regulatory Affairs on cross-functional teams, and guide global regulatory activities to support development and lifecycle management of Olema products.

Responsibilities

• Lead the development of the New Drug Application (NDA) and other regulatory submissions (INDs, CTX, briefing documents, IB, NDA, BLA, DMF, IMPD, etc.).
• 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 global project teams, Study Execution Teams, and the Executive Committee.
• Provide strategic and tactical guidance and lead the development of regulatory submissions.
• Coordinate and lead agency interactions with Global Health Authorities to achieve company objectives.
• Identify gaps and develop risk mitigation strategies for regulatory submissions; ensure regulatory activities comply with Health Authority requirements.
• Develop global regulatory strategies for the portfolio and stay abreast of regulatory landscape and requirements for drugs, biologics, and devices.
• Lead the regulatory department policies, SOPs, and work instructions; mentor regulatory colleagues; support SVP Regulatory Affairs as required.

Qualifications

• Experience: At least 12 years in Regulatory Affairs in Pharma/Biotech; minimum 3 years direct leadership experience.
• Education: Bachelor‚Äôs degree in a scientific discipline; advanced degree (Master, PharmD, or PhD) preferred.
• Regulatory experience: Strong background in US FDA, EU, and international guidance; experience with major submissions (NDA/NDS/MAA) required; oncology regulatory strategy experience strongly preferred.
• Skills: Excellent oral, written, and presentation skills; strong cross-functional collaboration; ability to manage multiple projects with tight timelines; strong analytical ability in efficacy and safety data.
• Other: On-site presence at headquarters required (minimum 2 days a week); travel up to 20% domestic/international.

Skills

• Regulatory strategy development
• Cross-functional leadership
• Agency negotiation and communication
• Regulatory submissions (INDs, NDA/BLA, DMF, IMPD)
• Veeva or regulatory software tooling familiarity
• Regulatory operations and lifecycle management

Education

• Bachelor‚Äôs degree in a scientific discipline
• Masters, PharmD, or PhD preferred

Additional Requirements

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