Senior Director, Global Regulatory Strategy Lead - Regulatory Affairs

Role Summary

Senior Director, Global Regulatory Strategy Lead – Regulatory Affairs, reporting to the Senior Vice President of Regulatory Affairs. Lead development of regulatory strategies, oversee submissions and agency interactions, and provide regulatory guidance across global project teams. Based in Boston, MA or San Francisco, CA with domestic and international 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 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 process for the company’s lead program.
• Stay abreast of regulatory landscape and requirements impacting drugs, biologics, and devices; coordinate and maintain HA reporting schedules in collaboration with cross-functional teams.
• Represent Olema with Global Health Authorities and lead Agency interactions to achieve company objectives; identify gaps and develop risk mitigation strategies for submissions; ensure regulatory activities are robust and compliant with HA requirements.
• Mentor and develop regulatory colleagues; lead the global regulatory team(s) and ensure execution of regulatory strategies to achieve company objectives.
• Provide Regulatory guidance on software implementations for regulatory dossiers (e.g., Veeva); lead department policies, SOPs, and work instructions.
• Keep leadership informed of regulatory landscape and HA initiatives and impact on Olema’s programs; support SVP Regulatory Affairs as required.
• Be flexible to adapt to additional duties as assigned; on-site presence at headquarters is required (minimum 2 days a week).

Qualifications

• Knowledge: Bachelor’s degree in a scientific discipline; advanced degree (Masters, PharmD, or PhD) preferred.
• Experience: Minimum of 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 strongly preferred; strong understanding of US FDA, EU and international guidelines and drug development processes; experience with major regulatory submissions (NDA/NDS/MAA) is must; experience in strategic problem-solving and negotiation with Health Authorities; ability to work in a fast-paced environment; excellent oral/written/presentation skills; cross-functional collaboration; strong planning and organizational skills; experience across all development stages and post-marketing activities highly preferred.
• Attributes: Self-starter; flexible and proactive; team player; on-site presence at headquarters required (minimum 2 days a week).

Education

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

Skills

• Regulatory strategy development and execution
• Cross-functional leadership and SME governance
• Regulatory submissions management (INDs, NDA, BLA, DMF, IMPD, etc.)
• Agency communications and negotiations with health authorities
• Regulatory landscape monitoring and risk assessment
• Regulatory operations and dossier systems (e.g., Veeva)
• Regulatory project management and multiple project handling
• Clear written and verbal communication; executive-level presentation experience

Additional Requirements

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