Senior Director, Global Regulatory Strategy Lead - Regulatory Affairs

Role Summary

Senior Director, Global Regulatory Strategy Lead - Regulatory Affairs overseeing the development and execution of regulatory strategies for Olema's product portfolio, with primary responsibility for NDA development and submissions, and cross-functional regulatory guidance.

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 of regulatory submissions for the company's lead program and coordinate agency interactions to achieve company objectives
• Identify gaps and develop risk mitigation strategies for regulatory submissions
• Ensure regulatory activities are robust and in compliance with Health Authority requirements
• 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 on software implementation for regulatory dossiers (e.g., Veeva)
• Keep leadership informed of regulatory landscape and HA initiatives and impact on Olema‚Äôs programs
• Lead the global regulatory team(s) and ensure execution of 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 (Masters, PharmD, or PhD) preferred
• Experience: At least 12 years 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 guidance, regulations, drug development process, and industry practices
• Experience with major regulatory submissions (NDA/NDS/MAA)
• Proven ability to solve problems and negotiate with Health Authorities and lead 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
• Demonstrated cross-functional collaboration and global team experience
• Strong planning and organizational skills; ability to manage multiple projects with tight timelines
• Experience across all development phases and post-marketing activities preferred
• Ability to analyze and interpret efficacy and safety data
• Strong understanding of regulatory operational activities

Skills

• Strategic regulatory thinking
• Regulatory submissions and dossier development
• Agency negotiation and interactions
• Cross-functional leadership
• Regulatory operations and lifecycle management
• Software tools for regulatory dossiers (e.g., Veeva)

Education

• Bachelor‚Äôs degree in a 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%