Senior Director, Global Regulatory Strategy Lead - Regulatory Affairs

Role Summary

Senior Director, Global Regulatory Strategy Lead - Regulatory Affairs. Lead development and execution of innovative regulatory strategies supporting Olema products; act as Regulatory Affairs SME on cross-functional teams; oversee regulatory submissions and interactions with Health Authorities. 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 of regulatory submissions and ensure alignment with Health Authority requirements
• 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
• Ensure Olema’s regulatory activities are robust and compliant with Health Authority regulatory 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 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’s programs
• Lead the global regulatory teams 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

• Bachelor’s degree in a scientific discipline
• Advanced degree in scientific discipline (Masters, Pharm D or PhD) preferred
• At least 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 Therapeutic area strongly preferred
• Strong understanding of US FDA, EU and international pharmaceutical guidance and drug development processes
• 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, hands-on environment
• Excellent oral, written, and presentation skills; experience presenting to leadership
• Proficiency in cross-functional collaboration on global teams
• Strong planning and organizational skills; ability to manage multiple projects with tight timelines
• Experience in all phases of development and post-marketing activities highly preferred
• Ability to analyze and interpret efficacy and safety data; strong understanding of regulatory operational activities
• Self-starter; flexible and proactive; team player
• On-site presence at headquarters required (minimum 2 days a week)

Skills

• Regulatory strategy development
• Regulatory submissions and dossier development
• Health Authority interactions and negotiations
• Cross-functional leadership and mentorship
• Regulatory operations and lifecycle management
• Strategic thinking and problem-solving
• Communication and presentation to leadership

Education

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

Additional Requirements

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