Senior Director, Global Regulatory Strategy Lead - Regulatory Affairs

Olema Oncology • San Francisco, CA

107d • $275,000 - $290,000

About The Position

As the Senior Director, Global Regulatory Strategy Lead - Regulatory Affairs reporting to the Senior Vice President of Regulatory Affairs, your responsibilities will include the following: Lead the development of the New Drug Application (NDA) and the development and execution of innovative regulatory strategies supporting Olema products. You will 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. Additionally, you will provide strategic and tactical guidance and lead the development of regulatory submissions (INDs, CTx, briefing documents, IB, NDA, BLA, DMF, IMPD etc.). This role is based out of either our Boston, MA or San Francisco, CA office and will require domestic and international travel up to 20%. Your work will primarily encompass leading the development and submission of the NDA for the company's lead program, developing innovative global regulatory strategies for the Olema portfolio of products, and ensuring Olema’s regulatory activities are robust and compliant with Health Authority (HA) regulatory requirements.

Requirements

• 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.
• Strong understanding of US FDA, EU and international pharmaceutical guidance and regulations.
• Experience with major regulatory submissions (e.g. NDA/NDS/MAA).
• Experience in strategic problem-solving and negotiation with Health Authorities.
• Ability to work in a fast-paced environment in a hands-on fashion.
• Excellent oral, written, and presentation skills.
• Demonstrated proficiency in organizational awareness and cross-functional collaboration.
• Excellent planning and organizational skills.
• Experience in all phases of development and post-marketing activities.
• Demonstrated ability to analyze and interpret efficacy and safety data.
• Strong understanding of regulatory operational activities.

Nice To Haves

• Experience in Oncology Therapeutic area is strongly preferred.
• Experience in all phases of development and post-marketing activities is highly preferred.

Responsibilities

• Lead the development and submission of the NDA for the company's lead program.
• Develop innovative global regulatory strategies for the Olema portfolio of products.
• Represent Regulatory Affairs on cross-functional teams as the SME.
• Provide regulatory guidance and oversight to global project teams and the Executive Committee.
• Stay abreast of the regulatory landscape and requirements impacting drugs, biologics, and devices.
• Lead the development of regulatory submissions (INDs, CTx, briefing documents, IB, NDA, BLA, DMF, IMPD etc.).
• Represent Olema with Global Health Authorities and lead Agency interactions.
• Identify gaps and develop risk mitigation strategies for regulatory submissions.
• Coordinate and maintain all HA reporting schedules in collaboration with cross-functional teams.
• Lead the development of Regulatory Affairs department policies, SOPs, and work instructions.
• Provide Regulatory guidance and leadership on software implementation for Regulatory dossiers.
• Keep the Leadership and organization informed of the regulatory landscape.
• Lead the global regulatory team(s) and ensure execution of Regulatory strategies.
• Mentor and develop other regulatory colleagues in the department.
• Support SVP Regulatory Affairs as required.

Benefits

• Competitive compensation and benefits package.
• Equity and bonus opportunities.
• Open, flexible, and friendly work environment.
• Platform for long-term career development.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Master's degree
• Number of Employees: 101-250 employees