Associate Director, Global Regulatory Strategy ...

@ Olema Oncology

About Olema Oncology

Olema Oncology is a cancer medicines company dedicated to impacting breast cancer and beyond. Our lead program, palazestrant (OP-1250), is a differentiated oral medicine known as a complete estrogen receptor antagonist (CERAN) initially in development for metastatic breast cancer. Our pipeline also includes OP-3136, a potent, selective oral inhibitor of the KAT6 pathway. We are building a focused team committed to our mission with intention and clarity. For more information, visit our website.

About the Role: Associate Director, Global Regulatory Strategy - International

Reporting to the Senior Director of Regulatory Affairs Strategy, you will contribute to the development and execution of regulatory strategies for Olema’s products in early to late-stage clinical development. You will be a key Regulatory Affairs representative on cross-functional teams and lead planning and preparation of clinical trial submission documents such as INDs, CTAs, amendments, briefing documents, and Investigator Brochures. You will also support global health authority interactions.

Primary Responsibilities

• Support the development and execution of global regulatory strategies.
• Provide regulatory input on cross-functional project teams.
• Prepare and coordinate high-quality regulatory submissions including INDs, CTAs, amendments, annual reports, DSURs, and Investigator Brochures.
• Assist in planning and executing regulatory interactions with health authorities (FDA, EMA, Health Canada, MHRA).
• Monitor global regulatory landscape changes and coordinate reporting schedules.
• Partner with external vendors such as CROs and regulatory consultants.
• Support development of departmental policies and SOPs.
• Assist in risk assessment and mitigation planning for regulatory deliverables.

Ideal Candidate Profile

The ideal candidate has a Bachelor’s degree in a scientific discipline (advanced degree preferred), 7+ years of regulatory affairs experience in the pharmaceutical or biotechnology industry, and direct experience with clinical trial applications and global regulatory requirements. Experience in the oncology therapeutic area, excellent communication, and strong project management skills are essential.

Additional Information

This role is based in Boston, MA and requires 10–15% domestic and international travel. The compensation package includes a competitive base pay range, equity, bonus, and benefits.

Key skills/competency

Associate Director, Global Regulatory Strategy - International: Regulatory Strategy, Clinical Submissions, Global Health Authorities, IND, CTA, Oncology, Cross-functional Teams, Project Management, CRO Collaboration, Regulatory Documentation.