Senior Manager, Global Regulatory Affairs Strategy

Senior Manager, Global Regulatory Affairs Strategy

Olema Oncology is dedicated to developing better medicines for breast cancer and beyond. Our lead program, palazestrant (OP-1250), is a complete estrogen receptor antagonist (CERAN) currently in development for metastatic breast cancer with blockbuster potential as a monotherapy and in combination in ER+/HER2- metastatic breast cancer. Our follow-on product candidate, OP-3136, is a potent KAT6 inhibitor with best-in-class potential.

Our scientific breakthroughs are accelerated through the ways in which we fearlessly support, motivate, and challenge one another. At Olema, we know that when we put people first, our work becomes second to none. If you’re ready to join us at the edge of something unstoppable, let’s make a profound impact together for our patients, for your career, for what’s beyond
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About the Role >>>
Senior Manager, Global Regulatory Affairs Strategy

As the Senior Manager, Global Regulatory Affairs Strategy, reporting to the Senior Director, Global Regulatory Affairs Strategy, you will provide regulatory strategy support in partnership with cross functional teams and subject matter experts and manage regulatory aspects through all phases of development.

You will represent Regulatory Affairs on cross-functional teams, lead the planning and preparation of clinical trial submissions (INDs, CTAs, amendments, briefing documents, Investigator Brochures) and support global health authority interactions.

This role can be based out of our Boston, MA or San Francisco, CA office and will require domestic and international travel, approximately 10–15%

Your Work Will Primarily Encompass:

• With limited supervision, support the development and execution of global regulatory strategies for products in Olema’s pipeline, with a focus on early development and clinical trial applications
• Serve as the Regulatory Affairs representative on global project teams and Study Execution Teams, providing regulatory input and ensuring alignment with program objectives and timelines
• Prepare and coordinate high-quality regulatory global submissions, including INDs, CTAs, amendments, annual reports, DSURs, Investigator Brochures, and briefing documents
• Under the supervision of the Senior Director, Regulatory Affairs, contribute to planning and execution of regulatory interactions with health authorities (e.g., FDA, EMA, Health Canada, MHRA), including meeting requests, briefing packages, and follow-up correspondence
• Monitor the global regulatory landscape to identify requirements, trends, and potential impact on Olema’s development programs
• Coordinate and maintain health authority reporting schedules in collaboration with cross-functional teams
• Partner with external vendors (e.g., CROs, regulatory consultants) to ensure high-quality and timely submissions
• Support development of Regulatory Affairs departmental policies, SOPs, and systems (e.g., Veeva) to enhance submission quality and efficiency
• Assist in risk assessment and mitigation planning for regulatory deliverables

Ideal Candidate Profile

We are looking for a collaborative and driven Regulatory Affairs professional who thrives in a fast-paced environment and brings expertise in regulatory strategy

Knowledge:

Bachelor’s degree in a scientific discipline required; advanced degree (MS, Pharm

D, PhD) preferred

Experience:

• Minimum 5 years of regulatory affairs experience in the pharmaceutical or biotechnology industry
• Direct experience preparing and submitting clinical trial applications (INDs, CTAs) and managing regulatory authority correspondence
• Knowledge of global regulatory requirements for clinical development (FDA, EMA, ICH guidelines)
• Oncology therapeutic area experience preferred
• Experience collaborating in cross-functional, matrixed teams
• Experience working with CROs and other partners

Attributes:

• Strong organizational, project management, and problem-solving skills
• Excellent oral, written, and presentation skills
• Flexible and proactive, with the ability to manage multiple projects and adapt to changing priorities
• Self-starter with the ability to work both…