Senior Manager, Global Regulatory Affairs Strategy

Role Summary

Senior Manager, Global Regulatory Affairs Strategy, reporting to the Senior Director, Global Regulatory Affairs Strategy, provides regulatory strategy support in partnership with cross-functional teams and subject matter experts and manages regulatory aspects through all phases of development. Represents Regulatory Affairs on cross-functional teams, leads the planning and preparation of clinical trial submissions (INDs, CTAs, amendments, briefing documents, Investigator Brochures) and supports global health authority interactions. This role is based in Boston, MA or San Francisco, CA and requires domestic and international travel.

Responsibilities

• With limited supervision, support the development and execution of global regulatory strategies for products in Olema’s pipeline, focusing 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

Qualifications

• Knowledge: Bachelor’s degree in a scientific discipline required; advanced degree (MS, PharmD, PhD) preferred
• Experience: Minimum 5 years of regulatory affairs experience in the pharmaceutical or biotechnology industry
• Experience: Direct experience preparing and submitting clinical trial applications (INDs, CTAs) and managing regulatory authority correspondence
• Experience: Knowledge of global regulatory requirements for clinical development (FDA, EMA, ICH guidelines)
• Experience: Oncology therapeutic area experience preferred
• Experience: Experience collaborating in cross-functional, matrixed teams
• Experience: Experience working with CROs and other partners
• Attributes: Strong organizational, project management, and problem-solving skills
• Attributes: Excellent oral, written, and presentation skills
• Attributes: Flexible and proactive, with the ability to manage multiple projects and adapt to changing priorities
• Attributes: Self-starter with the ability to work both independently and within teams

Education

• Bachelor’s degree in a scientific discipline required; advanced degree (MS, PharmD, PhD) preferred

Skills

• Regulatory strategy development and execution
• Cross-functional collaboration and project leadership
• Regulatory submission planning and management (INDs, CTAs, DSURs, Investigator Brochures)
• Health authority interaction planning and engagement
• Ability to monitor regulatory landscape and apply insights to program strategy
• Vendor management (CROs and regulatory consultants)
• Policy, SOP, and system development (e.g., Veeva)

Additional Requirements

• Domestic and international travel, approximately 10–15%