Associate Director, Global Regulatory Strategy - International
About The Position
As Associate Director, Global Regulatory Strategy / International Regulatory Affairs, 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 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%
Requirements
- Bachelor’s degree in a scientific discipline required; advanced degree (MS, PharmD, PhD) preferred
- Minimum 10 years of related experience with a Bachelor’s degree; or 7 years and a Master’s degree; or a PhD with 5 years experience; 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)
- 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 independently and within teams
Nice To Haves
- Oncology therapeutic area experience preferred
- Experience collaborating in cross-functional, matrixed teams
- Experience working with CROs and other partners
Responsibilities
- 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
Benefits
- We offer a competitive compensation and benefits package, seeking to provide an open, flexible, and friendly work environment to empower employees and provide them with a platform to develop their long-term careers.
- A Summary of Benefits is available for all applicants.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
11-50 employees
