Director, Global Regulatory Affairs - Strategy Lead

Olema Oncology•Boston, MA

3d•Hybrid

About The Position

Olema Oncology is seeking a Director, Global Regulatory Affairs - Strategy Lead to develop and execute innovative regulatory strategies for its products. Reporting to the Senior Director of Regulatory Affairs, this role provides regulatory leadership for the lead asset’s clinical studies and global registrational strategies, and serves as the Regulatory Affairs subject matter expert on cross-functional teams. The Director will provide strategic and tactical guidance on regulatory submissions, represent Olema in interactions with global health authorities, and guide regulatory activities across clinical development and lifecycle management. The position also leads the development of Regulatory Affairs policies, SOPs, and work instructions; supports regulatory dossier software implementation; keeps leadership informed about regulatory developments; leads global regulatory teams; and mentors colleagues. The role is based at Olema’s Boston, Massachusetts, or San Francisco, California office, requires on-site presence at least two days per week, and involves up to 20% domestic and international travel.

Requirements

Bachelor’s degree in a scientific discipline.
At least 12 years of experience in Regulatory Affairs in the pharmaceutical or biotechnology industry.
At least 3 years of direct leadership experience.
Strong negotiation skills with health authorities, including the FDA, EMA, and Health Canada.
Experience with regulatory submissions from IND/CTx through NDA/BLA or marketing applications.
Ability to work in a fast-paced environment in a hands-on fashion.
Excellent oral, written, and presentation skills, including experience presenting to leadership teams.
Demonstrated organizational awareness and experience representing Regulatory Affairs cross-functionally and on global teams.
Strong planning and organizational skills, including the ability to work on multiple projects with tight timelines.
Self-starter who is flexible, proactive, able to manage multiple projects, and able to adapt to changing business needs and priorities.
Team-player approach.
On-site presence at least two days per week.

Nice To Haves

Advanced degree in a scientific discipline; a master’s degree, PharmD, or PhD is preferred.
Oncology therapeutic-area experience is strongly preferred.
Experience developing and executing regulatory strategies in oncology is strongly preferred.
Experience in all phases of development is highly preferred.
Strong understanding of regulatory operational activities.

Responsibilities

Provide regulatory leadership to the lead asset’s clinical studies and lead the development of global registrational strategies.
Develop global regulatory strategies for Olema’s product portfolio in clinical development and lifecycle management.
Represent Regulatory Affairs as a subject matter expert on cross-functional teams and provide regulatory guidance and oversight to global project teams, Study Execution Teams, and the Executive Committee.
Stay informed about regulatory landscapes and requirements affecting drugs, biologics, and devices.
Lead development of regulatory submissions, including INDs, CTx, briefing documents, IBs, NDAs, BLAs, DMFs, and IMPDs.
Represent Olema with global health authorities and lead agency interactions to achieve company objectives.
Identify gaps and develop risk-mitigation strategies for regulatory submissions.
Ensure regulatory activities comply with health authority regulatory requirements.
Coordinate and maintain health authority reporting schedules with cross-functional teams.
Lead development of Regulatory Affairs department policies, SOPs, and work instructions.
Provide regulatory guidance and leadership to cross-functional teams on regulatory dossier software implementation, such as Veeva.
Keep leadership and the organization informed about the regulatory landscape, health authority initiatives, and their impact on Olema’s programs.
Lead global regulatory teams and ensure execution of regulatory strategies to achieve company objectives.
Mentor and develop Regulatory Affairs colleagues.
Support senior Regulatory Affairs leadership as required.
Adapt to and accommodate additional duties as assigned.