Director, Global Regulatory Affairs Strategy Lead

Olema Oncology•San Francisco, CA

3d•Onsite

About The Position

Olema Oncology is hiring a Director, Global Regulatory Affairs Strategy Lead within Regulatory Affairs. Reporting to the Senior Director of Regulatory Affairs, this leader will develop and execute innovative regulatory strategies for Olema’s products and provide regulatory expertise, guidance, and oversight to global project teams, Study Execution Teams, and the Executive Committee. The role leads regulatory strategy for the lead asset’s clinical studies and global registrations, supports products in clinical development and lifecycle management, and represents Olema in interactions with global health authorities. It also provides strategic and tactical leadership for regulatory submissions, identifies submission gaps and mitigation strategies, and ensures regulatory activities meet health authority requirements. The position also leads development of Regulatory Affairs policies, SOPs, and work instructions; guides cross-functional teams on regulatory dossier software implementation; keeps leadership informed about regulatory developments and their impact on Olema programs; and leads and develops global regulatory teams and colleagues. The role is based in the Boston, Massachusetts or San Francisco, California office, requires onsite presence at least two days per week, and involves up to 20% domestic and international travel. The expected annual base pay range is $230,000–$250,000. Compensation may vary based on location, market, job-related knowledge, skills, capabilities, and experience. The total compensation package also includes equity, bonus, and benefits.

Requirements

Bachelor’s degree in a scientific discipline.
At least 12 years of experience in Regulatory Affairs in Pharma/Biotech.
At least 3 years of direct leadership experience.
Strong negotiation skills with health authorities, such as the FDA, EMA, and Health Canada, and experience with submissions from IND/CTx through NDA/BLA or marketing applications.
Ability to work hands-on in a fast-paced environment.
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.
Excellent planning and organizational skills, including the ability to manage multiple projects with tight timelines.
Strong understanding of regulatory operational activities.
Self-starter who is flexible, proactive, and able to manage multiple projects and adapt to changing business needs and priorities.
Team-player approach.
Ability to work onsite at least two days a week.
Ability to travel domestically and internationally up to 20%.

Nice To Haves

A master’s degree, PharmD, or PhD in a scientific discipline.
Experience in the oncology therapeutic area.
Experience developing and executing regulatory strategies in oncology.
Experience in all phases of development.

Responsibilities

Lead regulatory strategy for the lead asset’s clinical studies and develop global registrational strategies.
Develop innovative global regulatory strategies for Olema’s portfolio in clinical development and lifecycle management.
Represent Regulatory Affairs as a subject matter expert on cross-functional teams and provide guidance and oversight to global project teams, Study Execution Teams, and the Executive Committee.
Monitor regulatory landscapes and requirements affecting drugs, biologics, and devices.
Lead the 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 requirements.
Coordinate and maintain health authority reporting schedules with cross-functional teams.
Adapt to and undertake additional duties as assigned.
Lead development of Regulatory Affairs department policies, SOPs, and work instructions.
Provide regulatory guidance and leadership to cross-functional teams implementing software for regulatory dossiers, 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 strategies to achieve company objectives.
Mentor and develop Regulatory Affairs colleagues.
Support senior Regulatory Affairs leadership as required.