Director, Global Regulatory Affairs - Strategy Lead

Olema Oncology•Boston, MA

4d•$230,000 - $250,000•Hybrid

About The Position

Olema Oncology is a clinical-stage biopharmaceutical company focused on transforming the standard of care for patients with breast cancer and beyond. As the company transforms into a fully integrated oncology company, this role is crucial. The lead product candidate, palazestrant, is in Phase 3 trials for metastatic breast cancer, with potential approval and launch expected in 2028. A follow-on candidate, OP-3136, is also in development for metastatic breast cancer and prostate cancer. The company culture emphasizes a shared purpose, excellence, courage, drive, adaptability, and a nimble, self-starter approach. This role offers the opportunity to be part of a tenacious, courageous, agile, and growing team making a profound impact. As the Director, Global Regulatory Strategy Lead - Regulatory Affairs, reporting to the Senior Director of Regulatory Affairs, you will be responsible for leading the development and execution of innovative regulatory strategies for Olema products. You will serve as the subject matter expert representing Regulatory Affairs on cross-functional teams, providing guidance and oversight to global project teams, Study Execution Teams, and the Executive Committee. This role involves leading the development of regulatory submissions such as INDs, CTx, briefing documents, IB, NDA, BLA, DMF, and IMPD. The position is based in Boston, MA or San Francisco, CA, with up to 20% domestic and international travel required.

Requirements

Bachelor’s degree in a scientific discipline
At least 12 years’ experience in Regulatory Affairs in Pharma/Biotech
Minimum of 3 years direct leadership experience
Strong negotiation skills with health authorities (viz., FDA, EMA, Health Canada, etc.) as well as submissions (IND/CTx to NDA/BLA or Marketing Applications)
Ability to work in a fast-paced environment in a hands-on fashion
Excellent oral, written, and presentation skills, with experience presenting to the leadership teams
Demonstrated proficiency in organizational awareness, including experience working cross-functionally representing the Regulatory Affairs function and on global teams
Excellent planning and organizational skills and ability to work simultaneously on multiple projects with tight timelines
Strong understanding of regulatory operational activities

Nice To Haves

Advanced degree in scientific discipline Masters, Pharm D or PhD is preferred
Experience in Oncology Therapeutic area is strongly preferred
Experience with development and execution of regulatory strategies in Oncology TA is strongly preferred
Experience in all phases of development is highly preferred

Responsibilities

Provide regulatory leadership to the lead asset’s clinical studies and lead the development of global registrational strategies.
Develop innovative global regulatory strategies for the Olema portfolio of products, in clinical development and life-cycle management, as needed, with minimal supervision.
Represent Regulatory Affairs on cross-functional teams as the SME and provide regulatory guidance and oversight to the global project teams, Study Execution Teams, and the Executive committee.
Stay abreast of the regulatory landscape and regulatory requirements impacting drugs, biologics and devices.
Provide strategic and tactical guidance and with minimal supervision lead the development of regulatory submissions (INDs, CTX, briefing documents, IB, NDA, BLA, DMF, IMPD etc.).
Represent Olema with Global Health Authorities and lead Agency interactions to achieve company objectives.
Identify gaps and develop risk mitigation strategies for the regulatory submissions.
Ensure Olema’s regulatory activities are robust and are in compliance with Health Authority (HA) regulatory requirements.
Coordinate and maintain all HA reporting schedules in collaboration of cross-functional teams.
Be flexible to adapt and accommodate additional duties as assigned.
Lead the development of Regulatory Affairs department policies, SOPs, and work instructions.
Provide Regulatory guidance and leadership to cross-functional teams on software implementation for Regulatory dossiers (e.g., Veeva).
Keep the Leadership and the organization fully informed of the regulatory landscape, including HA initiatives and impact on Olema’s programs.
Lead the global regulatory team(s) and ensure execution of the Regulatory strategies to achieve the company objectives.
Mentor and develop other regulatory colleagues in the department.
Support the senior leadership of Regulatory Affairs, as required.