Global Regulatory Strategy Director – Oncology

Olema Pharmaceuticals Inc.

Boston (MA)

On-site

USD 230,000 - 250,000

Full time

7 days ago

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Job summary

Olema Oncology is seeking a Director, Global Regulatory Strategy Lead to drive innovative regulatory strategies for Olema products in clinical development and lifecycle management. You will lead regulatory submissions, interact with health authorities, and guide cross-functional teams to ensure on-time, compliant global filings.

The role requires 12+ years in Regulatory Affairs with at least 3 years in leadership, preferably with oncology exposure.

Qualifications

At least 12 years in Regulatory Affairs within Pharma/Biotech.
Minimum 3 years of direct leadership experience.
Experience in Oncology therapeutic area strongly preferred.
Strong negotiation skills with health authorities (FDA/EMA).
Experience with development and execution of regulatory strategies in Oncology.

Responsibilities

Provide regulatory leadership to the lead asset’s clinical studies and develop global registrational strategies.
Develop innovative regulatory strategies for Olema portfolio in clinical development and lifecycle management.
Represent Regulatory Affairs on cross-functional teams as SME and provide guidance to global project teams.
Lead the preparation and submission of regulatory documents (INDs, CTX, NDA/BLA/DMF/IMPD, etc.).
Interact with Global Health Authorities and coordinate agency interactions to meet company objectives.
Identify gaps and develop risk mitigation strategies for regulatory submissions.
Ensure regulatory activities comply with HA requirements and reporting schedules.