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Senior Director, EU Regulatory Affairs at Olema Oncology - ApplyBlast

Senior Director, EU Regulatory Affairs

Olema Oncology

3 months ago

3.8 on Glassdoor

Dublin, County Dublin, Ireland

Onsite

Full Time

Director

0 applicants

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About this role

The Senior Director, EU Regulatory Affairs leads Olema International's regulatory function in Europe, serving as the EU Authorized Representative and providing strategic leadership for regulatory activities across oncology programs and commercialization. Reporting to the Senior Vice President, Regulatory Affairs, the role develops and executes EU regulatory strategies, manages interactions with the EMA and national authorities, and oversees clinical trial applications, marketing authorization submissions, and lifecycle compliance throughout the European Union.

Responsibilities

Serve as EU Authorized Representative ensuring regulatory compliance
Develop and execute EU regulatory strategies for oncology programs
Lead European regulatory submissions and lifecycle management of MAAs

Skills

Qualifications

Advanced degree in Life SciencesAdvanced degree in PharmacyAdvanced degree in Regulatory Science

About Olema Oncology

olema.com

Headquarters

San Francisco, California, United States

Company Size

51-200 employees

Founded

2007

View Profile

Olema Oncology is a clinical-stage biopharmaceutical company focused on discovering, developing, and commercializing novel targeted therapies for metastatic breast cancer and beyond. The company leverages its deep understanding of endocrine-driven cancers, nuclear receptors, and mechanisms of acquired resistance to advance its pipeline, including Phase 3 breast cancer trials and a KAT6 inhibitor program being evaluated in solid tumors and prostate cancer. Founded in 2006 and headquartered in San Francisco, California, Olema trades on Nasdaq under the ticker OLMA.