Director, Regulatory Affairs

Job overview

The Director, Regulatory Affairs role is onsite in San Diego, CA. The stated annual salary range is $209,050–$249,042. BlossomHill Therapeutics is a clinical-stage biopharmaceutical company developing small-molecule medicines for significant unmet needs in cancer treatment. The director leads regulatory strategy and submission activities for clinical development programs, coordinating with global health authorities and cross-functional teams. The role supports compliant development and potential commercialization by preparing submissions, responding to agency questions, and providing regulatory guidance.

What you'll do

• Develop regulatory strategies and plans
• prepare and execute submissions throughout product life cycles
• lead responses to health authority questions
• maintain regulatory strategy documents and files
• interpret regulations and provide guidance
• review SOPs and policies
• coordinate submission documents with subject-matter experts
• represent Regulatory Affairs on project and study teams
• collaborate with research and development functions.

What we're looking for

Skills & competencies

director regulatory affairs

san diego ca

blossomhill therapeutics

biopharmaceuticals

regulatory strategy

clinical development

health authority submissions

fda

ema

oncology

regulatory compliance

cross-functional teams

Work arrangement

• Weekend coverage required

Why this role

Serves as Regulatory Program Lead for one or more clinical programs and supports regulatory work across the company’s development portfolio.

About the employer

BLOSSOMHILL THERAPEUTICS INC is hiring for this role. Industry: All Other Professional, Scientific, and Technical Services. Sector: 54.