Director, Regulatory CMC

Job overview

The Director, Regulatory CMC role is described as fully remote; the listing identifies San Diego, CA. The stated salary range is $235,000–$270,000 per year. Immuneering is a clinical-stage biopharmaceutical company developing oncology therapies and clinical programs. The director develops and executes regulatory strategies for chemistry, manufacturing, and controls activities across the clinical product portfolio. The role supports product development, submissions, and lifecycle management by coordinating regulatory guidance and compliance across internal teams, agencies, and external partners.

What you'll do

• Develop and lead global CMC regulatory strategies for investigational and commercial products
• prepare, review, and submit CMC sections of regulatory documents to the FDA and other authorities, including the EMA
• advise project teams on manufacturing changes, process development, and technology transfers
• monitor regulatory requirements and trends
• represent Regulatory CMC in cross-functional teams
• lead agency interactions on CMC topics
• collaborate with Quality, CMC, R&D, Finance, Legal, Clinical, CROs, and consultants.

What we're looking for

Skills & competencies

director, regulatory cmc

remote

san diego ca

immuneering corporation

full-time

biopharmaceutical

oncology

cmc regulatory affairs

fda submissions

ema

clinical development

$235k–$270k/year

equity

Work arrangement

• Weekend coverage required

Benefits & perks

• Equity participation and benefits
• the posting does not detail specific benefit plans.

Why this role

The posting describes a fully remote work environment and identifies the role as Director/Senior Director in the responsibilities section.

About the employer

IMMUNEERING CORPORATION is hiring for this role. Industry: Research and Development in Biotechnology (except Nanobiotechnology). Sector: 54.