Lead, Regulatory Affairs CMC — Cell Therapy & Novel Therapeutics

Job overview

The Lead, Regulatory Affairs CMC — Cell Therapy & Novel Therapeutics is an onsite role in Redwood City, California. The stated salary is $225,000–$260,000 per year, with equity and benefits also included in total compensation. Retro develops therapies focused on cellular reprogramming and autophagy to address diseases driven by aging biology. The role owns regulatory CMC strategy and operations across the pipeline, translating technical development into submissions and health-authority engagement. It builds regulatory capabilities and coordinates internal teams and external partners to advance programs through development and toward regulatory milestones.

What you'll do

• Develop and execute global CMC regulatory strategies and plans
• lead CMC dossier preparation for INDs/CTAs and marketing applications, amendments, and reports
• serve as regulatory liaison for CMC communications and submissions
• lead health-authority meetings and responses to queries
• identify and mitigate regulatory risks
• partner with Analytical Development, Process Development, Scientific Operations, and Quality
• guide external CDMOs and vendors
• establish scalable CMC processes.

What we're looking for

Skills & competencies

regulatory affairs lead

cmc

cell therapy

novel therapeutics

full-time

onsite

redwood city ca

retro

$225k–$260k

ind/cta submissions

health authority strategy

equity

401(k) match

paid parental leave

Work arrangement

• Weekend coverage required

Benefits & perks

• Equity
• medical, dental, and vision insurance
• 401(k) with 4% matching
• unlimited time off
• 10 company holidays
• paid parental leave
• annual learning and development stipend
• monthly longevity stipend
• free lunch and snacks.

Why this role

Requires seven or more years of hands-on regulatory CMC experience and demonstrated cell-therapy strategy leadership. Experience in early-phase development is required; iPSC-derived therapies, multiple modalities, late-phase work, and extensive global experience are bonuses.

About the employer

Retro is hiring for this role. Industry: Biological Product (except Diagnostic) Manufacturing. Sector: 32.