CMC Regulatory Lead: Cell Therapy & Novel Therapeutics

Retro; Redwood City (CA); On-site; USD 180,000 - 280,000; Full time

Job summary

Retro is seeking an experienced Regulatory CMC leader for an onsite role in Redwood City. You will own global CMC strategy, lead IND/CTA readiness, and guide cross-functional teams to deliver high-quality regulatory submissions.

You will partner with Analytical Development, Process Development, and Quality, while serving as the primary regulator liaison. A strong background in cell therapies and iPSC-derived products is essential.

Qualifications

• Bachelor’s degree in life sciences; advanced degree preferred.
• 7+ years hands-on regulatory CMC experience.
• Experience leading CMC strategy for cell therapies.
• Experience in IND/CTA enabling early phase development.
• Proven cross-functional leadership across multiple teams.
• Strong ability to translate technical details into regulatory narratives.
• Experience with iPSC-derived cell therapies.
• Global regulatory experience across markets.

Responsibilities

• Own regulatory CMC activities for Retro’s pipeline.
• Develop and lead global CMC regulatory strategies per program.
• Lead preparation of CMC dossiers for INDs/CTAs and amendments.
• Serve as regulatory liaison with health authorities.
• Lead health-authority meetings for CMC topics.
• Respond to health-authority queries and information requests.
• Identify regulatory CMC risks and mitigation strategies.
• Partner with Analytical Development, Process Development, Scientific Operations, and Quality.
• Provide regulatory CMC guidance to external CDMOs and vendors.
• Help establish scalable CMC processes in a growing biotech.

Skills

CMC regulatory strategy

Regulatory leadership

Cross-functional leadership

Regulatory writing

Health authority liaison

Cell therapy experience

Global regulatory experience

Regulatory project management

Education

Bachelor’s degree in life sciences

Advanced degree preferred

Job description

Retro is seeking an experienced Regulatory CMC leader for an onsite role in Redwood City. You will own global CMC strategy, lead IND/CTA readiness, and guide cross-functional teams to deliver high-quality regulatory submissions.

You will partner with Analytical Development, Process Development, and Quality, while serving as the primary regulator liaison. A strong background in cell therapies and iPSC-derived products is essential.