Executive Director, Regulatory CMC

What You'll Do

The Executive Director, Regulatory CMC provides strategic and operational leadership for global CMC regulatory activities across development and (as applicable) commercial products. This role partners closely with CMC, Quality, Technical Operations, Clinical, and Regulatory Affairs leadership to define regulatory CMC strategy, ensure high-quality submissions, and enable product development, licensure, and lifecycle management.

Responsibilities

CMC Regulatory Strategy & Leadership

• Define and execute global CMC regulatory strategies for investigational and marketing applications (e.g., IND/CTA/IMPD/MAA/NDA) and lifecycle changes
• Serve as the primary CMC regulatory lead for one or more programs and/or as functional head for Regulatory CMC
• Provide leadership, coaching, and development for Regulatory CMC staff and contractors; build scalable processes as the portfolio grows

Submissions & Health Authority Interactions

• Lead preparation, review, and approval of CMC sections for regulatory submissions (Module 3, quality overall summaries, responses to information requests)
• Develop and manage CMC-related briefing packages, meeting requests, and responses for global health authority interactions (FDA, EMA, MHRA, PMDA, etc.)
• Ensure consistent interpretation of global CMC regulations and guidance; anticipate regulatory trends and risks

Where You'll Work

This is a U.S.-based remote role that will require quarterly, or as needed visits to our San Francisco Office.

Who You Are

• Advanced degree in a relevant scientific discipline (PhD strongly preferred; MS/BS with significant experience considered)
• Typically 12–15+ years of relevant experience in CMC regulatory affairs within biotech/pharma (biologics, small molecules, cell/gene therapy, or combination products—tailor as needed)
• Demonstrated success leading CMC strategy and authoring/reviewing Module 3 for major global submissions (IND/CTA and at least one marketing application strongly preferred)
• Deep knowledge of global CMC regulations and guidances (ICH Q-series, regional requirements, post-approval change frameworks)
• Proven ability to lead cross-functional teams and influence senior stakeholders in a matrix environment
• Excellent writing, communication, and executive presentation skills
• You have demonstrated curiosity and adaptability in adopting AI-powered tools and technologies

Rewarding Those Who Make the Mission Possible

We have high expectations for our team members. We make sure those working hard for patients are rewarded and cared for in return. 

Financial Benefits:

• Market leading compensation 
• 401K with 100% employer match on first 3% & 50% on the next 2%
• Employee stock purchase program
• Pre-tax commuter benefits
• Referral program with $2,500 award for hired referrals

Health & Wellbeing:

• Comprehensive health care with 100% premiums covered - no cost to you and dependents
• Mental health support via Spring Health (6 therapy sessions & 6 coaching sessions)
• Hybrid work model - employees have the autonomy in where and how they do their work 
• Unlimited flexible paid time off - take the time that you need
• Paid parental leave - 4 months for birthing parents & 2 months for non-birthing parents
• Flex spending accounts & company-provided group term life & disability 
• Subsidized lunch via Forkable on days worked from our office

Skill Development & Career Paths:

• People are part of our growth and success story - from discovery to active drug trials and FDA pipelines, there are endless opportunities for skill development and internal mobility
• We provide career pathing through regular feedback, continuous education and professional development programs via LinkedIn Learning, LifeLabs, Spring Health & BetterUp Coaching
• We celebrate strong performance with financial rewards, peer-to-peer recognition, and growth opportunities\

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