The role:The Director/Executive Director, Regulatory CMC will lead regulatory CMC strategy and execution for our cell and gene therapy pipeline and will report directly to the Vice President, Head of Regulatory Affairs. This role is both strategic and hands-on, and will be responsible for the full breadth of CMC regulatory activities across global development programs, from early through late-stage development.
This individual will serve as the primary regulatory CMC point of contact for health authority interactions, author and oversee CMC content for regulatory submissions, and provide regulatory guidance on manufacturing, process, and analytical strategy. This role will work cross-functionally with Process Development, Manufacturing, Analytical Development, Quality, Supply Chain, Clinical Development, and external partners such as CDMOs and testing laboratories.
Key responsibilities:- Lead the development and execution of global regulatory CMC strategies Dispatch programs, from early development through licensure
- Author, review, and approve CMC sections of regulatory submissions, including INDs, CTAs, BLAs/MAAs, amendments, annual reports, and responses to health authority questions
- Serve as the primary regulatory CMC liaison to health authorities (e.g., FDA, EMA, TGA), leading preparation for and participation in CMC-focused meetings and other health authority interactions
- Partner closely with Process Development, Manufacturing, Analytical Development, and Quality to ensure regulatory compliance and submission readiness across the product lifecycle
- Provide strategic regulatory guidance on manufacturing changes, process validation, comparability protocols, and facility qualification/licensure activities
- Assess regulatory risk associated with CMC and manufacturing decisions, and advise senior leadership on mitigation strategies and health authority engagement
- Track, interpret, and communicate evolving global CMC regulatory guidance and policy trends relevant to cell and gene therapy manufacturing
- Manage regulatory CMC aspects of relationships with CDMOs, contract testing laboratories, and other external manufacturing partners
- Build, mentor, and develop regulatory CMC talent as the team and pipeline grow
- Contribute to and help scale regulatory CMC processes, tools, and templates appropriate for a growing organization
- Represent Regulatory CMC on cross-functional program teams and provide regular updates to senior leadership
Required experience & skills:- Bachelor's degree in life sciences, chemistry, engineering, or a related discipline
- Minimum of 10 years of regulatory CMC experience within the biotechnology or pharmaceutical industry
- Direct, hands-on experience authoring and managing CMC sections of IND, BLA, or MAA submissions
- Direct experience with cell therapy, viral vector, or other advanced therapy medicinal product (ATMP) manufacturing
- Deep working knowledge of FDA and ICH CMC regulations and guidelines applicable to biologics; cell and/or gene therapy experience
- Demonstrated experience leading CMC-focused health authority interactions and correspondence
- Track record managing complex manufacturing regulatory strategy, including comparability assessments and post-approval/process changes
- Strong leadership skills with the ability to influence and align cross-functional stakeholders without direct authority
- Excellent written and verbal communication skills, with strong attention to detail
- Ability to operate effectively and independently in a fast-moving, resource-constrained startup environment
Preferred experience & skills:- Advanced degree (MS, PhD, PharmD)
- Experience with global CMC regulatory submissions (e.g., EMA or other ex-U.S. agencies)
- Prior experience supporting solid tumor drug development
- People management experience, with a track record of developing regulatory talent
Our values: Our values guide everything we do. While capabilities and skills are vital, understanding how a potential new colleague would embody our values is central to our hiring decisions.
Determined to deliver: By working with focus and passion, we can provide patients with the solutions they need.
Own every outcome: We can reach new heights when we stay centered on our shared success.
Collaboration at the core: When we band together, our work is better.
Feedback is fundamental: Constructive and authentic positive feedback may be difficult to master but it is vital to our success.
Working here:- We offer a highly competitive compensation package with meaningful ownership through equity
- Excellent coverage for medical, vision, and dental
- 401(k) with generous contribution
- Life insurance
- Flexible PTO policy
- Additional substantial benefits
