The incumbent will be responsible for providing CMC regulatory expertise through all stages of products lifecycle. This role will support CMC Regulatory Affairs interacting with the FDA and will represent CMC Regulatory on CMC and Regulatory Submission Teams, create timelines and drive the submission plan for Quality Modules.
KEY ROLE AND RESPONSIBILITIES:
- Provide phase-appropriate guidance related to CMC regulatory requirements and expectations for cell therapy development
- Ensure timely escalation of critical issues to senior management by leading CMC regulatory risk assessment, identifying key CMC regulatory issues and mitigation activities needed throughout product life cycle
- Collaborate with CMC colleagues to develop CMC content for original INDs, IND amendments, investigational medicinal product dossiers (IMPD) for inclusion in Clinical Trial Applications (CTA) and BLA/MAA
- Participate in multidisciplinary efforts to prepare CMC updates for regulatory documents including Investigator Brochures, Annual Reports and premeeting meeting packages for Regulatory Authority meetings
- Coordinate, manage CMC regulatory projects including management of submission timelines, ensuring that CMC-related changes are reported in a timely manner to health authorities in accordance with regulatory requirements
- Maintain knowledge of the regulatory environment, regulations, and procedures. Identify CMC regulatory opportunity and risks across development lifecycle
- Partner with key stakeholders in developing tools, templates, and company-wide best practices for CMC regulatory of cell & gene therapies
PREFERRED EDUCATION:
- MSc or PhD within a scientific or related discipline
PREFERRED EXPERIENCE:
- A minimum of 8 years of experience in CMC regulatory affairs
- Experienced in leading CMC regulatory documentation and CMC lifecycle management from IND to marketing applications within the pharmaceutical or biotechnology industry
- Experience with cell therapy is desirable
- Global regulatory experience is preferred but not required
- Minimum 2 years management experience is preferred
KNOWLEDGE, SKILLS AND ABILITIES:
- Knowledge of FDA, EMA and ICH CMC regulations and guidelines for cell therapies
- Proven track record in preparing, reviewing and executing CMC regulatory documents to support clinical studies and marketing applications
- Strong oral and written communication skills
- Demonstrated ability to develop/maintain strong working relationships with the CMC team and cross-functional teams
- Ability to multi-task as needed in a fast-paced start-up environment
- Detail-oriented while also retaining the ability to see the big picture.
- Familiarity with AI-assisted tools for regulatory writing and document drafting (e.g., large language models), with sound judgment on appropriate use, human oversight, and QC of AI-generated content in submission-ready materials.
The salary range for this position is $190,000 to $230,000, annually, with the opportunity to earn an annual bonus. The salary range is an estimate, and the actual salary may vary based on Lyell's compensation practices and an applicant's qualifications and experience. Employees are also eligible to participate in Lyell's Equity Incentive Plan.
We've learned from experience that some of the best people don't always match our requirements perfectly - if you're interested and think you could fit, please don't hesitate to apply.
