The Associate Director, CMC Regulatory Affairs, will be responsible for providing CMC regulatory expertise through all stages of products lifecycle. This individual will represent CMC Regulatory Affairs on CMC and Regulatory Submission Teams, create timelines for development, compilation, maintenance, and review of the Quality Module for regulatory submissions.
KEY ROLE AND RESPONSIBILITIES:
- Provide phase-appropriate guidance related to CMC regulatory requirements and expectations for cell therapy development
- Interact with regulatory agencies and represent Regulatory CMC at HA meetings, including preparing subject matter experts (SMEs) in Process Development, Manufacturing, Quality, and Supply Chain
- Ensure timely escalation of critical issues to senior management by leading 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
- MSc or PhD within a scientific or related discipline
- A minimum of 8 years of experience in regulatory affairs with a focus on leading CMC 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
KNOWLEDGE, SKILLS AND ABILITIES:
Knowledge of regulations and health authority guidelines for cell therapies
- Proven track record in preparing, reviewing and executing CMC regulatory documents to support IND filings and IND amendments and marketing applications
- Experienced interacting with regulatory agencies including formal meetings as lead CMC regulatory representative
- Strong oral and written communication skills
- Demonstrated ability to develop/maintain strong working relationships with the CMC team and cross-functional teams, participate on and/or lead multifunctional teams
- Ability to multi-task as needed in a start-up environment, Flexible with demonstrated ability to work in a fast-paced, timeline-driven environment
- Detail-oriented while also retaining the ability to see the big picture.
- Proactively identifies complex, multi-faceted technical problems
- Plays a strategic role in recommending and developing appropriate solutions
- Understand the decision-making framework, have capability of making decisions after considering all factors leading to the decision,
- The decision can impact regulatory or cross functional teams.
At Lyell, we believe that highest performing teams include people from a wide variety of backgrounds and experiences who respectfully challenge each other. We are committed to building an open, diverse and inclusive culture for all employees.