Regulatory Affairs
South San Francisco, California, United States
09/20/22

Associate Director, CMC Regulatory

At Lyell, our vision is to develop curative cell-based immunotherapies for solid tumor cancers. We have innovative science originating from our founder’s world class labs and a unique and disruptive approach to research and development. Our company is first and foremost focused on understanding the science. We are a learning organization, dependent on deep collaborative relationships between all of our colleagues, partners and founders. Our culture is based on Science, Respect, Collaboration and Courage and it reflects who we are and the environment we are creating.
 

POSITION SUMMARY:

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

PREFERRED EDUCATION:

  • MSc or PhD within a scientific or related discipline

 PREFERRED EXPERIENCE:  

  • 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.

PROBLEM SOLVING:

  • Proactively identifies complex, multi-faceted technical problems
  • Plays a strategic role in recommending and developing appropriate solutions

DECISION-MAKING:

  • 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.

Lyell is proud to be an equal opportunity employer and does not discriminate on the basis of race, color, citizenship status, national origin, ancestry, sex, sexual orientation, age, religion, creed, physical or mental disability, medical condition, marital status, veteran status or any other characteristics protected under applicable federal, state and local laws.
 
The Company complies with all laws respecting equal employment opportunity and does not discriminate against applicants with regard to any protected characteristic as defined by federal, state, and local law.  This position requires you to work onsite at the Company’s facilities and the Company requires that all employees working in its facilities be fully vaccinated (except as required by applicable law).  Therefore, this position requires you to be fully vaccinated from COVID-19, subject to reasonable accommodations for medical or religious reasons, and/or as otherwise required by applicable law.  The Company considers you fully vaccinated once 14 days have passed since you received either the second dose in a two-dose COVID-19 vaccine series or a single-dose COVID-19 vaccine.  The vaccine must have been FDA approved, have emergency use authorization from the FDA, or, for persons fully vaccinated outside of the U.S., be listed for emergency use by the World Health Organization.”
 
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.
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