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← Lyell Immunopharma

Associate Director, CMC Regulatory

Lyell Immunopharma
Location
Seattle, Washington, United States
Posted
1 month ago
Department
Regulatory Affairs
Salary
$190,000 to $230,000
What they actually want (must-haves)
  • MSc or PhD within a scientific or related discipline
  • A minimum of 8 years of experience in CMC regulatory affairs
  • Proven track record in preparing, reviewing and executing CMC regulatory documents to support clinical studies and marketing applications
  • Strong oral and written communication skills
  • Ability to multi-task in a fast-paced start-up environment
  • Detail-oriented while also retaining the ability to see the big picture.
Nice to have
  • Experience with cell therapy
  • Global regulatory experience
  • Minimum 2 years management experience
  • Familiarity with AI-assisted tools for regulatory writing and document drafting
What the job really is

The Associate Director, CMC Regulatory will provide regulatory expertise throughout the lifecycle of cell therapy products, ensuring compliance with CMC regulatory requirements. Responsibilities include leading risk assessments, managing submission timelines, and collaborating with cross-functional teams to prepare regulatory documents. The role also involves maintaining knowledge of the regulatory environment and developing best practices for CMC regulatory processes.

Benefits
  • Salary range of $190,000 to $230,000 annually
  • Opportunity to earn an annual bonus
  • Eligibility to participate in Lyell’s Equity Incentive Plan
Things to weigh
  • No specific details on the company's current projects or pipeline are provided
  • The role may involve navigating a complex regulatory environment which can be challenging
  • The salary range is stated as an estimate and may vary based on qualifications and experience
Job score3.8/5
Benefits2/5
Freshness4/5
Career value4/5
Role clarity4/5
Pay transparency5/5

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