Senior Regulatory CMC Strategist

7 days ago


Solana Beach, California, United States LENZ Therapeutics Full time

Overview:

LENZ Therapeutics, a pioneering ophthalmic pharmaceutical company based in San Diego, is seeking a highly skilled Senior Regulatory CMC Strategist to join our team. As a key member of our regulatory affairs department, you will play a vital role in shaping the company's CMC regulatory strategy.

The successful candidate will have extensive experience in drug/device combination products and a deep understanding of global CMC regulations. They will be responsible for creating CMC regulatory strategies for original submissions and changes to approved processes, interpreting global CMC regulations and guidance, and providing input for cross-functional product teams.

Key Responsibilities:

  • Create CMC regulatory strategies for original submissions and changes to approved processes.
  • Interpret global CMC regulations and guidance to identify risks and provide input for cross-functional product teams.
  • Partner with cross-functional stakeholders to deliver input on regulatory submissions (e.g., CMC component(s) of IND/NDA/Master Files, amendments, supplements, annual reports, and health authority interaction briefing documents).
  • Manage regulatory dossiers throughout the product development lifecycle.
  • Lead complex programs.
  • Write and review submission documents to ensure correspondence is of the highest quality in terms of content, organization, clarity, and accuracy.
  • Represent CMC regulatory affairs on product teams and in health authority interactions.
  • Provide regulatory assessments for manufacturing changes and quality compliance and participate in technical risk assessment exercises.
  • Support the development and maintenance of regulatory templates, best practices, and procedures.

Requirements:

  • Prior experience in drug/device combination products strongly preferred.
  • In-depth knowledge of global CMC regulations and understanding of evolving challenges and health authority expectations.
  • Experience in IND and NDA filings.
  • MA/MS degree in life sciences required, advanced degree preferred (PhD, PharmD).
  • Experience of 10+ years with BS/BA; 8+ years with MS/MA or MBA; 6+ years with PhD.

Estimated Salary Range: $140,000 - $160,000 per year, depending on experience.

About LENZ Therapeutics:

LENZ Therapeutics is a late-stage clinical company developing innovative ophthalmic pharmaceutical products that improve vision. Our employees are united in a mission to improve and sustain vision. We foster a diverse and inclusive culture where our employees are encouraged to learn, grow, and innovate, while making a meaningful difference for millions of people around the world.



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