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Cmc Operations Jobs in California (NOW HIRING)

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Cmc Operations information

What is the difference between Cmc Operations vs CMC Regulatory Affairs?

AspectCmc OperationsCMC Regulatory Affairs
Required CredentialsBachelor's degree in life sciences, engineering, or related field; experience in manufacturing or quality controlDegree in life sciences, pharmacy, or related; regulatory certifications often preferred
Work EnvironmentManufacturing plants, quality control labs, supply chainRegulatory agencies, corporate offices, compliance teams
Industry UsageManufacturing, quality assurance, supply chain managementRegulatory submissions, compliance, documentation
Common Search/ComparisonYesYes

While both Cmc Operations and CMC Regulatory Affairs are essential in the pharmaceutical industry, Cmc Operations focuses on manufacturing, quality control, and supply chain processes. In contrast, CMC Regulatory Affairs handles regulatory submissions, compliance, and documentation to ensure products meet legal standards. Understanding these differences helps professionals and employers align roles with their expertise and industry needs.

What are popular job titles related to Cmc Operations jobs in California? For Cmc Operations jobs in California, the most frequently searched job titles are:
What job categories do people searching Cmc Operations jobs in California look for? The top searched job categories for Cmc Operations jobs in California are:
What cities in California are hiring for Cmc Operations jobs? Cities in California with the most Cmc Operations job openings:
Cmc Operations jobs near you
Infographic showing various Cmc Operations job openings in California as of August 2026, with employment types broken down into 85% Full Time, 12% Part Time, 1% Temporary, and 2% Contract. Highlights an 94% Physical, 2% Hybrid, and 4% Remote job distribution.

Director Regulatory Affairs - CMC

Clinical Dynamix, Inc.

San Diego, CA

$160K - $211K/yr

Full-time

Re-posted 4 days ago

Job description

About the Role:

Responsible for the strategic Regulatory CMC leadership for assigned commercial products to ensure regulatory compliance with the approved marketing applications (MAA/NDA/BLA) and assigned development projects leading to successful preparation and clearance/approval of IND/CTA/MAA/NDA/BLA submissions in a timely and efficient manner.

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Your Contributions (include, but are not limited to):

  • Responsible for the regulatory CMC leadership of one or more commercial and development projects, including responsibility for regulatory strategy, IND/CTA preparation, maintenance and update activities, interaction with and preparation for key milestone meetings with regulatory agencies with focus on the CMC aspects
  • Develops CMC regulatory strategies to ensure optimal product development leading to the earliest possible approvals by relevant regulatory authorities
  • Provides strategic guidance on global regulatory CMC requirements to management and project teams
  • Provides guidance to senior management and departments within CMC areas on all regulatory issues for the strategic development, planning, compilation and submission of assigned IND/CTA/MAA/NDA/BLA
  • May represent the company by leading interactions and negotiations with regulatory agencies during all stages of development and registration
  • Manages preparation of assigned regulatory submissions (IND/CTA/MAA/NDA/BLA)
  • Reviews and approves reports intended for use in regulatory submissions
  • Actively engages with stakeholder groups to help shape science based regulatory decision making
  • Acts as regulatory CMC liaison with partner companies and contract manufacturers
  • Provides expertise in translating regulatory requirements into practical, workable plans
  • Interacts with regulatory agencies for assigned projects
  • Selects, develops and evaluates personnel to ensure the efficient operation of the function
  • Other duties as assigned

Requirements:

  • BS/BA degree AND 12+ years experience in Regulatory Affairs in the Pharmaceutical/Biotech industry. Prior project regulatory leadership experience with specific focus on the CMC aspects for small molecules, biologics, and/or gene therapies. Leadership experience in preparation and preferably, negotiation to marketing approval in major markets is desired. OR
  • Master's degree preferred AND 10+ years similar experience noted above OR
  • PhD preferred AND 7+ years similar experience noted above OR
  • Extensive previous managerial experiences also required
  • Acts as a "trusted advisor" across the company and may be recognized as an external expert
  • Provides strategy, vision and direction regarding issues that may have company-wide impact
  • Requires in-depth knowledge of the functional area, business strategies, and the company’s goals
  • Possesses industry-leading knowledge
  • Ability to apply advanced analytical thought and judgment
  • Strong leadership, coaching, employee development skills
  • Ability to influence others with or without authority at all levels of the organization
  • Proactive, innovative, with excellent problem-solving skills
  • Ability to work in a cross functional team and matrix environment
  • Excellent written, presentation, and verbal communication skills
  • Extensive project regulatory leadership and expertise, specifically focused on the CMC aspects for small molecules, biologics, and/or gene therapies
  • Detailed knowledge of FDA and EMA regulations and guidance for drug development, preparation and management of IND/CTA/MAA/NDA/BLA
  • Demonstrated leadership expertise in preparation and preferably, negotiation to marketing approval in major markets