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Cmc Jobs in California (NOW HIRING)

Calico

Director, Regulatory CMC

South San Francisco, CA · On-site

$275K - $280K/yr

The Director of Regulatory CMC will lead the development and execution of global CMC regulatory strategies for our pipeline of small molecules and monoclonal antibodies to accelerate clinical ...

Vaxcyte

Associate Director, Regulatory CMC

San Carlos, CA · On-site +1

$180K - $210K/yr

Provides regulatory CMC guidance to various cross-functional teams and ensures all applicable global regulatory requirements are considered and incorporated into product development. Conducts routine ...

AbbVie

Director, RA CMC

Irvine, CA

$161K - $212K/yr

Prepares CMC regulatory strategies that enable first pass approvals. Develops and manages content strategy for regulatory submissions, including INDs/CTAs and amendments, new marketing applications ...

Gilead

Manager, Regulatory Affairs CMC

Foster City, CA

$146K - $189K/yr

The CMC Regulatory Affairs Manager is responsible forsupporting the planning, coordination, and execution of CMC regulatory activities across global clinical and commercial programs. This role ...

AbbVie

Director, RA CMC

Irvine, CA · On-site

$160K/yr

Prepares CMC regulatory strategies that enable first pass approvals. Develops and manages content strategy for regulatory submissions, including INDs/CTAs and amendments, new marketing applications ...

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How much do cmc jobs pay per hour?

As of Jul 29, 2026, the average hourly pay for cmc in California is $30.83, according to ZipRecruiter salary data. Most workers in this role earn between $18.99 and $36.06 per hour, depending on experience, location, and employer.

What are the key skills and qualifications needed to thrive as a CMC (Chemistry, Manufacturing, and Controls) professional, and why are they important?

To thrive as a CMC professional, you need expertise in pharmaceutical sciences, regulatory requirements, and process development, typically supported by a degree in chemistry, pharmacy, or a related field. Familiarity with regulatory submission systems, analytical tools, and quality management software is essential. Strong project management, attention to detail, and effective communication are vital soft skills for coordinating cross-functional teams and ensuring compliance. These skills and qualities are critical to guarantee the safety, efficacy, and regulatory approval of pharmaceutical products.

What are some common challenges faced by a CMC professional when coordinating between R&D, manufacturing, and regulatory teams?

CMC professionals often encounter challenges in aligning the timelines and priorities of R&D, manufacturing, and regulatory teams. Ensuring that product development meets both regulatory requirements and manufacturing feasibility can require extensive cross-functional communication and problem-solving. Additionally, adapting to evolving regulatory guidelines and integrating feedback from multiple stakeholders demands strong project management skills. Overcoming these challenges is essential for maintaining project momentum and ensuring successful product submissions.

What are CMC professionals?

CMC stands for Chemistry, Manufacturing, and Controls. CMC professionals are responsible for ensuring that pharmaceutical products are developed, manufactured, and controlled in compliance with regulatory standards. Their work includes overseeing formulation development, analytical testing, process validation, and documentation required for regulatory submissions. CMC experts play a critical role in bringing safe and effective drugs to market by ensuring product quality and consistency throughout the development and manufacturing process.

What is the difference between CMC vs Regulatory Affairs Specialist?

AspectCMCRegulatory Affairs Specialist
Required CredentialsBachelor's degree in life sciences, chemistry, or pharmacy; often additional certifications in pharmaceutical sciencesBachelor's degree in life sciences, pharmacy, or related field; certifications in regulatory affairs are common
Work EnvironmentLaboratories, manufacturing sites, and R&D departments within pharmaceutical companiesRegulatory agencies, pharmaceutical companies, and consulting firms
Industry UsageFocuses on drug development, manufacturing, and quality documentationFocuses on compliance, submissions, and communication with regulatory bodies

While both CMC and Regulatory Affairs Specialists work within the pharmaceutical industry, CMC professionals primarily handle the chemistry, manufacturing, and control aspects of drug development. Regulatory Affairs Specialists focus on ensuring compliance with regulations and managing submissions to authorities. Both roles often collaborate but serve distinct functions in bringing a drug to market.

What are the most commonly searched types of Cmc jobs in California? The most popular types of Cmc jobs in California are:
What are popular job titles related to Cmc jobs in California? For Cmc jobs in California, the most frequently searched job titles are:
What job categories do people searching Cmc jobs in California look for? The top searched job categories for Cmc jobs in California are:
What cities in California are hiring for Cmc jobs? Cities in California with the most Cmc job openings:
Cmc jobs near you
Infographic showing various Cmc job openings in California as of July 2026, with employment types broken down into 100% Full Time. Highlights an 100% In-person job distribution, with an average salary of $64,135 per year, or $30.8 per hour.

Director, CMC Regulatory

Corvus Pharmaceutical

South San Francisco, CA • On-site

Full-time

Posted 15 days ago

Job description

Corvus Pharmaceutical is a clinical-stage biopharmaceutical company developing novel therapies with the potential to significantly improve the treatment of immune diseases and cancer.  Our lead program, Soquelitnib, is a first-in-class, oral therapy that selectively inhibits ITK to modulate and control parallel signaling pathways in the immune system.

Reporting to the Vice President of Regulatory Affairs, the Director of Regulatory Affairs CMC will serve as a key member of the Regulatory organization, responsible for developing and executing global Chemistry, Manufacturi ng, and Controls (CMC) regulatory strategies for clinical-stage small molecule programs. 
This individual will partner cross-functionally with CMC, Technical Operations, Quality, and Clinical teams to ensure timely, compliant, and high-quality regulatory submissions and lifecycle management activities.

ROLE AND RESPONSIBILITIES

• Develop and execute global CMC regulatory strategies across all phases of development (IND/CTA through 

NDA/MAA and lifecycle management)

• Provide strategic input and regulatory guidance on manufacturing changes, comparability approaches, and 

control strategies

• Anticipate regulatory risks and propose mitigation strategies aligned with agency expectations (e.g. FDA, 

EMA, Health Canada, PMDA)

• Lead preparation and authorship of CMC sections (Module 2.3, 3) for: INDs/CTAs/Amendments

• Lead preparation of CMC Briefing documents and health authority interactions

• NDA/MAA and supplements/variations preparation and submissions

• Ensure alignment of CMC documentation with overall regulatory strategy and program timelines

• Oversee document quality, consistency, and compliance with global regulatory requirements

• Represent regulatory in change control assessments

• Support inspection readiness activities in collaboration with Quality and Manufacturing teams

QUALIFICATIONS AND EDUCATION REQUIREMENTS

• Bachelor’s degree in life sciences or related field required; advanced degree (MS, PhD, PharmD) preferred

• Minimum of 10+ years of regulatory affairs experience in biotech/pharma

PREFERRED SKILLS

• Experience supporting small molecules required (familiarity with additional modalities

desirable).

• Experience with IND/CTA, NDA/MAA compilation and submissions.

• Deep knowledge of CMC development for small molecules, Module 3 structure and 

expectations, and comparability and change management strategies.

• Familiarity with global regulatory frameworks (FDA, EMA, ICH guidelines)

• Proven ability to operate effectively in a small, fast-paced biotech environment

• Strong cross-functional leadership and influencing skills without direct authority

• Excellent written and verbal communication skills, with the ability to translate complex CMC topics into clear regulatory strategies

Salary Range: $230,000 to $270,000

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