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Cmc Reviewer Jobs (NOW HIRING)

Vaxcyte

Associate Director, Regulatory CMC

San Carlos, CA · On-site +1

$180K - $210K/yr

Leads the preparation and review of CMC sections of global regulatory submissions, as well as the interactions and responses with regulatory agencies * Member of technical development teams which ...

Altimmune

CMC Director, Regulatory Affairs

Morristown, NJ

$154K - $204K/yr

Participates in the development, review, and implementation of departmental SOPs and processes. Job ... Experience in CMC regulatory lifecycle management, including compiling, reviewing, and managing CMC ...

BrainChild Bio

Director, Regulatory Affairs, CMC

$153K - $202K/yr

Author, review, and coordinate Module 3 (M3) content, ensuring consistency, quality, and alignment ... Proactively identify CMC regulatory risks, anticipate Health Authority questions, and develop of ...

Moderna Therapeutics

Director, CMC Stability

Norwood, MA · On-site

$167 - $300.70/hr

The Role CMC is seeking a dynamic and experienced Director, CMC Stability to lead an end-to-end ... Oversee authoring and review of stability sections for regulatory submissions, briefing packages ...

AbbVie

Director, ADC CMC Sciences

Waltham, MA

Review submissions through registration of the product as well as post-approval life-cycle ... CMC development experience through IND and/or NDA/MAA. Experience leading multiple CMC project ...

AbbVie

Director, ADC CMC Sciences

Waltham, MA · On-site

Review submissions through registration of the product as well as post-approval life-cycle ... CMC development experience through IND and/or NDA/MAA. Experience leading multiple CMC project ...

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Cmc Reviewer information

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How much do cmc reviewer jobs pay per hour?

As of Aug 15, 2026, the average hourly pay for cmc reviewer in the United States is $29.88, according to ZipRecruiter salary data. Most workers in this role earn between $22.60 and $36.54 per hour, depending on experience, location, and employer.

What is the difference between Cmc Reviewer vs Cmc Associate?

AspectCmc ReviewerCmc Associate
Required CredentialsBachelor's degree, often in life sciences or chemistry; relevant experienceSimilar educational background; entry-level or junior role
Work EnvironmentRegulatory or pharmaceutical companies, quality assurance teamsSame industry, often in early career stages
Employer & Industry UsageUsed in biotech, pharma, and regulatory sectors for review rolesCommonly a starting position in CMC departments
Comparison Search IntentUnderstanding seniority and responsibilitiesEntry-level role, learning responsibilities

The main difference between a Cmc Reviewer and a Cmc Associate lies in experience and responsibility. Cmc Reviewers typically have more experience and are responsible for critically evaluating CMC documentation, while Cmc Associates are often entry-level, supporting review processes. Both roles require similar educational backgrounds and are integral to pharmaceutical and biotech industries.

What is a CMC reviewer?

CMC Reviewers are professionals who evaluate the Chemistry, Manufacturing, and Controls (CMC) sections of regulatory submissions for pharmaceuticals and biologics. Their main responsibility is to ensure that products are manufactured consistently and meet quality standards required by regulatory agencies such as the FDA. They assess data on product composition, manufacturing processes, quality control, and stability to ensure compliance with regulations. CMC Reviewers play a critical role in the drug approval process by helping to ensure the safety, efficacy, and quality of new therapies.

What are some common challenges faced by CMC reviewers in coordinating with cross-functional teams during the regulatory submission process?

CMC Reviewers often encounter challenges in aligning documentation and data from various departments such as manufacturing, quality control, and research. Differences in terminology, documentation standards, and timelines can cause delays or inconsistencies in submissions. Effective communication, proactive project management, and a strong understanding of regulatory requirements are crucial for ensuring all contributions meet submission standards and deadlines. Building strong relationships with stakeholders and establishing clear documentation processes can help mitigate these challenges.

What are the key skills and qualifications needed to thrive as a CMC reviewer?

To thrive as a CMC Reviewer, you need in-depth knowledge of chemistry, manufacturing, and controls (CMC) regulations, as well as a degree in pharmacy, chemistry, or a related scientific field. Familiarity with regulatory submission systems like eCTD, and experience with ICH guidelines and FDA/EMA standards, are typically required. Strong attention to detail, critical thinking, and effective communication skills help reviewers assess complex data and collaborate with cross-functional teams. These capabilities ensure regulatory compliance and product quality, facilitating timely drug approvals and patient safety.
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Cmc Reviewer jobs near you
Infographic showing various Cmc Reviewer job openings in the United States as of August 2026, with employment types broken down into 78% Full Time, 16% Part Time, and 6% Contract. Highlights an 53% Physical, 3% Hybrid, and 44% Remote job distribution, with an average salary of $62,159 per year, or $29.9 per hour.

Associate Director, Regulatory CMC

Vaxcyte

San Carlos, CA • On-site, Remote

$180K - $210K/yr

Full-time

Re-posted 19 days ago

Job description

Summary:

A hands-on role providing both strategic and operational activities. This role develops and executes multi-product global regulatory CMC strategies for investigational products and leads the preparation and filing of regulatory CMC submissions. Manages interactions with Health Authorities for CMC topics. 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 regulatory surveillance and communicates new/changing regulations.  

Essential Functions:

  • Leads the preparation and review of CMC sections of global regulatory submissions, as well as the interactions and responses with regulatory agencies
  • Member of technical development teams which require experienced interpretation of applicable EMA/FDA/ICH/Global regulations to ensure CMC compliance
  • Defines CMC content (data and documentation) requirements for regulatory submissions and compiles/reviews this content for conformance with established requirements
  • Provides CMC regulatory guidance to cross-functional teams and key stakeholders
  • Manages regulatory assessment and guidance on product compliance topics including change controls, deviations, and GMP investigations throughout development
  • Leads projects with cross-functional teams and acts as the primary regulatory CMC contact for assigned products and projects
  • Represents company in Health Authority meetings and leads or supports CMC preparation activities for meetings with Health Authorities on CMC related matters
  • Stays abreast of current and evolving regulatory CMC requirements, applies this knowledge to assigned projects, and shares knowledge and experience with others to support their development
  • Participates in the design, development and implementation of department strategies, providing recommendations in area of expertise

Requirements:

Bachelor's Degree in a scientific discipline (e.g. Biology, Chemistry, Pharmacy, Regulatory Affairs for Drugs, Biologics or Medical Devices). Minimum 10 years of experience working in vaccine or biotech industry, or in a related field, or the equivalent combination of education and experience. Other combinations of education and/or experience may be considered.

  • Prior experience preparing/authoring CMC DS sections:
    • BLA highly preferred.
    • Post-approval supplements/variations highly preferred.
    • INDs/IMPDs.
  • Prior development or manufacturing experience is a plus.
  • Computer software skills (LIMS, SAP, TrackWise, Veeva will be used).
  • Ability to meet multiple deadlines across a variety of projects/programs, with a high degree of accuracy and efficiency.
  • Excellent interpersonal skills to communicate difficult concepts.
  • Strategic thinking and strong problem-solving skills
  • Collaborates and communicates in an open, clear, complete, timely, and consistent manner
  • Strong sense of planning and prioritization, and the ability to work with all levels of management
  • Advanced knowledge in regulatory (FDA, EMA, Health Canada and ICH) guidelines
Reports to: Executive Director, CMC Regulatory
 
Location: San Carlos, CA / US Remote
 
Work Arrangement: Remote
 
Compensation:
The compensation package will be competitive and includes comprehensive benefits and an equity component.
 
Salary Range: $180,000 - $210,500 (SF Bay Area). Salary ranges for non-California locations may vary.
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About Vaxcyte

Sourced by ZipRecruiter

Industry

Biotechnology research and development

Company size

51 - 200 Employees

Headquarters location

San Carlos, CA, US

Year founded

2013

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