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Cmc Reviewer Jobs (NOW HIRING)

Staffingine LLC

CMC Writer

Paramus, NJ · On-site

Authoring and review of CMC submission components and documentation in CTD to support regulatory submissions for mainly EU (IMPD and MAA) and US-FDA (IND, BLA or NDA) submissions * Ensure completion ...

Staffingine LLC

CMC Writer

Paramus, NJ · On-site

Author and review CMC sections of regulatory submissions (IND, NDA, BLA, MAA, IMPD) in CTD/eCTD format. * Manage timelines and deliverables for CMC workstreams, ensuring alignment with project goals.

TekWissen LLC

CMC Writer

Paramus, NJ · On-site

$45 - $50/hr

Authoring and review of CMC submission components and documentation in CTD to support regulatory submissions for mainly EU (IMPD and MAA) and US-FDA (IND, BLA or NDA) submissions * Ensure completion ...

Atomic

CMC Consultant

Position Overview: Indomo is seeking an experienced CMC consultant to execute Chemistry ... Review deliverables, ensure timelines are met, and mitigate technical risks. * Advise on quality ...

Legend Biotech US

Manager, Regulatory CMC

Somerset, NJ · Hybrid

Author, review, and maintain high-quality CMC regulatory documentation to support global development, registration, and commercialization activities, ensuring compliance with applicable regulatory ...

Scorpion Therapeutics

CMC dossier leader

Waltham, MA · On-site

Lead CMC sub team (Dossier Subgroup/Submission Taskforce) for authoring, review, comment resolution, and approval of CMC dossiers. * Ensure timely delivery of CMC dossiers for regulatory submissions ...

ImmunEdge, Inc

Head of CMC

Redwood City, CA · On-site

Run stage-gate reviews, maintain the risk register with mitigations and scenario plans, and manage ... Regulatory CMC & Health Authority Strategy #J-18808-Ljbffr

ImmunEdge, Inc

Head of CMC

Redwood City, CA · On-site

$277K - $416K/yr

Run stage-gate reviews, maintain the risk register with mitigations and scenario plans, and manage ... Forecast and control the CMC budget, statements of work, and change orders. * External ...

Immunedge Inc

Head of CMC

Redwood City, CA · On-site

$277K - $416K/yr

Run stage-gate reviews, maintain the risk register with mitigations and scenario plans, and manage ... Forecast and control the CMC budget, statements of work, and change orders. * External ...

Rhythm Pharmaceuticals

Director, Regulatory CMC

Boston, MA · On-site

$182K - $275K/yr

Author, compile, review, and finalize high-quality CMC regulatory documents and submissions, including core dossiers, INDs, IMPDs, MAAs, BLAs, variations, and annual reports, in collaboration with ...

Rhythm Pharmaceuticals

Director, Regulatory CMC

Boston, MA · On-site

$182K - $275K/yr

Author, compile, review, and finalize high-quality CMC regulatory documents and submissions, including core dossiers, INDs, IMPDs, MAAs, BLAs, variations, and annual reports, in collaboration with ...

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 ...

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Cmc Reviewer information

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$10

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How much do cmc reviewer jobs pay per hour?

As of Sep 13, 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 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 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.

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 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.

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Cmc Reviewer jobs near you
Infographic showing various Cmc Reviewer job openings in the United States as of September 2026, with employment types broken down into 67% Full Time, and 33% Part Time. Highlights an 67% In-person, and 33% Remote job distribution, with an average salary of $62,159 per year, or $29.9 per hour.

CMC Writer

Paramus, NJ • On-site

Staffingine LLC
Recruiting and Staffing Services • 51 - 200 employees
Learn more about Staffingine LLCexternal

Contractor

Re-posted 29 days ago

Job description

Job Title: CMC Writer
Job Location: Paramus, NJ
Job Type: Contract

Job Description:

  • Authors a range of clinical documents, including regulatory documents following defined templates, NDA/MAA CTD submission documents, investigator brochures, briefing documents, and responses to regulatory authority questions.
  • Support the coordination and preparation of timely CMC file for AR/DSUR/RTQ submissions
  • Authoring and review of CMC submission components and documentation in CTD to support regulatory submissions for mainly EU (IMPD and MAA) and US-FDA (IND, BLA or NDA) submissions
  • Ensure completion of high-quality submissions, following regulatory guidelines and internal processes within timelines.
  • Obtain information from other departments regarding regulatory submissions or documentation to support CMC submissions.
  • Assess and communicate potential regulatory risks and propose mitigation strategies
  • Understands, interprets and advises teams on regulations, guidelines, procedures and policies relating to manufacture and control of medicinal products, to expedite the submission, and review and approval of applications.
  • Identify, communicate and escalate potential CMC regulatory issues, as needed
  • Help establish regulatory CMC submission processes and procedures.
  • Familiar with eCTD format submission files
  • Project management skill is plus
  • Author and review CMC sections of regulatory submissions, including IND, NDA, and MAA applications.
  • Ensure documents align with FDA, EMA, and ICH regulatory requirements.
  • Work closely with scientists, regulatory affairs teams, and manufacturing experts to gather accurate data.
  • Maintain consistency, clarity, and accuracy in technical writing.
  • Help establish regulatory CMC submission processes and procedures.