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Cmc Reviewer Jobs (NOW HIRING)

Madrigal

Director, Regulatory Affairs CMC

Waltham, MA · On-site

$207 - $253/hr

Guide the team in defining and driving the strategy for CMC regulatory dossier content and review this content for conformance with Health Authority requirements. * Represent the Madrigal Regulatory ...

CSL

GRA CMC Specialist

King Of Prussia, PA · On-site

Ensuring operational alignment of Global Regulatory Affairs CMC activities and processes with R&D ... Proven expertise in authoring, reviewing, and managing regulatory submissions at both federal and ...

BeiGene, Inc.

Executive Director, Regulatory Affairs, CMC

$153K - $202K/yr

Review and approve Regulatory CMC documentation, including submissions, responses, and internal procedures, within the Regulatory Information Management (RIM) system. * Lead or oversee Regulatory CMC ...

AbbVie

Director, ADC CMC Sciences

Waltham, MA · On-site

$160K/yr

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 ...

Vaxcyte

Associate Director, Regulatory CMC

San Carlos, CA · On-site

$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 ...

CSL

GRA CMC Specialist

King Of Prussia, PA

Ensuring operational alignment of Global Regulatory Affairs CMC activities and processes with R&D ... Proven expertise in authoring, reviewing, and managing regulatory submissions at both federal and ...

Vrtx

Director, Regulatory Affairs CMC

Boston, MA · Hybrid

$190K - $285K/yr

Oversees preparation, review, and approval of CMC content for global regulatory submissions. * Provides strategic leadership for Health Authority interactions and negotiations. * Leads and develops ...

CSL

GRA CMC Specialist

King Of Prussia, PA · On-site

Ensuring operational alignment of Global Regulatory Affairs CMC activities and processes with R&D ... Proven expertise in authoring, reviewing, and managing regulatory submissions at both federal and ...

CSL

GRA CMC Specialist

King Of Prussia, PA · On-site

Ensuring operational alignment of Global Regulatory Affairs CMC activities and processes with R&D ... Proven expertise in authoring, reviewing, and managing regulatory submissions at both federal and ...

Allergan

Director, RA CMC

Irvine, CA · On-site

$140 - $180/hr

Prepares CMC regulatory strategies that enable first pass approvals. Develops and manages content ... Reviews and revises regulatory submission documentation to effectively present data and strategy to ...

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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 Affairs - CMC

Orano

Plano, TX • On-site

Full-time

Posted 18 days ago

Job description

Description
Orano Med Theranostics
Orano Med has developed new processes for producing high-purity lead-212, a rare radioactive isotope. Lead-212 is currently at the heart of promising research projects in nuclear medicine to develop new treatments against cancer. The innovative approach, known as targeted alpha therapy (TAT), recognizes and destroys cancer cells while limiting the impact on nearby healthy cells.
The Associate Director, Regulatory Affairs - CMC will be responsible for leading the global regulatory CMC strategy for product development and registration, and for the preparation of CMC dossier in the expanding field of radiopharmaceuticals in the US and in EU.
This global role will join the regulatory team and will report directly to the Head of Regulatory Affairs. The person will work cross-functionally with the CMC team and the manufacturing sites to lead the regulatory CMC strategy and the preparation of regulatory CMC documentation and submissions in adherence to relevant regulatory requirements and company standards.
Key Responsibilities:
  • Leads the development and preparation of global (US and EU) CMC-related submission documents for the pipeline of radiopharmaceutical products. This includes authoring, review and consolidation to deliver high-quality documents. Working in close collaboration with the CMC team (Manufacturing, Quality, R&D process), the regulatory CMC lead will collect technical data from relevant partners to write regulatory CMC documents and support the overall project goals.
  • Develops robust global regulatory CMC strategies for the pipeline of radiopharmaceutical products. Identifies risks and proposes risk mitigation to enable successful regulatory submissions and approvals. Aligns within Regulatory Affairs to enable one regulatory voice.
  • The regulatory submissions include but are not limited to the M3/CMC section of INDs/CTAs (IMPD-Q), DMF/ASMF, briefing documents, response to queries, Orphan Drug Applications, and annual reports.
  • Manages regulatory CMC agency interactions and meetings.
  • Meets current regulatory standards and achieves timely submissions, to enable approval on the first review cycle. Effectively interprets and applies regulatory CMC guidance. Provides recommendations and solutions to cross-functional teams and key stakeholders.
  • Works with the Regulatory Operations vendor to coordinate publishing and submission for CMC dossiers (eCTD)
  • Leads or contributes to the development of internal processes to improve the regulatory and CMC ways of working.
  • Remains current on CMC regulatory intelligence.

Requirements
All candidates must meet the following minimum requirements in order to be considered for this opportunity. Candidates who exceed minimum qualifications may be considered for a higher-level position.
Minimum Qualifications:
  • Bachelor's degree in a scientific discipline. Advanced degree (MS, PharmD or PhD) is a plus.
  • A minimum of 8 years Regulatory CMC experience and/or CMC technical writing experience in a pharmaceutical or biotechnology environment including injectables.

Required Skills and Competencies:
  • Demonstrated hands-on experience in pharmaceutical development, registration in the US and/or EU, and interaction with health authorities. Demonstrated experience in preparing regulatory submissions, including IND/CTA, NDA/MAA, DMF/ASMF, briefing documents, and response to agency questions.
  • Technical knowledge in small molecules with experience in translating to a regulatory document. Knowledge of radiopharmaceuticals and innovative platforms is a plus.
  • Knowledge of relevant global CMC regulations and guidelines (ICH, US, EU)
  • Experience within a GMP environment with a firm understanding of industry regulations and best practices
  • Ability to understand and interpret complex scientific issues across multiple projects as it relates to regulatory requirements and strategy.
  • Excellent verbal and written communication skills. Able to defend the regulatory CMC position while maintaining positive professional relationships
  • Proactive, able to work independently and collaboratively in a fast-paced emerging field
  • Analytical thinker with good problem-solving skills and the capacity to adapt to a field with relatively few guidelines available.
  • Excellent planning and organization skills including the ability to support multiple projects.
  • Proficiency with Microsoft Office.
  • Travel requirements: Up to 10% travel

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