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Cmc Reviewer Jobs (NOW HIRING)

Intuitive

Project Manager, CMC

Sunnyvale, CA · On-site

The role translates CMC strategies and technical decisions into coordinated cross-functional ... business reviews and operational follow-up across internal functions. * Drive adoption of ...

BeiGene USA

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 ...

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 ...

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 ...

Korsana Biosciences, Inc.

VP, CMC

Waltham, MA · On-site

$300K - $340K/yr

Author and review CMC sections, Module 3 Quality, of global regulatory submissions (IND/IMPD/BLA/MAA). * Ensure product supply for clinical and preclinical studies * Establish and maintain an ...

Intuitive

Project Manager, CMC

Sunnyvale, CA · On-site

The role translates CMC strategies and technical decisions into coordinated cross-functional ... business reviews and operational follow-up across internal functions. * Drive adoption of ...

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 ...

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Cmc Reviewer information

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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.

Associate Director, CMC Regulatory Affairs

Paramus, NJ • On-site

NS Pharma Inc
Pharmaceutical and Medicine Manufacturing • 51 - 200 employees
Learn more about NS Pharma Incexternal

$170K - $190K/yr

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Re-posted 16 days ago

Key responsibilities

  • Plan and execute CMC regulatory activities including IND M3/IMPD-Quality for investigational products, and NDAs/BLAs and post-approval supplements/variations for marketed products.

  • Lead and coordinate CMC-related FDA meetings, including meeting strategy, material preparation, internal alignment, and submission logistics.

  • Coordinate and oversee the preparation and review of CMC regulatory documents, including scientific/technical input for full regulatory compliance.

Job description

NS Pharma is a highly focused, research-driven biopharmaceutical company working in rare diseases.  We’re exploring the potential of cutting-edge science as a subsidiary of Nippon Shinyaku Co., Ltd. In Japan

Summary:

CMC Regulatory Affairs develops and executes CMC regulatory strategies for investigational and marketed products in close collaboration with regulatory leadership, with a primary focus on U.S. Health Authority (FDA) interactions.

This role coordinates and oversees the preparation and review of CMC-related regulatory documents, supports Health Authority meetings and follow-up commitments, and partners closely with cross-functional teams in the U.S. (NS Pharma) and Japan (Nippon Shinyaku HQ) to ensure global alignment and timely issue resolution.

This is a hybrid role that requires two days in the Paramus, NJ office.

Responsibilities:

  • Plan and execute CMC regulatory activities including IND M3/IMPD-Quality for investigational products, and NDAs/BLAs and post-approval supplements/variations for marketed products.
  • Lead and coordinate CMC-related FDA meetings (e.g., pre-IND; Type A, B, and C; and NDA/BLA-related meetings) in collaboration with Regulatory Affairs Strategy, including meeting strategy, material preparation, internal alignment, and submission logistics.
  • Coordinate and oversee CMC dossier readiness and the preparation/review of CMC regulatory deliverables in eCTD format, including scientific/technical input for full regulatory compliance. 
  • Serve as the day-to-day CMC regulatory liaison for timely submission-ready of CMC-document through IND/CTA/NDA/BLA.
  • Coordinate and support responses to CMC-related Health Authority information requests/questions in alignment with cross-functional stakeholders.
  • Manage external CMC regulatory expert consultations (consultants/contractors) including selection support, deliverable expectations, quality review, and timeline/budget oversight.
  • Partner with cross-functional teams (CMC, QA, Clinical, Nonclinical, Project Management, etc.) to align regulatory strategy and execution.
  • Establish regulatory classification and filing strategy for CMC changes in manufacturing, analytical testing, and supply chain throughout the product life cycle.
  • Ensure consistency and traceability of CMC regulatory positions across key documents (e.g., Module 2 QoS and Module 3 content).
  • Maintain CMC regulatory documentation controls and inspection/audit readiness (e.g., version control, document traceability, decision logs, and submission trackers) to support timely, high-quality deliverables.
  • Monitor and communicate evolving global regulatory requirements and guidance (e.g., ICH, FDA, EU), and proactively assess impacts and risks, and take required actions for programs.
  • Support operational regulatory activities as needed, including coordination of cross-functional meetings, maintenance of submission trackers, and documentation of decisions and action items.

Experience (Required):

  • Strong knowledge of U.S. FDA CMC regulatory requirements.
  • Strong knowledge of ICH Quality guidelines
  • Excellent English communication skills (written and verbal) suitable for Health Authority interactions and regulatory documentation.
  • Working knowledge of CMC CTD/eCTD structure and the ability to ensure CMC content readiness and consistency.
  • Experience working effectively in a cross-functional team environment.

Preferred Qualifications:

  • Strong knowledge of GMP
  • Experience in rare disease 
  • Working understanding of EU regulatory requirements (EMA) and ability to support EU-related activities.
  • Demonstrated ability to develop and execute CMC regulatory strategy throughout the product lifecycle.
  • Excellent technical writing and editing skills for regulatory documentation and Health Authority correspondence (clear, consistent, defensible rationale). 
  • Strong organizational and project management skills, including prioritization, issue/risk tracking, attention to detail, and document control discipline (version control, traceability, decision documentation).

Education: 

  • A bachelor’s degree in pharmacy, chemistry, or a related scientific discipline, or equivalent experience is required. MSc or PhD preferred.
  • Typically, 8 – 10 years of experience in the CMC field of the pharmaceutical/biotechnology industry, including a minimum of 5 years of CMC regulatory affairs.
  • A minimum of one NDA/BLA and multiple IND/CTA is also preferred.

Compensation And Benefits:

NS Pharma employees embrace our Mission to Help People Lead Healthier Happier Lives.   We pride ourselves in offering employees and their families a robust Compensation and Benefits package designed to meet their needs, on and off the job.

The annualized target salary range for this role is $170,000 to $190,000; actual salaries will vary and may be above or below this range depending on several factors, including experience, education, training, location, and merit.  

Other benefits include:

  • Medical, Dental & Vision Insurance, Basic and Voluntary Life and AD&D Insurance, Short- and Long-Term Disability Insurance, Flexible Spending Account, Health Savings Account, and Employee Assistance Programs
  • Discretionary Bonus Programs and Long-term Incentive Plan
  • Retirement Savings 401k with company match 
  • Generous Paid Time Off, Sick Time & Paid Holidays 
  • Career Development, Progression and Training 
  • Flexible Work Arrangement Programs
  • Paid Parental Leave
  • Year-End Paid Holiday Shutdown

Applications will be accepted until August 31, 2026, or until a candidate is hired. Applicants not hired will remain in our Talent community for future opportunity consideration. Thank you for your interest in NS Pharma.

NS Pharma is an EEO employer.