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Cmc Jobs (NOW HIRING)

Staffingine LLC

CMC Writer

Paramus, NJ · On-site

CMC Writer Job Location: Paramus, NJ Job Type: Contract * Author and review CMC sections of regulatory submissions (IND, NDA, BLA, MAA, IMPD) in CTD/eCTD format. * Manage timelines and deliverables ...

Staffingine LLC

CMC Writer

Paramus, NJ · On-site

CMC Writer Job Location: Paramus, NJ Job Type: Contract * Authors a range of clinical documents, including regulatory documents following defined templates, NDA/MAA CTD submission documents ...

Atomic

CMC Consultant

Indomo is seeking an experienced CMC consultant to execute Chemistry, Manufacturing & Controls (CMC) strategy and operations on a fractional basis. This individual will play a critical role in ...

Stoke Therapeutics

Director, CMC Lead

Bedford, MA

The CMC Lead role is a highly visible matrix team leader that provides strategic and technical leadership within CMC, while representing CMC on cross-functional Program Teams. The ideal candidate ...

TekWissen LLC

CMC Writer

Paramus, NJ · On-site

$45 - $50/hr

CMC Writer Location: Paramus, New Jersey, 07652 Job Type: Contract Duration: 6 Months Work Type: Hybrid * A Pharmaceutical CMC (Chemistry, Manufacturing, and Controls) Writer plays a crucial role in ...

Stoke Therapeutics

Director, CMC Lead

Bedford, MA · On-site +1

The CMC Lead role is a highly visible matrix team leader that provides strategic and technical leadership within CMC, while representing CMC on cross-functional Program Teams. The ideal candidate ...

Edgewater Federal Solutions, Inc.

Be Seen First

CMC Expert (Remote)

Washington, DC · On-site

$185K - $190K/yr

This role requires expertise in deploying, configuring, and operating Strategy CMC within a Red Hat OpenShift container platform. Candidates whose experience is limited to OpenShift administration ...

Dyne Therapeutics

Director, Regulatory CMC

Waltham, MA · On-site

$161K - $213K/yr

The Director, Regulatory Affairs - Chemistry, Manufacturing, and Controls (CMC) is responsible for defining and executing global CMC regulatory strategies for Dyne programs across all stages 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 Global Regulatory Affairs and within Global Operations business needs. This role promotes strong ...

Us tech Solutions

CMC Regulatory Manager

Morristown, NJ · On-site

CMC Manager Duration: 12 Months Location: Morristown, NJ 07962 The CMC Documentation Team is responsible for the development of Chemistry, Manufacturing and Control (Module 3) documentation for the ...

Icon plc

CMC Project Manager

Belgium, WI

CMC Project Manager ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster. As a values-driven ...

Atomic

Drug CMC Lead

$150K - $215K/yr

We are seeking a versatile and experienced CMC Lead to lead our drug development and manufacturing. Position Overview: Reporting to the CEO, you will own and execute the Chemistry, Manufacturing ...

Rhythm Pharmaceuticals

Director, Regulatory CMC

Boston, MA · On-site

$182K - $275K/yr

This individual contributor role will execute regulatory CMC plans and support implementation of filing strategies for assigned programs. As part of the growing and dynamic regulatory affairs team ...

CSL

GRA CMC Specialist

King Of Prussia, PA

Ensuring operational alignment of Global Regulatory Affairs CMC activities and processes with R&D Global Regulatory Affairs and within Global Operations business needs. This role promotes strong ...

CSL

GRA CMC Specialist

King Of Prussia, PA · On-site

Ensuring operational alignment of Global Regulatory Affairs CMC activities and processes with R&D Global Regulatory Affairs and within Global Operations business needs. This role promotes strong ...

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Cmc information

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$13

$31

$67

How much do cmc jobs pay per hour?

As of Aug 3, 2026, the average hourly pay for cmc in the United States is $31.24, according to ZipRecruiter salary data. Most workers in this role earn between $19.23 and $36.54 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.

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Cmc jobs near you
Infographic showing various Cmc job openings in the United States as of July 2026, with employment types broken down into 1% As Needed, 82% Full Time, 14% Part Time, 2% Contract, and 1% Nights. Highlights an 92% Physical, 3% Hybrid, and 5% Remote job distribution, with an average salary of $64,986 per year, or $31.2 per hour.

CMC Writer

Staffingine LLC

Paramus, NJ • On-site

Contractor

Re-posted 17 days ago

Job description

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

Job Description:  

  • 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. 

  • Prepare and coordinate CMC documentation for AR, DSUR, and responses to regulatory authority questions. 

  • Ensure compliance with FDA, EMA, and ICH guidelines and internal processes. 

  • Collaborate with cross-functional teams to gather accurate technical information. 

  • Identify and communicate potential regulatory risks; propose mitigation strategies. 

  • Support process improvement initiatives for CMC submission workflows.