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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 ...

CMC

$65K - $75K/yr

At CMC, it's the people inside our recycling centers, fabrication plants, manufacturing facilities, steel mills and offices that make us who we are as a company. Our success comes from finding ...

New

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 ...

Watton Hall

CMC Specialist

CMC Specialist The CMC Specialist in Regulatory Affairs is responsible for overseeing the Chemistry, Manufacturing, and Controls (CMC) aspects of regulatory submissions for pharmaceutical products.

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 ...

Scorpion Therapeutics

CMC dossier leader

Waltham, MA · On-site

Lead, coordinate, and manage CMC dossier preparation and development processes. * Drive alignment between dossier strategy and CMC activities to support expedited pathways to clinic and patients.

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 ...

Legend Biotech US

Manager, Regulatory CMC

Somerset, NJ · Hybrid

Legend Biotech is seeking a Manager, Regulatory CMC as part of the Regulatory Affairs team based in Somerset, NJ. Role Overview This position will support the development and execution of global CMC ...

Intuitive

Project Manager, CMC

Sunnyvale, CA · On-site

The role translates CMC strategies and technical decisions into coordinated cross-functional project plans that enable effective execution. Reporting to the Program Management & Operations ...

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Cmc information

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$13

$31

$67

How much do cmc jobs pay per hour?

As of Sep 13, 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 is a CMC?

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 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 the key skills and qualifications needed to thrive as a CMC 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 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 September 2026, with employment types broken down into 1% As Needed, 80% Full Time, 17% Part Time, and 2% Contract. Highlights an 82% Physical, 2% Hybrid, and 16% Remote job distribution, with an average salary of $64,986 per year, or $31.2 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:  

  • 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.