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Cmc Jobs (NOW HIRING)

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 ...

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 dossier leader * Location: Framingham, MA About the job Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and ...

The CMC Lead will develop, execute, and maintain the integrated CMC strategy and plan grounded in Quality by Design (QbD) principles, aligned to Stage-Gate requirements, spanning Drug Substance, Drug ...

CMC dossier leader * Location: Framingham, MA About the job Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and ...

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 ...

Overview The Director of CMC is responsible for day-to-day leadership and execution of Critical Innovations' Chemistry, Manufacturing, and Controls (CMC) activities, with primary oversight over ...

Job Title: CMC Project Leader Location: Framingham, MA About the Job As the CMC Project Lead within our Cluster Mammalian Project team, you'll be accountable for the CMC project activities of ...

Job Title: CMC Project Leader Location: Framingham, MA About the Job As the CMC Project Lead within our Cluster Mammalian Project team, you'll be accountable for the CMC project activities of ...

CMC dossier leader * Location: Framingham, MA About the job Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and ...

Director of CMC

El Segundo, CA · On-site

$200K - $230K/yr

This role will be responsible for all CMC activities across the external drug development pipeline of Varda's partners. Reporting to the VP, Pharma Program Management), this position requires ...

CMC dossier leader * Location: Framingham, MA About the job Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and ...

Job Title: CMC Project Leader Location: Framingham, MA About the Job As the CMC Project Lead within our Cluster Mammalian Project team, you'll be accountable for the CMC project activities of ...

Job Title: CMC Project Leader Location: Framingham, MA About the Job As the CMC Project Lead within our Cluster Mammalian Project team, you'll be accountable for the CMC project activities of ...

CMC Regulatory Strategist

$153.50K - $202.70K/yr

As a CMC Regulatory Strategist, you will have the opportunity to provide strategic and tactical leadership to Rho clients and project teams in support of our clients' interdisciplinary pharmaceutical ...

Director of CMC

El Segundo, CA · On-site

$200K - $230K/yr

This role will be responsible for all CMC activities across the external drug development pipeline of Varda's partners. Reporting to the VP, Pharma Program Management), this position requires ...

You will translate CMC strategy into actionable, integrated plans that enable timely clinical and regulatory progress. This role is highly cross-functional and requires close collaboration with ...

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Cmc information

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How much do cmc jobs pay per hour?

As of May 30, 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.

More about Cmc jobs
What cities are hiring for Cmc jobs? Cities with the most Cmc job openings:
What are the most commonly searched types of Cmc jobs? The most popular types of Cmc jobs are:
What states have the most Cmc jobs? States with the most job openings for Cmc jobs include:
Infographic showing various Cmc job openings in the United States as of May 2026, with employment types broken down into 2% As Needed, 75% Full Time, 15% Part Time, and 8% Contract. 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

CMC Writer

Staffingine LLC

Paramus, NJ • On-site

Contractor

Posted 12 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.