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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 * Authors a range of clinical documents, including regulatory documents following defined templates, NDA/MAA CTD submission documents ...

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 ...

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 ...

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 ...

Retro

CMC Regulatory Lead

Redwood City, CA · On-site

$200K - $240K/yr

We're hiring an experienced CMC Regulatory Lead to own the strategy and operations for our Chemistry, Manufacturing, and Controls (CMC) regulatory work. As one of the earliest members of the ...

Retro

CMC Regulatory Lead

Redwood City, CA · On-site

$200K - $240K/yr

We're hiring an experienced CMC Regulatory Lead to own the strategy and operations for our Chemistry, Manufacturing, and Controls (CMC) regulatory work. As one of the earliest members of the ...

Retro

CMC Regulatory Lead

Redwood City, CA

$200K - $240K/yr

We're hiring an experienced CMC Regulatory Lead to own the strategy and operations for our Chemistry, Manufacturing, and Controls (CMC) regulatory work. As one of the earliest members of the ...

Telix Pharmaceuticals (AMER)

OR · On-site

The CMC Program Lead will be responsible for coordinating and delivering CMC activities in line with project requirements and company goals for assigned CMC development programs (Precision Medicine ...

Rho Inc

CMC Regulatory Strategist

$153K - $202K/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 ...

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 ...

Dyne Therapeutics

Director, Regulatory CMC

Waltham, MA · On-site

$161K - $213K/yr

Serve as the CMC regulatory strategist and program leader, proactively identifying regulatory risks, opportunities, and mitigation strategies in alignment with development and commercialization ...

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 ...

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 ...

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 ...

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Cmc information

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$13

$31

$67

How much do cmc jobs pay per hour?

As of Jul 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 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
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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 2% As Needed, 82% Full Time, 14% Part Time, and 2% Contract. Highlights an 91% Physical, 2% Hybrid, and 7% 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

Re-posted 26 days ago

Job description

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

Job Description:

  • Authors a range of clinical documents, including regulatory documents following defined templates, NDA/MAA CTD submission documents, investigator brochures, briefing documents, and responses to regulatory authority questions.
  • Support the coordination and preparation of timely CMC file for AR/DSUR/RTQ submissions
  • Authoring and review of CMC submission components and documentation in CTD to support regulatory submissions for mainly EU (IMPD and MAA) and US-FDA (IND, BLA or NDA) submissions
  • Ensure completion of high-quality submissions, following regulatory guidelines and internal processes within timelines.
  • Obtain information from other departments regarding regulatory submissions or documentation to support CMC submissions.
  • Assess and communicate potential regulatory risks and propose mitigation strategies
  • Understands, interprets and advises teams on regulations, guidelines, procedures and policies relating to manufacture and control of medicinal products, to expedite the submission, and review and approval of applications.
  • Identify, communicate and escalate potential CMC regulatory issues, as needed
  • Help establish regulatory CMC submission processes and procedures.
  • Familiar with eCTD format submission files
  • Project management skill is plus
  • Author and review CMC sections of regulatory submissions, including IND, NDA, and MAA applications.
  • Ensure documents align with FDA, EMA, and ICH regulatory requirements.
  • Work closely with scientists, regulatory affairs teams, and manufacturing experts to gather accurate data.
  • Maintain consistency, clarity, and accuracy in technical writing.
  • Help establish regulatory CMC submission processes and procedures.