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Cmc Management Jobs (NOW HIRING)

TekWissen LLC

CMC Writer

Paramus, NJ · On-site

$45 - $50/hr

TekWissen is a global workforce management provider headquartered in Ann Arbor, Michigan that offers strategic talent solutions to our clients world-wide. Job Title: CMC Writer Location: Paramus, New ...

Stoke Therapeutics

Director, CMC Lead

Bedford, MA · On-site +1

Lead commercial product CMC lifecycle activities, including post-approval change management, product risk management, robustness improvements, and continuous improvement initiatives. * Drive the ...

Gilead

Manager, Regulatory Affairs CMC

Foster City, CA · On-site

$146K - $189K/yr

The CMC Regulatory Affairs Manager is responsible forsupporting the planning, coordination, and execution of CMC regulatory activities across global clinical and commercial programs. This role ...

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CMC Management information

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$81K

$118.8K

$157.5K

How much do cmc management jobs pay per year?

As of Aug 9, 2026, the average yearly pay for cmc management in the United States is $118,816.00, according to ZipRecruiter salary data. Most workers in this role earn between $94,000.00 and $132,000.00 per year, depending on experience, location, and employer.

What are some common challenges faced by professionals in CMC management, and how can they be addressed?

Professionals in CMC (Chemistry, Manufacturing, and Controls) Management often encounter challenges such as navigating complex regulatory requirements across different markets, ensuring consistent product quality during scale-up, and managing cross-functional communication between R&D, manufacturing, and regulatory teams. Addressing these challenges involves staying updated with evolving regulations, fostering strong collaboration among teams, and implementing robust quality management systems. Clear documentation and proactive risk management are also essential to overcome hurdles and ensure smooth product development and approval processes.

What is the difference between Cmc Management vs Cmc Specialist?

AspectCmc ManagementCmc Specialist
CredentialsBachelor's degree in life sciences, regulatory affairs, or related field; often requires experience in CMCSimilar educational background; may require specific certifications in regulatory affairs or quality assurance
Work EnvironmentOversees teams, manages projects, liaises with regulatory agenciesPerforms detailed review, documentation, and data analysis within the CMC process
Employer & Industry UsagePharmaceutical and biotech companies, regulatory agenciesPharmaceutical companies, contract research organizations, regulatory consulting firms

In summary, Cmc Management involves overseeing the entire CMC process, managing teams, and strategic planning, while Cmc Specialists focus on detailed technical work, data review, and documentation within the CMC scope. Both roles require relevant education and experience but differ in scope and responsibilities.

What is CMC management?

CMC management refers to the oversight and coordination of Chemistry, Manufacturing, and Controls (CMC) processes in the development and production of pharmaceuticals or biologics. This includes ensuring the quality, safety, and consistency of drugs by managing formulation, manufacturing protocols, analytical testing, and regulatory documentation. Effective CMC management is critical for meeting regulatory requirements and ensuring that products are safe and effective for patients. Professionals in this field work closely with research, development, quality assurance, and regulatory teams to bring new therapies to market.

What are the key skills and qualifications needed to thrive in CMC management?

To succeed in CMC (Chemistry, Manufacturing, and Controls) Management, you need a deep understanding of pharmaceutical development, regulatory requirements, and process optimization, often supported by a degree in chemistry, pharmacy, or related fields. Familiarity with quality management systems, regulatory submission platforms, and industry standards like ICH guidelines is crucial. Strong leadership, project management, and cross-functional communication skills help drive complex projects and effective collaboration. These capabilities ensure products meet safety, efficacy, and compliance standards throughout the drug development lifecycle.
More about CMC Management jobs
What cities are hiring for Cmc Management jobs? Cities with the most Cmc Management job openings:
What states have the most Cmc Management jobs? States with the most job openings for Cmc Management jobs include:
What job categories do people searching Cmc Management jobs look for? The top searched job categories for Cmc Management jobs are:
CMC Management jobs near you
Infographic showing various Cmc Management job openings in the United States as of August 2026, with employment types broken down into 1% As Needed, 83% Full Time, 13% Part Time, and 3% Contract. Highlights an 88% Physical, 2% Hybrid, and 10% Remote job distribution, with an average salary of $118,816 per year, or $57.1 per hour.

CMC Writer

TekWissen LLC

Paramus, NJ • On-site

$45 - $50/hr

Contractor

Re-posted 24 days ago

Job description

Overview:       
   
TekWissen is a global workforce management provider headquartered in Ann Arbor, Michigan that offers strategic talent solutions to our clients world-wide.    
   
Job Title: CMC Writer
Location: Paramus, New Jersey, 07652
Job Type: Contract       
Duration: 6 Months 
Work Type: Hybrid 
 
     
        
Job Description:     
  • A Pharmaceutical CMC (Chemistry, Manufacturing, and Controls) Writer plays a crucial role in regulatory submissions by preparing technical documents related to drug development, manufacturing, and quality control. 
  • 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 
Key Responsibilities 
  • Regulatory Documentation: Author and review CMC sections of regulatory submissions, including IND, NDA, and MAA applications. 
  • Compliance & Guidelines: Ensure documents align with FDA, EMA, and ICH regulatory requirements. 
  • Collaboration: Work closely with scientists, regulatory affairs teams, and manufacturing experts to gather accurate data. 
  • Quality Assurance: Maintain consistency, clarity, and accuracy in technical writing. 
  • Process Improvement: Help establish regulatory CMC submission processes and procedures. 
Requirement  
  • Strong technical writing, analytical, and regulatory knowledge.  
  • In the pharmaceutical industry and/or pharmaceutical development, broad knowledge and understanding of regulatory submissions, manufacturing processes, analytical methods, specifications, formulation development, test method validation, process validation, and packaging validation.   
  • Familiar with a variety of regulatory guidelines, technical processes, and procedures related to CMC development activities.  
  • Strong planning and organizational skills with demonstrated ability to deliver work on time.  
  • Excellent written and communication skills.   
  • Proficient in the use of Microsoft Office Suite including Word, Excel, Outlook 365 and Access. 
Qualifications 
  • Education: Bachelor's or advanced degree in chemistry, pharmaceutical sciences, or a related field. 
  • Experience: Prior experience in pharmaceutical or regulatory writing is preferred. 
TekWissen® Group is an equal opportunity employer supporting workforce diversity. 

TekWissen is an emerging global human capital, recruitment and IT services organization. Operating since 2009, we draw upon more than a decade of staffing experience to deliver critical talent acquisition solutions and IT engagements for our clients. We’re founded on a culture that is passionate about delivering tailored solutions, that create lasting partnerships.

Our global footprint covers six countries: United States, Canada, Australia, India, United Kingdom and the Philippines. This allows us to work in close partnership with organizations and manage everything from global talent needs with demanding resourcing strategies, to single sites with lower recruitment volumes.

TekWissen® is an equal opportunity employer supporting workplace diversity. 

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About TekWissen

Sourced by ZipRecruiter

TekWissen is an emerging global human capital, recruitment and IT services organization. Operating since 2009, we draw upon more than a decade of staffing experience to deliver critical talent acquisition solutions and IT engagements for our clients. We’re founded on a culture that is passionate about delivering tailored solutions, that create lasting partnerships.

Industry

Recruiting and staffing services

Company size

501 - 1,000 Employees

Headquarters location

Ann Arbor, MI, US

Year founded

2009

Social media

Twitter

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