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Cmc Writer Jobs (NOW HIRING)

Revolution Medicines

Director, Global CMC Regulatory

$153K - $202K/yr

Effective written and verbal communication skills and interpersonal skills. * A collaborative, high ... CMC-related labeling impacts across regions. * Prior experience in oncology product ...

CSL

GRA CMC Specialist

King Of Prussia, PA · On-site

Ensuring operational alignment of Global Regulatory Affairs CMC activities and processes with R&D ... Exceptional oral and written communication skills, with a strong ability to negotiate, influence ...

Kardigan

Senior Director, CMC Regulatory

Princeton, NJ · On-site

$157K - $207K/yr

Head of CMC Regulatory Location: Princeton, NJ (onsite 4 days per week) Job Overview Kardigan is ... Strong interpersonal, communication (oral and written), and organizational skills * Ability to ...

CSL

GRA CMC Specialist

King Of Prussia, PA · On-site

Ensuring operational alignment of Global Regulatory Affairs CMC activities and processes with R&D ... Exceptional oral and written communication skills, with a strong ability to negotiate, influence ...

CSL

GRA CMC Specialist

King Of Prussia, PA · On-site

Ensuring operational alignment of Global Regulatory Affairs CMC activities and processes with R&D ... Exceptional oral and written communication skills, with a strong ability to negotiate, influence ...

RXinsider LTD.

$183K - $330K/yr

The CMC Product Lead ensures seamless integration of program strategy with the Target Product ... Demonstrates leadership quality, poise, flexibility, adaptability, and superb written and verbal ...

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Cmc Writer information

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How much do cmc writer jobs pay per hour?

As of Sep 14, 2026, the average hourly pay for cmc writer in the United States is $24.29, according to ZipRecruiter salary data. Most workers in this role earn between $18.51 and $27.88 per hour, depending on experience, location, and employer.

What is a CMC writer?

CMC Writers, or Chemistry, Manufacturing, and Controls Writers, are professionals who prepare documentation related to the manufacturing processes, quality control, and regulatory compliance of pharmaceutical products. They create and compile the CMC sections of regulatory submissions such as INDs, NDAs, and MAAs required by regulatory agencies like the FDA and EMA. Their work ensures that all technical information about drug substances and products is clearly documented, compliant with regulations, and ready for review by health authorities.

What are the key skills and qualifications needed to thrive as a CMC writer?

To thrive as a CMC Writer, you need a solid background in chemistry, pharmaceuticals, or life sciences, often supported by a relevant degree and experience in regulatory writing. Familiarity with regulatory submission formats (such as CTD), document management systems, and guidelines from agencies like the FDA or EMA is critical. Strong attention to detail, excellent written communication, and the ability to collaborate across scientific and regulatory teams are vital soft skills. These competencies ensure the accurate and compliant preparation of technical documents necessary for successful product approvals and lifecycle management.

What are some common challenges faced by CMC writers when preparing regulatory submissions?

CMC Writers often encounter challenges related to gathering and synthesizing complex scientific and technical data from cross-functional teams, such as analytical, formulation, and manufacturing experts. Keeping up with frequently changing regulatory requirements and ensuring documentation consistency across submissions can also be demanding. Effective communication and strong organizational skills are essential to manage tight deadlines and maintain high-quality, compliant documentation throughout the drug development process.

What is the difference between Cmc Writer vs Regulatory Writer?

AspectCmc WriterRegulatory Writer
CredentialsTypically requires a degree in life sciences or related field; certifications are a plusRequires similar degrees; often benefits from regulatory affairs certifications
Work EnvironmentPharmaceutical or biotech companies, focusing on chemistry, manufacturing, and control documentationRegulatory agencies or consulting firms, focusing on compliance and submission documents
Industry UsageCommonly used in biotech and pharma for CMC documentationUsed across industries for regulatory submissions and compliance

While both roles involve scientific writing, Cmc Writers focus specifically on chemistry, manufacturing, and control documentation within biotech and pharma companies. Regulatory Writers have a broader scope, handling various regulatory documents for compliance and submissions across industries. The roles often overlap but differ mainly in scope and focus area.

What cities are hiring for Cmc Writer jobs?

Cities with the most Cmc Writer job openings:

What states have the most Cmc Writer jobs?

States with the most job openings for Cmc Writer jobs include:

What are popular job titles related to Cmc Writer jobs?

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Infographic showing various Cmc Writer job openings in the United States as of September 2026, with employment types broken down into 65% Full Time, 32% Part Time, and 3% Contract. Highlights an 60% Physical, 4% Hybrid, and 36% Remote job distribution, with an average salary of $50,519 per year, or $24.3 per hour.

Associate Director, Regulatory Affairs - CMC

Plano, TX • On-site

Orano
See more jobs at Oranoexternal

Full-time

Re-posted 18 days ago

Job description

Description
Orano Med Theranostics
Orano Med has developed new processes for producing high-purity lead-212, a rare radioactive isotope. Lead-212 is currently at the heart of promising research projects in nuclear medicine to develop new treatments against cancer. The innovative approach, known as targeted alpha therapy (TAT), recognizes and destroys cancer cells while limiting the impact on nearby healthy cells.
The Associate Director, Regulatory Affairs - CMC will be responsible for leading the global regulatory CMC strategy for product development and registration, and for the preparation of CMC dossier in the expanding field of radiopharmaceuticals in the US and in EU.
This global role will join the regulatory team and will report directly to the Head of Regulatory Affairs. The person will work cross-functionally with the CMC team and the manufacturing sites to lead the regulatory CMC strategy and the preparation of regulatory CMC documentation and submissions in adherence to relevant regulatory requirements and company standards.
Key Responsibilities:
  • Leads the development and preparation of global (US and EU) CMC-related submission documents for the pipeline of radiopharmaceutical products. This includes authoring, review and consolidation to deliver high-quality documents. Working in close collaboration with the CMC team (Manufacturing, Quality, R&D process), the regulatory CMC lead will collect technical data from relevant partners to write regulatory CMC documents and support the overall project goals.
  • Develops robust global regulatory CMC strategies for the pipeline of radiopharmaceutical products. Identifies risks and proposes risk mitigation to enable successful regulatory submissions and approvals. Aligns within Regulatory Affairs to enable one regulatory voice.
  • The regulatory submissions include but are not limited to the M3/CMC section of INDs/CTAs (IMPD-Q), DMF/ASMF, briefing documents, response to queries, Orphan Drug Applications, and annual reports.
  • Manages regulatory CMC agency interactions and meetings.
  • Meets current regulatory standards and achieves timely submissions, to enable approval on the first review cycle. Effectively interprets and applies regulatory CMC guidance. Provides recommendations and solutions to cross-functional teams and key stakeholders.
  • Works with the Regulatory Operations vendor to coordinate publishing and submission for CMC dossiers (eCTD)
  • Leads or contributes to the development of internal processes to improve the regulatory and CMC ways of working.
  • Remains current on CMC regulatory intelligence.

Requirements
All candidates must meet the following minimum requirements in order to be considered for this opportunity. Candidates who exceed minimum qualifications may be considered for a higher-level position.
Minimum Qualifications:
  • Bachelor's degree in a scientific discipline. Advanced degree (MS, PharmD or PhD) is a plus.
  • A minimum of 8 years Regulatory CMC experience and/or CMC technical writing experience in a pharmaceutical or biotechnology environment including injectables.

Required Skills and Competencies:
  • Demonstrated hands-on experience in pharmaceutical development, registration in the US and/or EU, and interaction with health authorities. Demonstrated experience in preparing regulatory submissions, including IND/CTA, NDA/MAA, DMF/ASMF, briefing documents, and response to agency questions.
  • Technical knowledge in small molecules with experience in translating to a regulatory document. Knowledge of radiopharmaceuticals and innovative platforms is a plus.
  • Knowledge of relevant global CMC regulations and guidelines (ICH, US, EU)
  • Experience within a GMP environment with a firm understanding of industry regulations and best practices
  • Ability to understand and interpret complex scientific issues across multiple projects as it relates to regulatory requirements and strategy.
  • Excellent verbal and written communication skills. Able to defend the regulatory CMC position while maintaining positive professional relationships
  • Proactive, able to work independently and collaboratively in a fast-paced emerging field
  • Analytical thinker with good problem-solving skills and the capacity to adapt to a field with relatively few guidelines available.
  • Excellent planning and organization skills including the ability to support multiple projects.
  • Proficiency with Microsoft Office.
  • Travel requirements: Up to 10% travel

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