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Cmc Writing Jobs (NOW HIRING)

Initial Therapeutics, Inc.

Director, RA CMC

California, MO · On-site

$130 - $170/hr

Prepares CMC regulatory strategies that enable first pass approvals. Develops and manages content ... Strong oral and written communication skills. Additional Information * The compensation range ...

Codera LLC

Director, CMC - Formulations

San Diego, CA · On-site

$190K - $260K/yr

Position Summary The Director, CMC - Formulations will contribute to the oversight, planning and ... Experience writing and/or reviewing regulatory documents, including Investigational New Drug (IND ...

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 ...

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Cmc Writing information

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How much do cmc writing jobs pay per hour?

As of Aug 22, 2026, the average hourly pay for cmc writing in the United States is $30.96, according to ZipRecruiter salary data. Most workers in this role earn between $19.47 and $37.26 per hour, depending on experience, location, and employer.

What is the difference between Cmc Writing vs Medical Writing?

AspectCmc WritingMedical Writing
Required CredentialsBachelor's degree in life sciences, chemistry, or related field; often certifications in pharmaceutical writingDegree in life sciences, healthcare, or related; certifications like AMWA or DIA often preferred
Work EnvironmentPharmaceutical companies, biotech firms, contract research organizations (CROs)Pharmaceutical companies, medical communication agencies, CROs
Industry UsageFocuses on Chemistry, Manufacturing, and Controls documentation for drug approvalEncompasses clinical study reports, regulatory documents, and scientific publications

In summary, Cmc Writing specializes in regulatory documentation related to drug manufacturing and chemistry, while Medical Writing covers a broader range of clinical and scientific communication. Both roles require similar credentials and often work within the pharmaceutical industry, but they focus on different aspects of drug development and documentation.

What are typical Cmc Writing job responsibilities?

Cmc Writing jobs typically involve creating, editing, and reviewing scientific or technical documentation related to chemistry, manufacturing, and control processes. Responsibilities include ensuring compliance with regulatory standards, preparing detailed reports, and collaborating with cross-functional teams. Strong writing skills, knowledge of industry regulations, and attention to detail are essential for this role.

What is a Cmc Writing?

Cmc Writing typically refers to writing related to Chemistry, Manufacturing, and Controls (CMC) in the pharmaceutical industry, involving documentation for drug development and regulatory submissions. It requires strong technical writing skills, attention to detail, and knowledge of regulatory standards. Professionals in this field often work with scientific data, validation protocols, and compliance documentation.

What cities are hiring for Cmc Writing jobs?

Cities with the most Cmc Writing job openings:

What states have the most Cmc Writing jobs?

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

What job categories do people searching Cmc Writing jobs look for?

The top searched job categories for Cmc Writing jobs are:

Cmc Writing jobs near you
Infographic showing various Cmc Writing job openings in the United States as of August 2026, with employment types broken down into 90% Full Time, and 10% Contract. Highlights an 100% In-person job distribution, with an average salary of $64,401 per year, or $31 per hour.

Associate Manager CMC Regulatory Compliance

The businesses of Merck KGaA, Darmstadt, Germany

Billerica, MA • On-site

$77K - $116K/yr

Full-time

Medical, Retirement, PTO

Re-posted 6 days ago

Job description

Work Your Magic with us!Start your next chapter and join MilliporeSigma.

Ready to explore, break barriers, and discover more? We know you've got big plans - so do we! Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.

This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US.


Your Role:

As the Associate Manager Regulatory CMC (RCMC), you are responsible for supporting all CMC regulatory activities including development, authoring and ownership of the CMC dossier Strategy Document, as well as all CMC Dossier types, their content and decision making on content, for assigned submissions worldwide, and serve as the liaison with the Global Healthcare Operations and R&D functions, being the contact person for all Regulatory CMC topics.

Location:Hybrid (3x/week) in Billerica, MA office

Key Accountabilities:

Global Product Oversight:

  • Ensures global product oversight for the Regulatory CMC part of their product(s) / project(s)

Regulatory CMC strategy and Health Authority interactions:

  • Supports the development and definition of the Global Regulatory CMC strategy for development programs (pre-clinical to commercial application). Leads and drives global regulatory CMC strategy for the assigned projects/products in target regions/countries. This encompasses responsibility for the Regulatory CMC topics, risk assessment & mitigation, regulatory CMC strategic support and advice to interdisciplinary internal teams
  • Supports the preparation of HA meetings and Health Authority interactions on CMC topics

Management of CMC Regulatory Activities; CMC Dossier generation:

  • Responsible and accountable for driving all regulatory CMC activities for assigned projects/products.
  • Responsible for CMC Dossier types such as IMPD/IND, Health Authority Meeting Packages (incl. meeting request), variations, amendments, Module 1 CMC regulatory binding documents, Annual reports, CMC information in the Investigators Brochure, and Health Authority questions up to approval.
  • Provides the Global Regulatory CMC advice & expertise in cross-functional project teams.
  • Acts as liaison between Global Health Operations and R&D functions as single point of contact for all CMC topics.
  • Supports the development and provision of country specific regulatory CMC requirements for CMC dossier strategies and plans.

Regulatory intelligence and knowledge management:

  • Reviews draft and newly released laws and guidance on behalf of the Company. Leading and participation in internal as well as cross-functional, international initiatives.

Global Regulatory Affairs CMC coordination:

  • Supports development and execute initiatives
  • Plans regulatory CMC activities and develops submission roll-out plans, in close collaboration with key stakeholders

Who You Are:

Minimum Qualifications:

  • Bachelor's Degree in a Life Science discipline
  • 1+ years of pharmaceutical industry or academia experience and regulatory or CMC knowledge

Preferred Qualifications:

  • Master's Degree or PhD
  • Strong written and verbal skills
  • Ability to develop and prepare successful regulatory CMC strategies and CMC dossiers
  • Experience in preparation of regulatory CMC documentation
  • Experience with life-cycle management activities in EU, USA and International
  • Practical experience in one of the following areas: manufacturing process development, transfers, validation or analytical development and control strategies

Pay Range for this position - $77,800 - $116,700

The offer range represents the anticipated low and high end of the base pay compensation for this position. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. Position may be eligible for sales or performance-based bonuses. Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other perquisites. For more information click here.

RSREMD


What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!

Apply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity!

Employment Type: FULL_TIME

Apply