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Cmc Writing Jobs (NOW HIRING)

Altimmune

CMC Director, Regulatory Affairs

Morristown, NJ

$154K - $204K/yr

Manages all aspects of regulatory CMC activities, assists in the development of regulatory ... Excellent oral and written communication skills. Altimmune provides equal employment opportunities ...

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 ...

CSL

GRA CMC Specialist

King Of Prussia, PA

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 ...

Codera

Director, CMC - Formulations

San Diego, CA · Remote

$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 ...

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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.

Senior Director, Regulatory CMC

Senti Biosciences

South San Francisco, CA • On-site

$245K - $285K/yr

Full-time

Posted 26 days ago

Job description

The successful candidate will be responsible for leading and managing the regulatory affairs within CMC function. This includes developing and leading regulatory CMC strategies and activities for a complex cell therapy product on a global basis. The successful candidate will ensure that all CMC regulatory goals are clearly defined and they align with current industry standards and regulatory requirements. This role will also provide significant input on applicable regulatory affairs processes, procedures, and tools to facilitate effective execution by the regulatory function across the organization. This individual must be highly skilled and provide expertise in CMC agency interactions and developing regional regulatory CMC strategies. In addition, the position assists corporate senior management in understanding CMC Regulatory strategies/processes while developing corporate objectives and, importantly, understanding the impact of decisions across therapeutic areas. Familiarity with GMP Quality, CMC development and exposure to clinical regulatory strategy is highly desired. (***For the potential candidate at VP level direct report possibilities)
Responsibilities
  • Develop the CMC regulatory strategies and manage related regulatory activities. Work with the Pharmaceutical Development team to prepare project plans and timelines for pipeline of products, including coordination and oversight of all types of regulatory CMC submissions including type B, C, D meetings.
  • Supervises/manages others to ensure that all reporting requirements and other commitments are met with respect to INDs, BLAs, CTA, MAAs, etc. Prep and author updates in conjunctions with the cross-functional teams.
  • Advise the global regulatory phase-appropriate compliance of gene and cell therapy pipeline of products including the evaluation of CMC related change controls, the strategic assessment of process and product comparability, their regulatory impact and implementation.
  • Lead the preparation, authoring, review and filing of CMC sections of regulatory submissions with the highest quality and robust interactions with regulatory agencies.
  • Maintain a centralized archive for tracking and monitoring the status of regulatory CMC commitments and agency reporting obligations. Create and issue status reports and other communication to the organization.
  • Provide strategic CMC regulatory support, guidance and expertise, and act as the Regulatory Affairs primary point of contact to cross-functional teams including Pharmaceutical Development, Quality Assurance, Quality Control, contract organizations and consultants. Ensure that all applicable regulatory requirements/options and associated risks are considered and appropriately incorporated into development programs and that products are developed and manufactured in compliance with appropriate regulations and guidelines.
  • Work across functional groups in identifying issues that may delay timelines, providing solutions to difficult technical/functional issues associated with specific projects, as well as support the resolution of issues that arise.
  • Ensure the regulatory conformance of technical documentation including technical transfer protocols, validation protocols, technical reports, manufacturing and labeling information.
  • Provide guidance and advice on regulatory CMC environments and trends; provide assessment of the impact of new and changing regulations/requirements.
  • Author, review, and maintain regulatory and scientific documents to support business and submission needs.
  • Track and report on Medical Writing and Regulatory Operations projects, timelines, and key milestones to support timely execution.

Qualifications
  • BA/BS in a scientific field of study with 10 years + of relevant experience working in Regulatory in the pharmaceutical/ biotech industry.
  • Strong knowledge, experience and leadership in interpretation of regulations and guidelines related to biologics drug development.
  • Experience in the gene or cell therapy area is preferred.
  • Proven ability to analyze and organize information logically.
  • In depth understanding and application of industry standards and international regulations and guidelines.
  • Experience in communicating regulatory strategy, submission documents and plans both internally and externally.
  • The ability to coordinate and prioritize multiple projects in a fast-paced, deadline driven start-up environment.
  • Strong collaboration, team work, organizational skills at attention to detail
  • Excellent written and verbal communication skills.
  • Travel 20%

Salary and Benefits
  • Compensation for this role includes base salary, annual target bonus and equity
  • The base salary range for this role is $245,000-285,000. Starting pay is determined by multiple job-related factors including a candidate's skills, education and experience level, benchmark, and internal parity
  • Significant growth opportunity as the company expands
  • Empathetic, supportive and collaborative colleagues and work environments

We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.

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