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Cmc Jobs (NOW HIRING)

Altimmune

CMC Director, Regulatory Affairs

Morristown, NJ · On-site

$154K - $204K/yr

Responsible for high-quality CMC regulatory submissions in support of approval of global marketing and clinical trial applications * Manages all aspects of regulatory CMC activities, assists in the ...

Altimmune

CMC Director, Regulatory Affairs

Morristown, NJ · Remote

$153K - $202K/yr

Responsible for high-quality CMC regulatory submissions in support of approval of global marketing and clinical trial applications * Manages all aspects of regulatory CMC activities, assists in the ...

Altimmune

CMC Director, Regulatory Affairs

Morristown, NJ

$154K - $204K/yr

Responsible for high-quality CMC regulatory submissions in support of approval of global marketing and clinical trial applications * Manages all aspects of regulatory CMC activities, assists in the ...

AbbVie

Director, RA CMC

North Chicago, IL · On-site

$160K/yr

Prepares CMC regulatory strategies that enable first pass approvals. Develops and manages content strategy for regulatory submissions, including INDs/CTAs and amendments, new marketing applications ...

AbbVie

Director, RA CMC

North Chicago, IL · On-site

$144K - $190K/yr

Prepares CMC regulatory strategies that enable first pass approvals. Develops and manages content strategy for regulatory submissions, including INDs/CTAs and amendments, new marketing applications ...

AbbVie

Director, RA CMC

North Chicago, IL · On-site

$144K - $190K/yr

Prepares CMC regulatory strategies that enable first pass approvals. Develops and manages content strategy for regulatory submissions, including INDs/CTAs and amendments, new marketing applications ...

Vaxcyte

Associate Director, Regulatory CMC

San Carlos, CA · On-site +1

$180K - $210K/yr

Provides regulatory CMC guidance to various cross-functional teams and ensures all applicable global regulatory requirements are considered and incorporated into product development. Conducts routine ...

Calico

Director, Regulatory CMC

South San Francisco, CA · On-site

$275K - $280K/yr

The Director of Regulatory CMC will lead the development and execution of global CMC regulatory strategies for our pipeline of small molecules and monoclonal antibodies to accelerate clinical ...

AbbVie

Director, RA CMC

Irvine, CA · On-site

$161K - $212K/yr

Prepares CMC regulatory strategies that enable first pass approvals. Develops and manages content strategy for regulatory submissions, including INDs/CTAs and amendments, new marketing applications ...

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Cmc information

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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.

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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 Director, Regulatory Affairs

CMC Director, Regulatory Affairs

Altimmune

Morristown, NJ • On-site

$154K - $204K/yr

Full-time

Posted 27 days ago

Job description

Altimmune (NASDAQ: ALT) is a clinical stage biopharmaceutical company focused on developing treatments for obesity and liver diseases. Our pipeline includes next generation peptide therapeutics for treatment of obesity, metabolic dysfunction-associated steatohepatitis (MASH), alcohol-associated liver disease (ALD), and alcohol use disorder (AUD). For more information, please visit .
Job Description: This individual will be responsible for providing global regulatory CMC support throughout the product lifecycle (e.g., regulatory strategies, preparing CMC filings and submissions to regulatory applications, regulatory submission timeline development, and regulatory intelligence). This position reports to the Head of Regulatory Affairs.
Essential Functions:
  • Responsible for high-quality CMC regulatory submissions in support of approval of global marketing and clinical trial applications
  • Manages all aspects of regulatory CMC activities, assists in the development of regulatory submission timelines, and ensures execution to meet corporate goals
  • Responsible for the preparation of all CMC sections/information filed in support of global clinical trial and marketing applications; ensures all CMC regulatory filings are prepared accurately and completed in a timely manner
  • Manages global CMC regulatory projects as assigned and assists in the development of relevant timelines and ensures execution to meet corporate goals
  • Performs regulatory assessments of CMC changes, identifying global regulatory filing requirements
  • Responsible for submission of supporting amendments and updates to relevant applications for CMC-related changes
  • Manages the preparation and submission of formal CMC-related regulatory meeting requests and briefing packages and coordinates meetings with regulatory agencies
  • Leads CMC-related FDA meetings and interfaces with regulatory/competent authorities, negotiating resolution of regulatory issues affecting Altimmune's development programs
  • Interprets FDA regulations/guidelines governing drugs, devices, and biologics and advises Senior Management on pertinent regulatory intelligence
  • Represents and participates in project/program teams and sub-teams, as required
  • Participates in the development, review, and implementation of departmental SOPs and processes.

Job Requirements (Essential knowledge, skills and attributes):
  • S/Ph.D. degree in chemistry, pharmaceutical science, engineering or related discipline is preferred with a minimum of 5-10 years regulatory CMC or CMC-related experience in the biotech/pharma industry
  • Experience in CMC regulatory lifecycle management, including compiling, reviewing, and managing CMC modules of eCTD submissions
  • Operational experience in regulatory submissions management, compiling and managing eCTD submissions, and formal correspondence and liaison with regulatory agencies
  • Ability to interpret FDA Regulations, EU Directives, and global regulatory guidelines governing CMC filing requirements for approval of marketing and clinical trial applications for drugs and biological products
  • Excellent planning, organization, and project management skills, including the ability to adjust to rapidly changing priorities and manage multiple projects simultaneously
  • Experience and knowledge in the preparation of global regulatory submissions (e.g., original IND/IND amendments, CTAs)
  • Must be self-motivated with a positive attitude and ability to work well with others
  • Excellent oral and written communication skills.

Altimmune provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

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