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Cmc Jobs (NOW HIRING)

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 ...

CSL

GRA CMC Specialist

King Of Prussia, PA · On-site

Ensuring operational alignment of Global Regulatory Affairs CMC activities and processes with R&D Global Regulatory Affairs and within Global Operations business needs. This role promotes strong ...

CSL

GRA CMC Specialist

King Of Prussia, PA · On-site

Ensuring operational alignment of Global Regulatory Affairs CMC activities and processes with R&D Global Regulatory Affairs and within Global Operations business needs. This role promotes strong ...

BrainChild Bio

Director, Regulatory Affairs, CMC

$153K - $202K/yr

BrainChild Bio is seeking a Director, Regulatory Affairs, CMC , to support implementation of the global regulatory CMC strategy across our clinical-stage cell therapy programs. BrainChild Bio is a ...

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 ...

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 ...

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 ...

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 ...

CSL

GRA CMC Specialist

King Of Prussia, PA

Ensuring operational alignment of Global Regulatory Affairs CMC activities and processes with R&D Global Regulatory Affairs and within Global Operations business needs. This role promotes strong ...

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CMC information

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$13

$31

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How much do cmc jobs pay per hour?

As of Aug 6, 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 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 is a CMC?

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.

More about CMC jobs
What cities are hiring for Cmc jobs? Cities with the most Cmc job openings:
What are the most commonly searched types of Cmc jobs? The most popular types of Cmc jobs are:
What states have the most Cmc jobs? States with the most job openings for Cmc jobs include:
What job categories do people searching Cmc jobs look for? The top searched job categories for Cmc jobs are:
CMC jobs near you
Infographic showing various Cmc job openings in the United States as of August 2026, with employment types broken down into 1% As Needed, 75% Full Time, 21% Part Time, and 3% Contract. Highlights an 93% Physical, 2% Hybrid, and 5% Remote job distribution, with an average salary of $64,986 per year, or $31.2 per hour.

Director, Regulatory CMC

Genetix Biotherapeutics

Somerville, MA • On-site

$163K - $216K/yr

Full-time

Medical, Life, Retirement

Re-posted 21 days ago

Job description

About Genetix Biotherapeutics
At Genetix Biotherapeutics every role has meaning, every team member is respected, and every day is a chance to make a difference. When you join Genetix, you're not just landing a new role, you become part of a company that's pursuing curative gene therapies to give patients and their families more days. We are doers, thinkers and collaborators who embrace and live by our values:
Our innovation is rooted in the diversity of our teams and results are achieved through cooperation and the integration of multiple viewpoints. This is personal and we approach every challenge with radical care.
The Director, Regulatory CMC is responsible for leading execution of global CMC regulatory strategies for approved and late-stage gene therapy products, with a primary focus on lifecycle management, change management, and regulatory compliance. This role supports the development and delivery of post-approval regulatory strategies and ensures effective implementation of manufacturing, analytical, and control changes across global markets.
The Director partners closely with Technical Operations, Quality, and Supply Chain to ensure alignment between regulatory requirements and operational execution. This individual contributes to regulatory interactions with health authorities and plays a key role in supporting post-approval submissions, inspection readiness, and ongoing compliance activities.
This is a full-time hybrid position (3 days a week) in our Somerville, Massachusetts office.
Specific Job Duties
  • Lead execution of post-approval CMC lifecycle management activities, including preparation and submission of global supplements, variations, and annual reports
  • Support development and implementation of CMC change management strategies, assessing manufacturing, analytical, raw material, facility, and control changes and recommending appropriate regulatory pathways
  • Manage regulatory CMC activities supporting commercial manufacturing, supply continuity, and inspection readiness, including drafting responses to health authority questions and commitments
  • Contribute to regulatory interactions with global health authorities (e.g., FDA, EMA), including support for meetings, information requests, and inspection activities
  • Partner with Technical Operations, Quality, Supply Chain, and Program Teams to ensure regulatory strategy aligns with operational plans and timelines
  • Author and review post-approval CMC documentation, ensuring consistency with approved dossiers and global regulatory requirements
  • Ensure adherence to global CMC regulatory standards and guidance (FDA, EMA, ICH) applicable to commercial and post-approval gene therapy products
  • Monitor and apply regulatory intelligence related to post-approval expectations, emerging guidance, and inspection trends
  • Provide mentorship and guidance to junior Regulatory CMC team members as appropriate
  • Represent Regulatory CMC on cross-functional teams and provide clear, risk-based regulatory input to support decision-making
Required Education, Experience, or Qualifications
  • Bachelor's or Master's degree in life sciences (biochemistry, chemistry, biology, biochemical engineering, or related field)
  • Minimum of 10-12 years of biopharmaceutical industry experience, with relevant experience in CMC regulatory affairs for biologics or gene therapy products
  • Experience supporting post-approval CMC submissions (e.g., supplements, variations, annual reports) and regulatory interactions
  • Strong understanding of commercial manufacturing and lifecycle management for complex biologics and/or gene therapy products
  • Solid knowledge of GMP, CMC regulatory requirements, and global regulatory frameworks (FDA, EMA, ICH)
  • Strong written and verbal communication skills, with the ability to translate technical information into clear regulatory documentation
  • Demonstrated ability to work effectively in cross-functional, matrixed environments
  • Strong organizational skills and ability to manage multiple priorities in a fast-paced environment

Additional Information
The pay transparency range provided below is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. We may ultimately pay more or less than the posted range, and the range may be modified in the future. This role is eligible for an annual bonus and long-term incentive. Actual base salary pay will be based on several factors, including but not limited to experience, skills, relevant education/qualifications, external market, internal equity, and other job-related factors permitted by law.
Genetix's total rewards package also provides employees with a comprehensive and competitive benefits suite to support a variety of employee needs. These benefits include comprehensive health, life and disability insurance, employer-matched 401(k) plan, lifestyle spending account, flexible time-off + paid holidays and winter holiday period, tuition reimbursement & loan repayment assistance, paid parental leave, paid onsite parking, commuter subsidy, and much more.
Pay Transparency
$204,000-$245,000 USD
Genetix is proud to be an equal opportunity employer, seeking to create a welcoming and diverse environment. All applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status or any other applicable legally protected characteristics.

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