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Cmc Director Jobs (NOW HIRING)

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 ...

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 ...

Allucent

Director, CMC

Cary, NC · Remote

As a Sr. Director, CMC at Allucent, you are responsible for assisting clients with Chemistry Manufacturing and Control (CMC) and related pharmaceutical development activities of drug, biologic or ...

Revolution Medicines

Director, Global CMC Regulatory

$153K - $202K/yr

The Director, Global CMC Regulatory is a strategic leadership role responsible for developing, driving, and executing global commercial CMC regulatory strategies to secure and maintain marketing ...

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 ...

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Cmc Director information

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$43.5K

$127.5K

$239K

How much do cmc director jobs pay per year?

As of Aug 23, 2026, the average yearly pay for cmc director in the United States is $127,543.00, according to ZipRecruiter salary data. Most workers in this role earn between $88,000.00 and $150,500.00 per year, depending on experience, location, and employer.

What is a CMC director?

CMC Directors, or Chemistry, Manufacturing, and Controls Directors, are senior professionals responsible for overseeing the development, production, and quality assurance of pharmaceutical products. They manage the CMC aspects of drug development, ensuring that products meet regulatory requirements and quality standards from research through commercialization. CMC Directors lead cross-functional teams, coordinate with regulatory agencies, and play a crucial role in ensuring that manufacturing processes are efficient, compliant, and scalable. Their expertise helps bring safe and effective medications to market while adhering to regulatory timelines and budgets.

What are the main challenges a CMC director faces when coordinating between regulatory, manufacturing, and R&D teams?

A CMC Director often navigates complex challenges in aligning the priorities and timelines of regulatory, manufacturing, and R&D teams. Balancing the need for regulatory compliance with the fast-paced demands of product development requires strong communication and project management skills. Additionally, adapting to evolving global regulatory standards while ensuring manufacturing processes remain efficient and scalable is a key part of the role. Close collaboration and proactive problem-solving are essential to ensure products move smoothly from development to commercialization.

What are the key skills and qualifications needed to thrive as a CMC director, and why are they important?

To thrive as a CMC (Chemistry, Manufacturing, and Controls) Director, you need deep expertise in pharmaceutical development, regulatory requirements, and quality assurance, typically supported by an advanced degree in chemistry, pharmacy, or a related field. Familiarity with regulatory submission systems (e.g., eCTD), quality management systems (QMS), and relevant certifications such as PMP or Six Sigma is often required. Strong leadership, project management, and cross-functional communication skills set successful CMC Directors apart. These competencies ensure the efficient development and compliance of pharmaceutical products from concept through commercialization, meeting regulatory standards and business goals.

What is the difference between Cmc Director vs Cmc Manager?

AspectCmc DirectorCmc Manager
ResponsibilitiesOversees entire CMC development, strategic planning, and regulatory complianceManages daily operations, coordinates teams, and executes CMC activities
Required CredentialsAdvanced degree (PhD, MSc), extensive industry experience, regulatory knowledgeBachelor's or Master's degree, relevant industry experience
Work EnvironmentStrategic, leadership-focused, often in corporate officesOperational, team management, hands-on in labs or manufacturing

The Cmc Director typically holds a higher strategic role, focusing on overall development and compliance, while the Cmc Manager handles daily operations and team coordination. Both roles require relevant industry experience, but the director's responsibilities are broader and more strategic.

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Cmc Director jobs near you
Infographic showing various Cmc Director job openings in the United States as of August 2026, with employment types broken down into 2% As Needed, 83% Full Time, 12% Part Time, 1% Temporary, and 2% Contract. Highlights an 91% Physical, 3% Hybrid, and 6% Remote job distribution, with an average salary of $127,543 per year, or $61.3 per hour.

Director, Regulatory CMC

Genetix Biotherapeutics

Somerville, MA • Hybrid

$163K - $216K/yr

Full-time

Re-posted 8 days ago

Job description

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

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