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Cmc Director Jobs (NOW HIRING)

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Director, Regulatory Affairs - CMC

Blue Bell, PA · Remote

$143.30K - $189.20K/yr

Director, Regulatory Affairs - CMC ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster. As a ...

Vaxcyte

Associate Director, Regulatory CMC

San Carlos, CA · On-site

$180K - $210.50K/yr

Executive Director, CMC Regulatory Location: San Carlos, CA / US Remote Work Arrangement: Remote Compensation: The compensation package will be competitive and includes comprehensive benefits and an ...

ICON

Director, Regulatory Affairs - CMC

Blue Bell, PA · On-site

$143.30K - $189.20K/yr

Director, Regulatory Affairs - CMC ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and ...

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$127.5K

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How much do cmc director jobs pay per year?

As of May 29, 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 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 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 CMC Directors?

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 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.

More about Cmc Director jobs
What cities are hiring for Cmc Director jobs? Cities with the most Cmc Director 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 Director jobs? States with the most job openings for Cmc Director jobs include:
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Cmc Director jobs near you
Infographic showing various Cmc Director job openings in the United States as of May 2026, with employment types broken down into 4% Full Time, 81% Part Time, 6% Temporary, 8% Contract, and 1% Summer. Highlights an 95% Physical, and 5% Remote job distribution, with an average salary of $127,543 per year, or $61.3 per hour.

Director Regulatory Affairs (CMC)

Lynkx Staffing LLC

Princeton, NJ

$158.60K - $209.40K/yr

Full-time

Posted 17 days ago

Job description

Our Pharmaceutical client is seeking a Director Regulatory Affairs Chemistry Manufacturing & Controls (CMC) to guide global teams through the development and execution of regulatory strategy and the design of CMC components of drug development programs in collaboration with counterparts, investigators, project team members, and consultants.
  • Plan, prepare, and critically review CMC components of regulatory documents including INDs, Annual Reports/DSURs, Amendments, Comparability Protocols and Evaluation Packages, BLAs, NDAs, DMFs, Meeting Briefing Packages, SPA, IBs, and equivalent documents of other countries’ health authorities without supervision. Respond in a timely manner to deficiency questions and inquiries from health authorities. Collaborate with project team representatives to ensure those documents meet regulatory requirements/guidance, and ensure clear communication of risks to the executive management.
  • Lead all RA-CMC operations through all phases of clinical development; from FIH through post-approval maintenance.
  • Communicate and collaborate with global counterparts effectively, ensuring alignment.
  • Mentor lower-level members in RA and RA-CMC in lifecycle regulatory-CMC and eCTD strategy.
  • Lead and/or participate in process improvement initiatives between business entities.
  • Lead the CMC aspects of Health Authority meetings.
  • Responsible as a back up to the Head of Regulatory CMC.
REQUIREMENTS
  • MS Degree required with 15+ years of related experience in the pharmaceutical or biopharmaceutical industry
  • Up-to-date knowledge of both existing and emerging regulatory guidance and sciences related to CMC.
  • Good working knowledge of Microsoft Office required.
  • Prior experience with authoring, submission, and approval process of a major marketing application
  • Prior experience with assessing change controls and the preparation of post-approval supplements
  • Experience with primary authoring of all drug substance and drug product sections
  • Cultural sensitivity is essential and the ability to develop consensus within a multinational organization necessary.
  • Broad level of interpersonal skills, leadership ability and flexibility also necessary.
  • Excellent collaboration skills needed.
  • Excellent problem-solving skills also needed.
Lynkx Staffing LLC specializes in placing professionals in the Pharmaceutical and Medical Device industries in New Jersey.