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Cmc Director Jobs (NOW HIRING)

Director, CMC Quality Position Summary BrainChild Bio is seeking an experienced Director, CMC Quality to provide strategic quality leadership across the development and lifecycle management of its ...

Director, CMC Quality

$190K - $210K/yr

Director, CMC Quality Position Summary BrainChild Bio is seeking an experienced Director, CMC Quality to provide strategic quality leadership across the development and lifecycle management of its ...

$166K - $220K/yr

Join our dynamic and expanding mid-size company in the role of Director for Regulatory CMC directly reporting to Executive Director, Regulatory CMC. Your expertise will play a pivotal and visible ...

Director, Regulatory Affairs CMC

Pleasanton, CA · Hybrid

$166K - $220K/yr

Join our dynamic and expanding mid-size company in the role of Director for Regulatory CMC directly reporting to Executive Director, Regulatory CMC. Your expertise will play a pivotal and visible ...

Role The Associate Director/Director/Sr. Director, Regulatory CMC reports to the Vice President of ... This Regulatory CMC leader is accountable for developing and executing global CMC regulatory ...

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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 Sep 13, 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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Infographic showing various Cmc Director job openings in the United States as of September 2026, with employment types broken down into 2% As Needed, 85% Full Time, 12% Part Time, and 1% Contract. Highlights an 89% Physical, 3% Hybrid, and 8% Remote job distribution, with an average salary of $127,543 per year, or $61.3 per hour.

Director, Regulatory Affairs CMC

San Diego, CA • On-site

Scorpion Therapeutics
51 - 200 employees

$189K - $237K/yr

Other

Medical, Dental, Vision, Life, Retirement, PTO

Posted 14 days ago


Job description

Position Summary

Director, Regulatory CMC. Hybrid role (office ~3 days/week) in San Diego, CA; San Francisco, CA; or Princeton, NJ.

Primary Responsibilities
  • Manage CMC regulatory affairs for marketed products and compounds in development (US and ex-US).
  • Coordinate with R&D, Pharmaceutical Development, Manufacturing, Quality, and other functions to develop/implement CMC regulatory strategy.
  • Lead timely preparation of CMC sections of INDs, CTAs, NDAs, MAAs, and amendments for global submissions.
  • Serve as regulatory CMC expert and point of contact for agencies on CMC development, registration, and lifecycle activities.
  • Provide CMC guidance/risk identification and mitigation for development teams.
  • Ensure CMC compliance with applicable regulations/guidelines.
  • Evaluate manufacturing processes/changes; assess regulatory implications; support implementation.
  • Maintain knowledge of relevant regulations and determine applicability.
Education/Experience/Skills
  • BS in life science (or related); equivalent education/experience considered.
  • ~10 years progressively responsible CMC Regulatory Affairs (small molecules), including 5 years in management.
  • Knowledge of global regulatory CMC requirements.
  • Experience preparing/submitting CMC components of IND/CTA, briefing packages, NDA, and ex-US MAA.
  • Cross-functional collaboration; strong organization; detail-oriented; deadline management.
  • Negotiation/influencing skills; initiative; ability to work with limited supervision.
  • Willingness to travel domestically/internationally.
Compensation/Benefits
  • Discretionary bonus and equity awards.
  • Salary range: $189,700–$237,100.
  • Medical/dental/vision; life/disability/travel/EAP; 401(k) match (1:1 up to 5%); ESPP; 15+ vacation; 13–15 paid holidays; 10 paid sick days; paid parental leave; tuition assistance.
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