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Cmc Director Jobs (NOW HIRING)

Allucent

Sr. Director, CMC

Cary, NC · On-site +1

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 ...

Allucent

Sr. 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 ...

Vaxcyte

Associate Director, Regulatory CMC

San Carlos, CA · On-site

$180K - $210K/yr

Executive Director, CMC Regulatory Location: US Remote Work Arrangement (may be adjusted based on business needs, job responsibilities, or changes to company policy): Remote Compensation: The ...

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$239K

How much do cmc director jobs pay per year?

As of Jul 14, 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 the highest paying job in regulatory affairs?

The highest paying roles in regulatory affairs are typically senior executive positions such as Vice President or Director of Regulatory Affairs, with salaries often exceeding $150,000 annually. These roles require extensive experience, leadership skills, and knowledge of industry regulations, often supported by advanced certifications like RAC (Regulatory Affairs Certification).

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 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 does a CMC leader do?

A CMC (Chemistry, Manufacturing, and Controls) leader oversees the development, manufacturing, and regulatory compliance of pharmaceutical products. They coordinate cross-functional teams, ensure adherence to quality standards, and prepare documentation for regulatory submissions. Strong knowledge of GMP regulations and project management skills are essential in this role.

What does a CMC specialist do?

A CMC (Chemistry, Manufacturing, and Controls) specialist is responsible for developing, overseeing, and ensuring compliance of manufacturing processes and documentation for pharmaceutical products. They work closely with regulatory agencies, prepare technical reports, and ensure products meet quality standards throughout development and production. Strong knowledge of GMP regulations and experience with regulatory submissions are essential skills for this role.

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 a CMC manager?

A CMC manager, or Chemistry, Manufacturing, and Controls manager, oversees the development, manufacturing, and regulatory compliance of pharmaceutical products. They coordinate activities related to quality assurance, documentation, and process validation to ensure products meet industry standards and regulatory requirements. Strong knowledge of GMP guidelines and regulatory submissions is essential for this role.

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
Associate Director, CMC Regulatory

Associate Director, CMC Regulatory

Revolution Medicines

Redwood City, CA • On-site

Full-time

Posted 26 days ago

Job description

Revolution Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers. The company's R&D pipeline comprises RAS(ON) inhibitors designed to suppress diverse oncogenic variants of RAS proteins. The company's RAS(ON) inhibitors daraxonrasib (RMC-6236), a RAS(ON) multi-selective inhibitor; elironrasib (RMC-6291), a RAS(ON) G12C-selective inhibitor; zoldonrasib (RMC-9805), a RAS(ON) G12D-selective inhibitor; and RMC-5127, a RAS(ON) G12V-selective inhibitor, are currently in clinical development. As a new member of the Revolution Medicines team, you will join other outstanding professionals in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway.
The Opportunity:
As part of our expanding organization, we seek a strategic and hands-on Associate Director, CMC Regulatory who will be responsible for executing CMC regulatory strategies to support clinical development, marketing authorizations, and lifecycle management of RevMed's pipeline compounds/products.
This role involves coordinating and preparing CMC sections of regulatory submissions to support RevMed's global clinical trials, including programs executed in collaboration with external partners, marketing applications, and post approval changes. The ideal candidate should have a strong understanding of global regulatory requirements and be able to guide CMC teams throughout the drug development process.
Primary Responsibilities:
  • Develop, lead, and implement global CMC regulatory strategies to support clinical development through registration and post-marketing activities.
  • Provide CMC regulatory leadership for global clinical trial execution, including RevMed-sponsored trials and incoming/outgoing external collaborations, ensuring appropriate CMC strategy, documentation, cross-referencing, and health authority compliance across sponsors, regions, and development stages.
  • Lead the preparation and maintenance of the CMC / quality sections for regulatory submissions including initial submission of IND, IMPD/CTA, NDA, MAA and amendments to Health Authorities (HAs), and preparation of responses to queries from HAs.
  • Serve as the CMC regulatory representative on project teams and provide CMC regulatory support for the clinical development of the investigational product(s) and ensure applicable regulatory requirements are appropriately met.
  • Collaborate with corporate regulatory team, CMC SMEs and/or CROs to identify. regional/country-specific CMC requirements to support global applications, and to drive the CMC submission timelines in order to meet business objectives.
  • Provide regulatory assessment and guidance on CMC related change controls, deviations, and investigations throughout product life cycle.
  • Lead and/or contribute to internal process improvements, SOP development, and organizational initiatives to support globalization of RevMed's products.
  • Maintain knowledge of global competitive landscape, regulatory environment, regulations and CMC guidance, providing interpretation to internal stakeholders.

Required Skills, Experience and Education:
  • BA/BS degree in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or related scientific discipline.
  • Minimum of 10 years of experience in pharmaceutical/biotech drug development, including at least 5 years in global CMC regulatory affairs.
  • Experience in leading CMC related global clinical and commercial submissions (IND, IMPD/CTA, NDA, MAA, etc.) (US, EU, APAC, LATAM).
  • Solid knowledge of US and international GMP quality regulations, current industry practices, and experience with interpretation and application to development projects and marketed product regulatory issues.
  • Demonstrated experience in effective collaboration with internal and external stakeholders.
  • Ability to prioritize and manage multiple projects simultaneously in a dynamic company environment
  • Experience with small molecules (NCEs) and managing complex CMC technical documentation.
  • Excellent communication and stakeholder management skills, including experience working cross-functionally and with external partners.
  • Ability to operate effectively in a fast-paced, matrixed, global environment.

Preferred Skills:
  • An advanced degree (PhD, PharmD, MSc) in Pharmaceutical Science, Chemistry, Chemical Engineering or related field is desirable. #LI-Hybrid #LI-CT1

The base pay salary range for this full-time position for candidates working onsite at our headquarters in Redwood City, CA is listed below. The range displayed on each job posting is intended to be the base pay salary range for an individual working onsite in Redwood City and will be adjusted for the local market a candidate is based in. Our base pay salary ranges are determined by role, level, and location. Individual base pay salary is determined by multiple factors, including job-related skills, experience, market dynamics, and relevant education or training.
Please note that base pay salary range is one part of the overall total rewards program at RevMed, which includes competitive cash compensation, robust equity awards, strong benefits, and significant learning and development opportunities.
Revolution Medicines is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital status, medical condition, and veteran status.
Revolution Medicines takes protection and security of personal data very seriously and respects your right to privacy while using our website and when contacting us by email or phone. We will only collect, process and use any personal data that you provide to us in accordance with our CCPA Notice and Privacy Policy. For additional information, please contact privacy@revmed.com.
Base Pay Salary Range
$186,000-$233,000 USD
We are aware of recent recruitment scams in which individuals or organizations falsely represent themselves as being affiliated with Revolution Medicines. These scams may appear as false job advertisements or unsolicited contacts through communication or chat platforms, email, phone, or text message.
Please note that Revolution Medicines does not extend unsolicited employment offers and will never ask candidates to provide financial information, purchase equipment, or pay fees as part of the hiring process. All legitimate communication from Revolution Medicines will come from an official @revmed.com email address.
If you believe you've been contacted by someone impersonating a Revolution Medicines recruiter, please report it to careers@revmed.com so we can share these impersonations with our IT team for tracking and awareness.

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