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Cmc Regulatory Jobs (NOW HIRING)

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 ...

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 ...

Legend Biotech US

Manager, Regulatory CMC

Somerset, NJ · Hybrid

Legend Biotech is seeking a Manager, Regulatory CMC as part of the Regulatory Affairs team based in Somerset, NJ. Role Overview This position will support the development and execution of global CMC ...

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Us tech Solutions

CMC Regulatory Manager

Morristown, NJ · On-site

The person will be responsible for the creation and maintenance of regulatory CMC documents in the controlled document management repository. The job purpose is to prepare technical CMC registration ...

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Cmc Regulatory information

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$15

$34

$145

How much do cmc regulatory jobs pay per hour?

As of Aug 23, 2026, the average hourly pay for cmc regulatory in the United States is $34.60, according to ZipRecruiter salary data. Most workers in this role earn between $22.36 and $26.20 per hour, depending on experience, location, and employer.

What is a CMC Regulatory professional?

CMC Regulatory professionals are experts who manage the Chemistry, Manufacturing, and Controls (CMC) aspects of pharmaceutical and biotechnology product development. They ensure that the information provided to regulatory authorities about the manufacturing process, quality control, and product specifications meets all necessary guidelines and standards. Their work is essential for obtaining and maintaining approval for drugs and biologics, as they prepare and review documentation for regulatory submissions such as INDs, NDAs, and MAAs. CMC Regulatory professionals collaborate closely with manufacturing, quality assurance, and research teams to ensure product consistency, safety, and compliance throughout the product lifecycle.

What are some common challenges faced by CMC Regulatory professionals when coordinating between cross-functional teams?

CMC Regulatory professionals often work closely with teams such as manufacturing, quality assurance, analytical development, and R&D. One common challenge is ensuring that all technical documents and data align with ever-evolving regulatory requirements across different regions. Coordinating timely updates and clarifications between departments can be complex, especially when timelines are tight or project scopes change. Effective communication and proactive project management are essential for navigating these challenges and maintaining compliance throughout the product lifecycle.

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

To thrive as a CMC Regulatory professional, you need a deep understanding of chemistry, manufacturing, and controls (CMC) principles, regulatory guidelines, and scientific documentation, often supported by a degree in life sciences or pharmacy. Familiarity with regulatory submission tools (such as eCTD), knowledge of ICH guidelines, and experience with global regulatory systems are typically required. Strong project management, communication, and analytical thinking skills help professionals excel in cross-functional teams and manage complex regulatory requirements. These competencies ensure accurate submissions, regulatory compliance, and successful product approvals within the pharmaceutical industry.

What is the difference between Cmc Regulatory vs Cmc Regulatory?

AspectCmc Regulatory

Since the comparison is with itself, the focus is on clarifying roles within Cmc Regulatory. Typically, Cmc Regulatory professionals handle drug registration, compliance, and documentation related to Chemistry, Manufacturing, and Controls (CMC). They work in pharmaceutical or biotech industries, ensuring products meet regulatory standards. Their responsibilities include preparing submission dossiers, liaising with regulatory agencies, and maintaining compliance throughout product lifecycle. The role requires knowledge of regulatory guidelines, scientific understanding of drug development, and relevant certifications.

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Cmc Regulatory jobs near you
Infographic showing various Cmc Regulatory job openings in the United States as of August 2026, with employment types broken down into 2% As Needed, 86% Full Time, 9% Part Time, and 3% Contract. Highlights an 89% Physical, 4% Hybrid, and 7% Remote job distribution, with an average salary of $71,960 per year, or $34.6 per hour.

Director, Global CMC Regulatory

Revolution Medicines

Remote

$153K - $202K/yr

Full-time

Re-posted 14 days ago

Job description

The Opportunity:

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 approvals for RevMed's product portfolio worldwide.

This position provides leadership for commercial-stage CMC regulatory activities, including original marketing applications, global expansions, and post-approval lifecycle management. This role requires deep expertise in global commercial CMC regulatory frameworks, strong cross-functional leadership, and the ability to proactively anticipate regulatory risks while enabling business objectives.

Responsibilities:

  • Develop and lead execution of effective global CMC regulatory strategies to support initial marketing approvals and lifecycle management of RevMed's product portfolio.

  • Oversee the preparation and submission of high-quality CMC dossiers for global marketing authorization applications and post-approval supplements/variations. Manage/lead interactions with Health Authorities as needed.

  • Assess the global regulatory implications of proposed CMC changes and provide proactive, risk-based guidance to optimize implementation and maintain compliance.

  • Interpret and apply global CMC regulatory guidance (FDA, EMA, ICH, PMDA, NMPA, MHRA, etc.) to ensure compliant and efficient regulatory pathways.

  • Anticipate regulatory risks and proactively develop mitigation strategies aligned with commercial timelines.

  • Partner with Regulatory Affairs, technical SMEs, and CROs to ensure alignment of global submission strategies while addressing region-specific CMC requirements and serve as the CMC regulatory representative on global commercial teams to provide guidance that enables efficient global execution.

  • Provide strategic leadership, mentorship, and technical guidance to junior team members to foster professional development and team performance.

Required Skills, Experience and Education:

  • Bachelor's degree in Pharmaceutical Science, Chemistry, Chemical Engineering, or closely related scientific discipline.

  • Minimum of 15 years of experience in pharmaceutical / biotech drug development, including at least 5 years of hands-on global CMC regulatory affairs experience.

  • Deep expertise in CMC development for new chemical entities (NCEs) and small molecules, with proven ability to manage complex technical content.

  • Extensive experience leading global CMC regulatory strategy and global marketing approval applications across the US, Canada, Europe, UK, APAC, and LATAM regions.

  • Strong knowledge of US and international GMP regulations, current industry practices, with a demonstrated ability to interpret and apply requirements across the product lifecycle.

  • Proven track record of building and maintaining productive relationships with global Health Authorities, including direct interactions with the FDA and other regulatory bodies.

  • Strong project and team leadership capabilities, with the ability to prioritize effectively, manage multiple complex programs, and foster cross-functional collaboration.

  • Effective written and verbal communication skills and interpersonal skills.

  • A collaborative, high-energy team player who thrives in a fast-paced, dynamic environment and embraces innovation and continuous improvement.

Preferred Skills:

  • Advanced degree (MS or Ph.D) in Pharmaceutical Science, Chemistry, Chemical Engineering, or closely related field.

  • Experience supporting global commercial labeling implementation and lifecycle updates, with strong knowledge of global labeling requirements and artwork development/approval processes, including coordination of CMC-related labeling impacts across regions.

  • Prior experience in oncology product commercialization is a plus. 

    #LI-Hybrid #LI-CT1

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