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Regulatory Cmc Project Manager Jobs (NOW HIRING)

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CMC Project Manager

Belgium, WI · On-site

As a CMC Project Manager at ICON, you will be responsible for leading and managing regulatory affairs CMC projects, ensuring successful execution and delivery of project objectives. This role is ...

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 ... Strong project management and organizational skills. * Ability to manage multiple programs and ...

Intuitive

Project Manager, CMC

Sunnyvale, CA · On-site

Reporting to the Program Management & Operations organization, the CMC Project Manager partners with CMC, Manufacturing, Analytical Development, Quality, Regulatory Affairs, Supply Chain, Clinical ...

Legend Biotech USA, Inc.

Legend Biotech is seeking a Manager, Regulatory CMC as part of the Regulatory Affairs team based in ... Strong project management and organizational skills.Ability to manage multiple programs and ...

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Regulatory Cmc Project Manager information

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$110.7K

$182K

How much do regulatory cmc project manager jobs pay per year?

As of Sep 13, 2026, the average yearly pay for regulatory cmc project manager in the United States is $110,733.00, according to ZipRecruiter salary data. Most workers in this role earn between $77,500.00 and $136,500.00 per year, depending on experience, location, and employer.

What is a Regulatory CMC Project Manager?

A Regulatory CMC (Chemistry, Manufacturing, and Controls) Project Manager is a professional responsible for overseeing and coordinating the regulatory aspects of drug development related to manufacturing and quality control. They ensure that all CMC documentation and processes meet regulatory requirements for submissions to health authorities such as the FDA or EMA. Their key duties include managing timelines, collaborating with cross-functional teams, and preparing regulatory submissions for new or existing pharmaceutical products. This role is crucial in ensuring that products are developed, manufactured, and distributed in compliance with global regulatory standards.

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

Regulatory CMC Project Managers often face the challenge of aligning the diverse priorities and timelines of cross-functional teams, such as R&D, quality assurance, manufacturing, and regulatory affairs. Balancing these perspectives requires strong communication and organizational skills, as well as a deep understanding of regulatory requirements. Additionally, managing changes in regulatory expectations or clinical data can impact project timelines, so adaptability and proactive risk management are essential. Building strong relationships and facilitating transparent updates are key to overcoming these challenges and ensuring project milestones are met.

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

To thrive as a Regulatory CMC Project Manager, you need a strong background in chemistry, manufacturing, and controls (CMC) regulations, project management, and a relevant degree in life sciences or pharmacy. Familiarity with regulatory submission tools (e.g., eCTD), project management software, and knowledge of global regulatory standards (FDA, EMA, ICH) are typically required. Excellent organizational skills, attention to detail, and the ability to communicate effectively across multidisciplinary teams help drive regulatory and project success. These skills ensure timely and compliant submissions, efficient project execution, and successful product approvals in a highly regulated environment.

What is the difference between Regulatory Cmc Project Manager vs Regulatory Affairs Specialist?

AspectRegulatory Cmc Project Manager

The Regulatory Cmc Project Manager focuses on managing Chemistry, Manufacturing, and Controls (CMC) activities related to drug development and registration. They coordinate cross-functional teams, ensure compliance with regulatory requirements, and oversee project timelines. In contrast, a Regulatory Affairs Specialist handles broader regulatory submissions, maintains compliance documentation, and interacts with regulatory agencies. While both roles require knowledge of regulations, the Project Manager emphasizes project coordination and CMC-specific tasks, whereas the Specialist focuses on regulatory documentation and submissions.

What are popular job titles related to Regulatory Cmc Project Manager jobs?

For Regulatory Cmc Project Manager jobs, the most frequently searched job titles are:

Manager, CMC Project Management

Waltham, MA

Crescent Biopharma
See more jobs at Crescent Biopharmaexternal

$140K - $180K/yr

Full-time

PTO

Re-posted 24 days ago

Key responsibilities

  • Lead cross-functional CMC project management for clinical-stage development programs, developing and maintaining integrated project plans, timelines, critical path activities, milestones, risks, and decision logs.

  • Drive project execution by facilitating cross-functional meetings, tracking actions and decisions, proactively identifying risks and dependencies, and escalating issues to ensure program objectives are achieved.

  • Coordinate planning and execution of CMC regulatory submissions, including INDs, IMPDs, amendments, and health authority responses, ensuring cross-functional deliverables are completed on schedule.

Job description

Crescent Biopharma’s vision is to build a world leading oncology company bringing the next wave of therapies for cancer patients. The Company’s clinical-stage pipeline includes its lead program, a PD-1 x VEGF bispecific antibody, as well as novel antibody-drug conjugates. By leveraging multiple modalities and established targets, Crescent aims to rapidly advance potentially transformative therapies as single agents and as part of combination regimens to treat a range of solid tumors. For more information, visit www.crescentbiopharma.com and follow the Company on LinkedIn and X.

We are seeking a Manager, CMC Project Management who is responsible for driving cross-functional execution of CMC activities in support of early and late-stage clinical development programs. Working closely with Technical Operations  - including Drug Substance, Drug Product, Analytical Development, Regulatory CMC, Quality, Supply Chain and external partners, this role leads integrated project planning, facilitates cross-functional alignment, manages risks and timelines, and enables successful delivery of CMC milestones in support of regulatory and development objectives. This role is based in Waltham, MA and you must have experience in the oncology space.

Responsibilities
  • Lead cross-functional CMC project management for clinical-stage development programs, developing and maintaining integrated project plans, timelines, critical path activities, milestones, risks, and decision logs.
  • Drive project execution by facilitating cross-functional meetings, tracking actions and decisions, proactively identifying risks and dependencies, and escalating issues to ensure program objectives are achieved.
  • Coordinate activities across Drug Substance, Drug Product, Analytical Development, Quality Control, Quality Assurance, Supply Chain, Regulatory CMC, and other Technical Operations functions to ensure alignment of priorities and deliverables
  • Partner with CDMOs, CROs, testing laboratories, and other external vendors to monitor deliverables, manufacturing activities, timelines, and issue resolution.
  • Coordinate planning and execution of CMC regulatory submissions, including INDs, IMPDs, amendments, and health authority responses, ensuring cross-functional deliverables are completed on schedule.
  • Support program budgeting, forecasting, resource planning, purchase order tracking, and financial reporting to enable effective execution of CMC development activities.
  • Identify and implement process improvements to strengthen CMC project execution, governance, resource planning, and organizational effectiveness.
Education & Experience
  • Bachelor’s degree in a scientific, engineering, or related discipline required.
  • 5–8 years of biotech or pharmaceutical industry experience.
  • Experience in CMC, Technical Operations, Project Management, Manufacturing, Supply Chain, or related functions.
  • Familiarity with GMP manufacturing and external partner management.
  • Strong project management and organizational skills.
  • Ability to manage multiple priorities in a fast-paced environment.
  • Excellent communication and collaboration skills.
  • Experience with project planning and tracking tools.
  • Ability to identify risks and drive issue resolution.
  • Detail-oriented with strong follow-through and accountability
What We Offer
  • Opportunity to join a mission-driven team where you'll contribute to impactful work, take on varied responsibilities, and grow quickly in a dynamic environment
  • Competitive compensation, including base salary, performance bonus, and equity
  • 100% employer-paid benefits package
  • Flexible PTO; also, two, one-week company-wide shutdowns each year
  • A commitment to your professional development, with access to resources, mentorship, and growth opportunities