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Regulatory Cmc Project Manager Jobs (NOW HIRING)

Jobtailor

Director, CMC Project Management

Cambridge, MA · On-site

Integrate activities across Technical Operations, Regulatory, Finance, and Legal * Leverage AI ... Communicate CMC project status, risks, and mitigation plans Requirements * MS or BS in a scientific ...

New

ProKidney

Director, CMC Project Management

The Director, CMC Project Management will be responsible for managing activities related to CMC ... CMC regulatory submissions, coordinating the planning and on-time completion of CMC activities ...

New

ProKidney

Director, CMC Project Management

The Director, CMC Project Management will be responsible for managing activities related to CMC ... CMC regulatory submissions, coordinating the planning and on-time completion of CMC activities ...

New

Vaxcyte

Associate Director, Regulatory CMC

San Carlos, CA · On-site +1

$180K - $210K/yr

Manages interactions with Health Authorities for CMC topics. Provides regulatory CMC guidance to ... Leads projects with cross-functional teams and acts as the primary regulatory CMC contact for ...

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Regulatory Cmc Project Manager information

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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:

Director, Regulatory CMC

San Diego, CA • On-site

IMMUNEERING CORPORATION
Biotechnology Research and Development • 11 - 50 employees
Learn more about IMMUNEERING CORPORATIONexternal

$235K - $270K/yr

Full-time

Posted 12 days ago

Key responsibilities

  • Develop and lead global CMC regulatory strategies for investigational and commercial products to ensure timely submissions and approvals.

  • Prepare, review, and submit CMC sections of regulatory documents including INDs, IMPDs, NDAs, BLAs, ANDAs, and supplements to FDA and other regulatory authorities.

  • Provide regulatory guidance on CMC matters to project teams, including manufacturing changes, process development, and technology transfers.

Job description

ABOUT IMMUNEERING

Immuneering Corporation (Nasdaq: IMRX) is a clinical-stage biopharmaceutical company developing oncology therapies using its proprietary Deep Cyclic Inhibition platform. Our lead asset, atebimetinib (IMM-1-104), is an oral, once-daily Deep Cyclic Inhibitor of MEK in active Phase 2 and Phase 3 (MAPKeeper 301) clinical trials in pancreatic cancer and RAS-mutant non-small cell lung cancer, as well as additional solid tumor programs. We are committed to delivering transformative treatments to patients with limited options through rigorous science and a collaborative, mission-driven culture.


Primary Responsibilities

The Director/Senior Director, Regulatory CMC (Chemistry, Manufacturing, and Controls) is a pivotal regulatory role responsible for developing and executing regulatory strategies for CMC activities across the company's clinical product portfolio. This position ensures compliance with all applicable regulatory requirements and works cross-functionally to support product development, registration, and lifecycle management. A successful candidate will be a highly collaborative individual with strong interpersonal skills and an exceptional team player with the ability to lead Regulatory CMC.

•    Develop and lead global CMC regulatory strategies for investigational and commercial products to ensure timely submissions and approvals.

•    Prepare, review, and submit CMC sections of regulatory documents including INDs, IMPDs, NDAs, BLAs, ANDAs, and supplements to FDA and other regulatory authorities including the EMA.

•    Provide regulatory guidance on CMC matters to project teams, including manufacturing changes, process development, and technology transfers.

•    Monitor and interpret current and emerging CMC regulatory requirements, guidelines, and trends to proactively address potential impacts.

•    Represent Regulatory CMC in cross-functional teams and meetings, providing expertise and input on regulatory implications of manufacturing and quality changes.

•    Lead interactions and communications with regulatory agencies regarding CMC topics, e.g., pre-IND, end-of-phase, and pre-submission meetings.

•    Work with a sense of purpose to get work done using influence and good project management skills, fostering alignment with organizational goals.

•    Collaborate with Quality, CMC, R&D, Finance, Legal, Clinical, and other internal departments to ensure regulatory compliance and readiness; partner effectively with CROs and consultants.

Qualifications

Education

•    Bachelor's degree in Chemistry, Pharmacy, Life Sciences, or a related field required; advanced degree (PhD, PharmD, MS) highly preferred.

Technical / Soft Skills

•    Minimum of 10+ years of experience in CMC regulatory affairs within the biopharmaceutical or pharmaceutical industry, including experience with small molecule development in oncology; more experience is a plus.

•    Proven track record of successful CMC submissions and approvals in the US and internationally.

•    In-depth knowledge of FDA, EMA, and ICH guidelines, regulations, and processes related to CMC.

•    Strong leadership, communication, and project management skills.

•    Must be focused on working collaboratively and within our values of: Data rules, All-in, Own it (Accountable), Caring and Humble.

•    Ability to work effectively in a collaborative, fast-paced environment.


WHAT WE OFFER

  • The opportunity to build and lead a critical function at a pivotal inflection point in Immuneering's clinical journey.
  • A collaborative, science-first culture that values expertise, initiative, and patient impact.
  • Competitive compensation, equity participation, and exceptional benefits.
  • Fully remote work environment with a flexible, results-oriented culture.

EQUAL OPPORTUNITY EMPLOYER

Immuneering Corporation is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, or any other characteristic protected by law.