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Cmc Regulatory Jobs (NOW HIRING)

Dyne Therapeutics

Director, Regulatory CMC

Waltham, MA · On-site

$161K - $213K/yr

The Director, Regulatory Affairs - Chemistry, Manufacturing, and Controls (CMC) is responsible for defining and executing global CMC regulatory strategies for Dyne programs across all stages of ...

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 ...

Recursion

Director, CMC Regulatory Affairs

New York, NY · Remote

$207K - $255K/yr

Lead development and implementation of CMC regulatory strategy for small molecule investigational drugs in global Phase 1-3 clinical trials and marketing applications. * Influence the regulatory ...

Altimmune

CMC Director, Regulatory Affairs

Morristown, NJ · On-site

$154K - $204K/yr

This individual will be responsible for providing global regulatory CMC support throughout the product lifecycle (e.g., regulatory strategies, preparing CMC filings and submissions to regulatory ...

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All JobsCmc Regulatory Jobs

Cmc Regulatory information

See salary details

$15

$34

$145

How much do cmc regulatory jobs pay per hour?

As of Aug 3, 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 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.

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 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 CMC Regulatory professionals?

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.
More about Cmc Regulatory jobs
What cities are hiring for Cmc Regulatory jobs? Cities with the most Cmc Regulatory job openings:
What are the most commonly searched types of Cmc Regulatory jobs? The most popular types of Cmc Regulatory jobs are:
What states have the most Cmc Regulatory jobs? States with the most job openings for Cmc Regulatory jobs include:
What job categories do people searching Cmc Regulatory jobs look for? The top searched job categories for Cmc Regulatory jobs are:
Cmc Regulatory jobs near you
Infographic showing various Cmc Regulatory job openings in the United States as of July 2026, with employment types broken down into 4% Locum Tenens, 4% Internship, 1% As Needed, 76% Full Time, 13% Part Time, and 2% Contract. Highlights an 92% Physical, 3% Hybrid, and 5% Remote job distribution, with an average salary of $71,960 per year, or $34.6 per hour.

Director, CMC Regulatory

Corvus Pharmaceutical

South San Francisco, CA • On-site

Full-time

Posted 20 days ago

Job description

Corvus Pharmaceutical is a clinical-stage biopharmaceutical company developing novel therapies with the potential to significantly improve the treatment of immune diseases and cancer.  Our lead program, Soquelitnib, is a first-in-class, oral therapy that selectively inhibits ITK to modulate and control parallel signaling pathways in the immune system.

Reporting to the Vice President of Regulatory Affairs, the Director of Regulatory Affairs CMC will serve as a key member of the Regulatory organization, responsible for developing and executing global Chemistry, Manufacturi ng, and Controls (CMC) regulatory strategies for clinical-stage small molecule programs. 
This individual will partner cross-functionally with CMC, Technical Operations, Quality, and Clinical teams to ensure timely, compliant, and high-quality regulatory submissions and lifecycle management activities.

ROLE AND RESPONSIBILITIES

• Develop and execute global CMC regulatory strategies across all phases of development (IND/CTA through 

NDA/MAA and lifecycle management)

• Provide strategic input and regulatory guidance on manufacturing changes, comparability approaches, and 

control strategies

• Anticipate regulatory risks and propose mitigation strategies aligned with agency expectations (e.g. FDA, 

EMA, Health Canada, PMDA)

• Lead preparation and authorship of CMC sections (Module 2.3, 3) for: INDs/CTAs/Amendments

• Lead preparation of CMC Briefing documents and health authority interactions

• NDA/MAA and supplements/variations preparation and submissions

• Ensure alignment of CMC documentation with overall regulatory strategy and program timelines

• Oversee document quality, consistency, and compliance with global regulatory requirements

• Represent regulatory in change control assessments

• Support inspection readiness activities in collaboration with Quality and Manufacturing teams

QUALIFICATIONS AND EDUCATION REQUIREMENTS

• Bachelor’s degree in life sciences or related field required; advanced degree (MS, PhD, PharmD) preferred

• Minimum of 10+ years of regulatory affairs experience in biotech/pharma

PREFERRED SKILLS

• Experience supporting small molecules required (familiarity with additional modalities

desirable).

• Experience with IND/CTA, NDA/MAA compilation and submissions.

• Deep knowledge of CMC development for small molecules, Module 3 structure and 

expectations, and comparability and change management strategies.

• Familiarity with global regulatory frameworks (FDA, EMA, ICH guidelines)

• Proven ability to operate effectively in a small, fast-paced biotech environment

• Strong cross-functional leadership and influencing skills without direct authority

• Excellent written and verbal communication skills, with the ability to translate complex CMC topics into clear regulatory strategies

Salary Range: $230,000 to $270,000

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