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Cmc Regulatory Jobs (NOW HIRING)

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 ...

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 ...

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 ...

Altimmune

CMC Director, Regulatory Affairs

Morristown, NJ · Remote

$153K - $202K/yr

Responsible for high-quality CMC regulatory submissions in support of approval of global marketing and clinical trial applicationsManages all aspects of regulatory CMC activities, assists in the ...

Rhythm Pharmaceuticals

Director, Regulatory CMC

Boston, MA · On-site

$182K - $275K/yr

This individual contributor role will execute regulatory CMC plans and support implementation of filing strategies for assigned programs. As part of the growing and dynamic regulatory affairs team ...

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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 21, 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.

Associate Director or Director, CMC Regulatory Affairs

Atsena

Durham, NC • On-site

$180 - $260/hr

Other

Re-posted 6 days ago

Job description

Position Summary

The Associate Director / Director, CMC Regulatory Affairs will lead global CMC regulatory strategy and execution for the company’s gene therapy programs from early research through clinical development and commercialization. This role is responsible for developing CMC regulatory strategies across product development stages, supporting regulatory submissions, and serving as the regulatory liaison to internal CMC teams and external contract manufacturing organizations.

The individual will work cross-functionally with process development, analytical development, manufacturing, quality, and program leadership to ensure that CMC development plans meet regulatory expectations for gene therapy products. The role will also support interactions with global regulatory authorities such as the U.S. Food and Drug Administration and the European Medicines Agency.

Key Responsibilities CMC Regulatory Strategy
  • Develop and implement global CMC regulatory strategies for gene therapy programs from early development through clinical stages and commercialization.
  • Provide regulatory guidance on viral vector manufacturing, process development, analytical characterization, and product comparability.
  • Assess regulatory risks related to manufacturing changes and propose mitigation strategies.
Regulatory Submissions
  • Lead preparation and review of CMC sections of global regulatory submissions, including: INDs and IND amendments, CTAs and IMPDs, BLA/MAA submissions and supplements, annual reports and regulatory updates
  • Ensure submissions meet regulatory expectations for gene therapy products.
Health Authority Interactions
  • Prepare CMC regulatory briefing documents and support agency meetings.
  • Serve as the subject matter expert for CMC topics during interactions with agencies including the FDA and EMA.
  • Coordinate and author responses to regulatory agency questions related to CMC.
Cross-Functional Collaboration
  • Partner closely with internal teams including: Process Development, Analytical Development, Manufacturing, Quality
  • Serve as the CMC regulatory representative on cross-functional program teams.
  • Provide regulatory guidance for manufacturing changes, comparability strategies, and lifecycle management.
Regulatory Intelligence & Compliance
  • Monitor evolving regulatory guidance related to gene therapy and advanced biologics.
  • Interpret regulatory requirements and communicate implications to internal teams.
  • Support development of internal regulatory policies and processes.
Qualifications Education
  • PhD or MS in biochemistry, molecular biology, chemical engineering, pharmaceutical sciences, or related field.
Preferred Qualifications
  • Direct experience with AAV, lentiviral, or other gene therapy platforms.
  • Experience supporting late-stage development or BLA/MAA submissions.
  • Familiarity with global regulatory frameworks for advanced therapy medicinal products (ATMPs).
  • Prior experience participating in regulatory meetings.
Associate Director Experience
  • 7–10 years of experience in regulatory affairs and CMC.
  • Experience contributing to CMC sections of IND/CTA submissions.
Director Experience
  • 10–15+ years of experience in regulatory affairs with leadership responsibility for CMC regulatory strategy.
  • Demonstrated experience leading CMC regulatory submissions and health authority interactions.
Knowledge & Skills
  • Strong knowledge of global CMC regulatory requirements for biologics and gene therapies.
  • Understanding of viral vector manufacturing processes.
  • Experience with analytical characterization, comparability, and manufacturing changes.
  • Excellent regulatory writing and communication skills.
  • Ability to work effectively in a fast-paced startup environment.
Key Competencies
  • Strategic thinking and problem solving
  • Strong scientific and regulatory expertise
  • Cross-functional leadership
  • Excellent communication and collaboration skills
  • Ability to manage multiple programs and timelines
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