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Cmc Regulatory Jobs (NOW HIRING)

Director Regulatory Affairs CMC

Fremont, CA · Hybrid

$164K - $216K/yr

Director, Regulatory CMC (Hybrid - San Francisco Bay Area) We are partnering with a well-funded, clinical-stage biotechnology company with a diversified pipeline spanning both biologics and small ...

Director Regulatory Affairs CMC

Sonoma, CA · Hybrid

$168K - $221K/yr

Director, Regulatory CMC (Hybrid - San Francisco Bay Area) We are partnering with a well-funded, clinical-stage biotechnology company with a diversified pipeline spanning both biologics and small ...

CMC Director, Regulatory Affairs

Gaithersburg, MD · On-site

$162K - $213K/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 ...

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 ...

CMC Director, Regulatory Affairs

Gaithersburg, MD · Remote

$153K - $202K/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 ...

OR · On-site

See Yourself at Telix The Manager, GRA - CMC is responsible for authoring/writing CMC specific regulatory dossiers (3.2.S and 3.2.P sections) towards the development and commercialization of ...

The CMC Regulatory Affairs Manager is responsible forsupporting the planning, coordination, and execution of CMC regulatory activities across global clinical and commercial programs. This role ...

The Director of Regulatory CMC will lead the development and execution of global CMC regulatory strategies for our pipeline of small molecules and monoclonal antibodies to accelerate clinical ...

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Cmc Regulatory information

See salary details

$15

$34

$145

How much do cmc regulatory jobs pay per hour?

As of Jun 15, 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:
Infographic showing various Cmc Regulatory job openings in the United States as of June 2026, with employment types broken down into 8% As Needed, 5% Full Time, 69% Part Time, 2% Temporary, and 16% Contract. Highlights an 91% Physical, 3% Hybrid, and 6% Remote job distribution, with an average salary of $71,960 per year, or $34.6 per hour.
Regulatory CMC Associate Manager

Regulatory CMC Associate Manager

Artech Information System LLC

East Hanover, NJ

Contractor

Posted 8 days ago


Job description

Company Description

Artech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides technical expertise to fill gaps in clients' immediate skill-sets availability, deliver emerging technology skill-sets, refresh existing skill base, allow for flexibility in project planning and execution phases, and provide budgeting/financial flexibility by offering contingent labor as a variable cost.

Job Description

Assist and support regulatory CMC managers in the following activities:

Defining global CMC regulatory strategy and decisions for development projects or marketed products to achieve optimal submission/approval results and ensure regulatory compliance.

Communicating CMC regulatory strategy, key issues and remediation activities needed throughout the project/product life cycle, to project teams and appropriate management levels within and outside of Reg CMC.

Influencing and negotiating within cross-functional teams to ensure quality submission planning and decision-making.

Single point of contact with other line functions

Review CMC regulatory documentation to ensure strategic direction and regulatory compliance are met.

Collecting documentation from other line functions to support submission preparation

Ensure databases are maintained to compliance


Qualifications

Skills:

Desirable: Experience in regulatory field, in particular regulatory CMC


Education:Degree in Science (e.g. Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent


Desirable: Advanced Degree in Science (Chemistry, Pharmacy, Biochemistry, Biotechnology) or equivalent.


Additional Information

Best Regards,

Anuj Mehta

973-967-3402


Artech logo

About Artech

Sourced by ZipRecruiter

Artech is a leading IT staffing and consulting company based in Morristown, NJ, US. Since its foundation in 1992, Artech has mastered in complementing human expertise with technology and business acumen to produce world-class staffing solutions. The company caters to diverse industry sectors, including financial services, healthcare, telecommunication, energy and utilities, supply chain, and retail. It provides IT consulting, project management, professional and staff augmentation, and managed staffing services. Artech's mission is to provide exceptional IT staffing services to its clients by comprehending their business needs and then crafting a customized staffing strategy. Its notable achievement includes being recognized as one of the largest IT staffing companies in the U.S, according to Staffing Industry Analysts (SIA).

Industry

Recruiting and staffing services

Company size

10,000+ Employees

Headquarters location

Morristown, NJ, US

Year founded

1992