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Quality Regulatory Manager Jobs (NOW HIRING)

Us tech Solutions

CMC Regulatory Manager

Morristown, NJ · On-site

... regulatory CMC documents in the controlled document management repository. The job purpose is to ... Lead the development of technical documents to ensure the on-time compilation of high quality CTD ...

Deep Foods

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FSVP/Regulatory Compliance Specialist

Union, NJ · On-site

$80K - $100K/yr

Director of Quality/Regulatory Manager Location: Union, NJ Key responsibilities Standard Hours: 10:00 AM - 6:00 PM but flexible. This is not a remote position, and requires international travel to ...

David Protein

Regulatory Document Analyst

New York, NY · On-site

$75K - $85K/yr

... Quality team. You'll help ensure our products meet regulatory and customer compliance requirements by managing supplier documentation, coordinating with external partners, and supporting cross ...

BEPC INC

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Quality & Regulatory Compliance Manager - Medical Devices

Mountain View, CA · On-site

$85 - $100/hr

Current knowledge and practical experience with FDA Quality Management System Regulation (QMSR), including the transition from legacy Quality System Regulation (QSR) requirements. * Demonstrated ...

Alexza

VP Quality & Regulatory Affairs

Fremont, CA · On-site

Provide strategic leadership and advise executive management and the Board on quality, compliance, regulatory, and quality culture. Develop and execute the company's global Quality strategy aligned ...

Creation

Senior Global Regulatory Manager

Reporting directly to the Senior Director of Global Quality, this highly visible position will ... The Global Regulatory Manager will help lead global quality initiatives, support internal and ...

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Quality Regulatory Manager information

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$24K

$86.2K

$158K

How much do quality regulatory manager jobs pay per year?

As of Sep 2, 2026, the average yearly pay for quality regulatory manager in the United States is $86,159.00, according to ZipRecruiter salary data. Most workers in this role earn between $44,000.00 and $136,000.00 per year, depending on experience, location, and employer.

What is a quality regulatory manager?

A Quality Regulatory Manager is a professional responsible for ensuring that a company's products and processes comply with industry regulations, standards, and quality requirements. They oversee the implementation of quality management systems, prepare for regulatory audits, and keep the organization updated on changing regulations. This role often involves working closely with various departments to ensure documentation, processes, and products meet both internal and external compliance standards. Quality Regulatory Managers play a critical part in maintaining the company's reputation and ability to operate within legal guidelines.

How does a quality regulatory manager typically collaborate with cross-functional teams to ensure compliance?

A Quality Regulatory Manager works closely with departments such as manufacturing, R&D, and supply chain to interpret and implement regulatory requirements across the organization. Regular meetings and clear communication are essential to align quality systems with evolving regulations and address compliance gaps. The manager often leads training sessions, reviews documentation, and coordinates audits, ensuring all teams understand and adhere to quality standards. This collaborative approach helps maintain product safety and supports successful regulatory submissions.

What are the key skills and qualifications needed to thrive as a quality regulatory manager, and why are they important?

To thrive as a Quality Regulatory Manager, you need in-depth knowledge of quality management systems, regulatory compliance, and industry standards, typically backed by a relevant degree and experience in regulated environments. Familiarity with ISO standards, FDA regulations, audit management tools, and certifications like CQE or RAC is highly valued. Strong analytical thinking, attention to detail, and effective communication are critical soft skills for collaborating across departments and ensuring compliance. These skills and qualifications are essential to maintain product quality, meet regulatory requirements, and mitigate compliance risks within an organization.

What is the difference between Quality Regulatory Manager vs Quality Assurance Specialist?

AspectQuality Regulatory ManagerQuality Assurance Specialist
CertificationsISO 13485, Regulatory Affairs certificationsISO 9001, QA certifications
Work EnvironmentRegulatory agencies, compliance departmentsManufacturing, production, quality labs
Employer & Industry UsageMedical devices, pharmaceuticals, biotechManufacturing, consumer products, electronics

The Quality Regulatory Manager focuses on ensuring products meet regulatory standards and manages compliance documentation, often working closely with regulatory agencies. In contrast, the Quality Assurance Specialist primarily ensures product quality through testing and process audits. Both roles require quality certifications but differ in their focus areas and work environments.

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Quality Regulatory Manager jobs near you
Infographic showing various Quality Regulatory Manager job openings in the United States as of August 2026, with employment types broken down into 1% As Needed, 81% Full Time, 14% Part Time, 3% Contract, and 1% Nights. Highlights an 91% Physical, 1% Hybrid, and 8% Remote job distribution, with an average salary of $86,159 per year, or $41.4 per hour.

CMC Regulatory Manager

Us tech Solutions

Morristown, NJ • On-site

Contractor

Re-posted 5 days ago

Job description

Company Description

US Tech Solutions is a global staff augmentation firm providing a wide-range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit our website http://www.ustechsolutions.com/.We are constantly on the lookout for professionals to fulfill the staffing needs of our clients, and we currently have a job opening that may interest you

Job Description

Title: CMC Manager

Duration: 12 Months

Location: Morristown, NJ 07962

 

Job Description:

The CMC Documentation Team is responsible for the development of Chemistry, Manufacturing and Control (Module 3) documentation for the commercial products within the portfolio. Under the broad guidance of the CMC product leads, the job entails supporting the CMC Documentation team in the preparation of CMC registration documents. 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 documents in order to maintain the existing marketing authorization (i.e. dossier updates, variations, renewals, response to deficiency letters, compliance gap closures) in various countries where business is being conducted. In addition, the candidate might also support new product development projects.

 

Qualifications

Position Duties & Responsibilities

  • Lead the development of technical documents to ensure the on-time compilation of high quality CTD Module 3 and QOS documents that are ready for submission
  • Discuss and align with project team on strategy for maintenance activities for products under his or her responsibility
  • Evaluate change requests with a goal of defining technical requirements according to guidelines, and evaluate and provide input on technical data to support the change.
  • Create or update the technical registration dossiers (CTD Module 3 and QOS or equivalent) of pharmaceutical products
  • Maintain knowledge of current industry requirements and standards for CTD Module 3 and QOS or equivalent
  • Work cross functionally to coordinate the preparation of draft responses to technical regulatory questions from health authorities including writing of expert statements and scientific justifications

 

Requirements/Preferences

Education Requirement(s):

  • Bachelor's degree with 4 or more years of proven experience
  • Master's degree with 2 or more years of proven experience

 

Skill & Competency Requirements:

  • Experience in global CMC/Module 3 creation
  • Demonstrated ability/experience analyzing technical reports (manufacturing, analytical and stability)
  • Experienced in the US regulatory environment
  • Experience in post-approval CMC changes
  • Fluent in English
  • Excellent writing skills
  • Demonstrated ability/experience managing IT based scientific systems

  

Thanks & Regards,

Mayank Gupta, (M. Pharmacy)

(Lead Pharma Technical Recruiter)

10 Exchange Place, Suite 1710, Jersey City, NJ 07302

Direct: (412)-385-4143

Tel:  (201) 524 9600 Ext 7797

Whats app: (412)-385-4143

Additional Information

All your information will be kept confidential according to EEO guidelines.

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About US Tech Solutions

Sourced by ZipRecruiter

US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions.

Industry

It services

Company size

1,001 - 5,000 Employees

Headquarters location

Jersey City, NJ, US

Year founded

2000

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