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 ...
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 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 ...
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 ...
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 ...
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 ...
Advise clients on comparability, change management, regulatory commitments, CMC compliance, and post-approval lifecycle strategies. * Represent Regulatory CMC on cross-functional teams and partner ...
New
Advise clients on comparability, change management, regulatory commitments, CMC compliance, and post-approval lifecycle strategies. * Represent Regulatory CMC on cross-functional teams and partner ...
New
Manager, Regulatory CMC
Somerset, NJ · Hybrid
Legend Biotech is seeking a Manager, Regulatory CMC as part of the Regulatory Affairs team based in Somerset, NJ. Role Overview This position will support the development and execution of global CMC ...
Manager, Regulatory CMC
Somerset, NJ · Hybrid
Legend Biotech is seeking a Manager, Regulatory CMC as part of the Regulatory Affairs team based in Somerset, NJ. Role Overview This position will support the development and execution of global CMC ...
Execute Lifecycle Management (LCM) strategy and submissions of marketed products with a focus in the international regions. * Planning and execution of international regulatory CMC submissions ...
Execute Lifecycle Management (LCM) strategy and submissions of marketed products with a focus in the international regions. * Planning and execution of international regulatory CMC submissions ...
The Chemistry Manufacturing Controls Manager will support the execution of cell and gene therapy regulatory CMC strategies for marketed products. This role contributes to the planning, preparation ...
The Chemistry Manufacturing Controls Manager will support the execution of cell and gene therapy regulatory CMC strategies for marketed products. This role contributes to the planning, preparation ...
The Chemistry Manufacturing Controls Manager - Device will support the execution of global regulatory CMC strategies for marketed and development drug-device combination products. This role ...
The Chemistry Manufacturing Controls Manager - Device will support the execution of global regulatory CMC strategies for marketed and development drug-device combination products. This role ...
Senior Manager, Global Regulatory Affairs CMC
$134K - $202K/yr
The Senior Manager Regulatory CMC (RCMC) is responsible and accountable for driving all CMC regulatory activities including development, authoring and ownership of the CMC dossier Strategy Document ...
Senior Manager, Global Regulatory Affairs CMC
$134K - $202K/yr
The Senior Manager Regulatory CMC (RCMC) is responsible and accountable for driving all CMC regulatory activities including development, authoring and ownership of the CMC dossier Strategy Document ...
Associate Manager CMC Regulatory Compliance
Billerica, MA · On-site
$77K - $116K/yr
As the Associate Manager Regulatory CMC (RCMC), you are responsible for supporting all CMC regulatory activities including development, authoring and ownership of the CMC dossier Strategy Document ...
Associate Manager CMC Regulatory Compliance
Billerica, MA · On-site
$77K - $116K/yr
As the Associate Manager Regulatory CMC (RCMC), you are responsible for supporting all CMC regulatory activities including development, authoring and ownership of the CMC dossier Strategy Document ...
Senior Manager, Global Regulatory Affairs CMC
Billerica, MA · On-site
$134K - $202K/yr
The Senior Manager Regulatory CMC (RCMC) is responsible and accountable for driving all CMC regulatory activities including development, authoring and ownership of the CMC dossier Strategy Document ...
Senior Manager, Global Regulatory Affairs CMC
Billerica, MA · On-site
$134K - $202K/yr
The Senior Manager Regulatory CMC (RCMC) is responsible and accountable for driving all CMC regulatory activities including development, authoring and ownership of the CMC dossier Strategy Document ...
Legend Biotech is seeking a Manager, Regulatory CMC as part of the Regulatory Affairs team based in Somerset, NJ. Role OverviewThis position will support the development and execution of global CMC ...
Legend Biotech is seeking a Manager, Regulatory CMC as part of the Regulatory Affairs team based in Somerset, NJ. Role OverviewThis position will support the development and execution of global CMC ...
Associate Manager CMC Regulatory Compliance
$77K - $116K/yr
As the Associate Manager Regulatory CMC (RCMC), you are responsible for supporting all CMC regulatory activities including development, authoring and ownership of the CMC dossier Strategy Document ...
Associate Manager CMC Regulatory Compliance
$77K - $116K/yr
As the Associate Manager Regulatory CMC (RCMC), you are responsible for supporting all CMC regulatory activities including development, authoring and ownership of the CMC dossier Strategy Document ...
Director, Regulatory - CMC
San Francisco, CA · On-site
$176K - $233K/yr
... management. Key Responsibilities * Lead and develop CMC regulatory strategies to support clinical ... development and commercialization * Prepare and review regulatory submissions (INDs, NDAs, BLAs ...
Quick apply
Director, Regulatory - CMC
San Francisco, CA · On-site
$176K - $233K/yr
... management. Key Responsibilities * Lead and develop CMC regulatory strategies to support clinical ... development and commercialization * Prepare and review regulatory submissions (INDs, NDAs, BLAs ...
Manager, Regulatory CMC
Somerset, NJ · On-site
Legend Biotech is seeking a Manager, Regulatory CMC as part of the Regulatory Affairs team based in Somerset, NJ. Role Overview This position will support the development and execution of global CMC ...
Manager, Regulatory CMC
Somerset, NJ · On-site
Legend Biotech is seeking a Manager, Regulatory CMC as part of the Regulatory Affairs team based in Somerset, NJ. Role Overview This position will support the development and execution of global CMC ...
Director, Regulatory CMC
Somerville, MA · Hybrid
$163K - $216K/yr
Manage regulatory CMC activities supporting commercial manufacturing, supply continuity, and inspection readiness, including drafting responses to health authority questions and commitments
Director, Regulatory CMC
Somerville, MA · Hybrid
$163K - $216K/yr
Manage regulatory CMC activities supporting commercial manufacturing, supply continuity, and inspection readiness, including drafting responses to health authority questions and commitments
Director, Regulatory CMC
Boston, MA · On-site
$182K - $275K/yr
As part of the growing and dynamic regulatory affairs team, this role is accountable for the effective management and timely delivery of CMC regulatory documents, coordination of cross-functional ...
Director, Regulatory CMC
Boston, MA · On-site
$182K - $275K/yr
As part of the growing and dynamic regulatory affairs team, this role is accountable for the effective management and timely delivery of CMC regulatory documents, coordination of cross-functional ...
Executive Director, Regulatory Affairs, CMC
$153K - $202K/yr
The position manages a U.S.-based team of approximately 15 reports and reports to the Global Head of Regulatory CMC. Essential Functions of the job: * Lead, develop, and continuously strengthen the U.
Executive Director, Regulatory Affairs, CMC
$153K - $202K/yr
The position manages a U.S.-based team of approximately 15 reports and reports to the Global Head of Regulatory CMC. Essential Functions of the job: * Lead, develop, and continuously strengthen the U.
Director, Regulatory CMC
Boston, MA · On-site
As part of the growing and dynamic regulatory affairs team, this role is accountable for the effective management and timely delivery of CMC regulatory documents, coordination of cross-functional ...
Quick apply
Director, Regulatory CMC
Boston, MA · On-site
As part of the growing and dynamic regulatory affairs team, this role is accountable for the effective management and timely delivery of CMC regulatory documents, coordination of cross-functional ...
Executive Director, Regulatory Affairs, CMC
$153K - $202K/yr
The position manages a U.S.-based team of approximately 15 reports and reports to the Global Head of Regulatory CMC. Essential Functions of the job: * Lead, develop, and continuously strengthen the U.
Executive Director, Regulatory Affairs, CMC
$153K - $202K/yr
The position manages a U.S.-based team of approximately 15 reports and reports to the Global Head of Regulatory CMC. Essential Functions of the job: * Lead, develop, and continuously strengthen the U.
Regulatory Cmc Manager information
See salary details
$54.5K - $66.1K
12% of jobs
$75.8K is the 25th percentile. Wages below this are outliers.
$66.1K - $77.7K
16% of jobs
$77.7K - $89.3K
11% of jobs
The median wage is $94.2K / yr.
$89.3K - $100.9K
28% of jobs
$100.9K - $112.5K
5% of jobs
$122.6K is the 75th percentile. Wages above this are outliers.
$112.5K - $124K
4% of jobs
$124K - $135.6K
4% of jobs
$135.6K - $147.2K
2% of jobs
$147.2K - $158.8K
1% of jobs
$158.8K - $170.4K
4% of jobs
$170.4K - $182K
13% of jobs
$54.5K
$110.7K
$182K
How much do regulatory cmc manager jobs pay per year?
As of Aug 31, 2026, the average yearly pay for regulatory cmc 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 the difference between Regulatory Cmc Manager vs Regulatory Cmc Specialist?
| Aspect | Regulatory Cmc Manager | Regulatory Cmc Specialist |
|---|---|---|
| Credentials | Bachelor's or Master’s in Life Sciences, Regulatory Affairs certification often preferred | Similar credentials, often with specialized regulatory certifications |
| Work Environment | Leads teams, manages projects, interacts with cross-functional departments | Supports regulatory submissions, conducts research, and prepares documentation |
| Industry Usage | Used in pharmaceutical and biotech companies for overseeing CMC strategies | Commonly found in regulatory affairs departments supporting CMC activities |
The Regulatory Cmc Manager typically holds a leadership role, overseeing CMC regulatory strategies and teams, while the Regulatory Cmc Specialist focuses on supporting documentation and research tasks. Both roles require similar credentials and are integral to pharmaceutical regulatory processes, but differ mainly in scope and responsibility.
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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
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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.
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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
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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
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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
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Thanks & Regards,
Mayank Gupta, (M. Pharmacy)
(Lead Pharma Technical Recruiter)
10 Exchange Place, Suite 1710, Jersey City, NJ 07302
Direct: (412)-385-4143
Tel:Â (201) 524 9600 Ext 7797
Whats app: (412)-385-4143
Additional Information
All your information will be kept confidential according to EEO guidelines.
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