CMC Regulatory Scientist
Rahway, NJ · On-site
The Senior Specialist plays a critical role in developing CMC regulatory submission strategies and establishing timelines for assigned pharmaceutical products in accordance with global regulations ...
CMC Regulatory Scientist
Rahway, NJ · On-site
The Senior Specialist plays a critical role in developing CMC regulatory submission strategies and establishing timelines for assigned pharmaceutical products in accordance with global regulations ...
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 ...
Director, Regulatory Affairs CMC
South San Francisco, CA · On-site
$189K - $237K/yr
Director, Regulatory CMC. Develop and execute global regulatory CMC strategies supporting clinical development, marketing approvals, and lifecycle management worldwide across GCC, LATAM, and APAC ...
Director, Regulatory Affairs CMC
South San Francisco, CA · On-site
$189K - $237K/yr
Director, Regulatory CMC. Develop and execute global regulatory CMC strategies supporting clinical development, marketing approvals, and lifecycle management worldwide across GCC, LATAM, and APAC ...
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 ...
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 ...
Sr. Director, Regulatory CMC
Somerville, MA · Hybrid
$163K - $216K/yr
Position Description The Senior Director, Regulatory CMC is responsible for defining and executing global CMC regulatory strategy for approved and late-stage gene therapy products, with a strong ...
Sr. Director, Regulatory CMC
Somerville, MA · Hybrid
$163K - $216K/yr
Position Description The Senior Director, Regulatory CMC is responsible for defining and executing global CMC regulatory strategy for approved and late-stage gene therapy products, with a strong ...
Overview The Senior Manager, Regulatory Affairs CMC supports the CMC team under the guidance of the Senior Director, CMC. In this role, the Senior Manager provides strategic support and coordination ...
Overview The Senior Manager, Regulatory Affairs CMC supports the CMC team under the guidance of the Senior Director, CMC. In this role, the Senior Manager provides strategic support and coordination ...
Overview The Senior Manager, Regulatory Affairs CMC supports the CMC team under the guidance of the Senior Director, CMC. In this role, the Senior Manager provides strategic support and coordination ...
Overview The Senior Manager, Regulatory Affairs CMC supports the CMC team under the guidance of the Senior Director, CMC. In this role, the Senior Manager provides strategic support and coordination ...
Director, Regulatory Affairs CMC
San Diego, CA · On-site
$189K - $237K/yr
Position Summary Director, Regulatory CMC. Hybrid role (office ~3 days/week) in San Diego, CA; San Francisco, CA; or Princeton, NJ. Primary Responsibilities * Manage CMC regulatory affairs for ...
Director, Regulatory Affairs CMC
San Diego, CA · On-site
$189K - $237K/yr
Position Summary Director, Regulatory CMC. Hybrid role (office ~3 days/week) in San Diego, CA; San Francisco, CA; or Princeton, NJ. Primary Responsibilities * Manage CMC regulatory affairs for ...
The Senior Manager, Regulatory Affairs CMC supports the CMC team under the guidance of the Senior Director, CMC. In this role, the Senior Manager provides strategic support and coordination for ...
The Senior Manager, Regulatory Affairs CMC supports the CMC team under the guidance of the Senior Director, CMC. In this role, the Senior Manager provides strategic support and coordination for ...
Senior Director, Regulatory CMC
$260K - $295K/yr
The incumbent will be responsible for overseeing Regulatory CMC aspects of Marea's product development, manufacturing, and eventual commercialization efforts. The position requires a strong ability ...
Senior Director, Regulatory CMC
$260K - $295K/yr
The incumbent will be responsible for overseeing Regulatory CMC aspects of Marea's product development, manufacturing, and eventual commercialization efforts. The position requires a strong ability ...
Senior Director, Regulatory Affairs CMC - Biologics
Boston, MA · Hybrid
$163K - $215K/yr
Job Summary: The Senior Director, Regulatory Affairs CMC - Biologics provides senior-level scientific and strategic regulatory leadership for all Chemistry, Manufacturing, and Controls (CMC ...
Senior Director, Regulatory Affairs CMC - Biologics
Boston, MA · Hybrid
$163K - $215K/yr
Job Summary: The Senior Director, Regulatory Affairs CMC - Biologics provides senior-level scientific and strategic regulatory leadership for all Chemistry, Manufacturing, and Controls (CMC ...
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 ...
Director - CMC Regulatory Affairs (Gene Therapy)
Piscataway, NJ · Remote
$153K - $202K/yr
I am working on Director - CMC Regulatory Affairs position right now. Please send me your updated resume if you have relevant experience and interested in this position. The detailed is as follows ...
Quick apply
Director - CMC Regulatory Affairs (Gene Therapy)
Piscataway, NJ · Remote
$153K - $202K/yr
I am working on Director - CMC Regulatory Affairs position right now. Please send me your updated resume if you have relevant experience and interested in this position. The detailed is as follows ...
Client Direct Client Location Lexington, MA Job Title Senior CMC Regulatory Submission Manager Duration 1 Year+ Must have skill-set [ ] Job Summary Under the direction of the line manager, the CMC ...
Client Direct Client Location Lexington, MA Job Title Senior CMC Regulatory Submission Manager Duration 1 Year+ Must have skill-set [ ] Job Summary Under the direction of the line manager, the CMC ...
Overview The Senior Manager, Regulatory Affairs CMC supports the CMC team under the guidance of the Senior Director, CMC. In this role, the Senior Manager provides strategic support and coordination ...
Overview The Senior Manager, Regulatory Affairs CMC supports the CMC team under the guidance of the Senior Director, CMC. In this role, the Senior Manager provides strategic support and coordination ...
Senior Manager, Global CMC Regulatory Affairs
Chicago, IL · On-site
$155K - $213K/yr
## Senior Manager, Global CMC Regulatory AffairsApplyremote type: Hybridlocations: Chicago, ILtime type: Full timeposted on: Posted 2 Days Agojob requisition id: JR1091** ****Job Purpose**The Senior ...
Senior Manager, Global CMC Regulatory Affairs
Chicago, IL · On-site
$155K - $213K/yr
## Senior Manager, Global CMC Regulatory AffairsApplyremote type: Hybridlocations: Chicago, ILtime type: Full timeposted on: Posted 2 Days Agojob requisition id: JR1091** ****Job Purpose**The Senior ...
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 ...
This role develops and executes CMC regulatory strategies, leads high-quality submissions and health authority interactions, and serves as the primary regulatory CMC advisor to cross-functional teams.
This role develops and executes CMC regulatory strategies, leads high-quality submissions and health authority interactions, and serves as the primary regulatory CMC advisor to cross-functional teams.
This role develops and executes CMC regulatory strategies, leads high-quality submissions and health authority interactions, and serves as the primary regulatory CMC advisor to cross-functional teams.
This role develops and executes CMC regulatory strategies, leads high-quality submissions and health authority interactions, and serves as the primary regulatory CMC advisor to cross-functional teams.
Senior Manager, Global CMC Regulatory Affairs
Chicago, IL · On-site
$155K - $213K/yr
The Senior Manager of CMC Regulatory Affairs represents the function on departmental and cross-functional initiatives. The Senior Manager must be articulate and influence decision-making with key ...
Senior Manager, Global CMC Regulatory Affairs
Chicago, IL · On-site
$155K - $213K/yr
The Senior Manager of CMC Regulatory Affairs represents the function on departmental and cross-functional initiatives. The Senior Manager must be articulate and influence decision-making with key ...
Cmc Regulatory information
See salary details
$19.04 is the 25th percentile. Wages below this are outliers.
$15.63 - $27.45
86% of jobs
$27.45 - $39.27
5% of jobs
$39.27 - $51.09
0% of jobs
$51.09 - $62.92
5% of jobs
$62.92 - $74.74
1% of jobs
$74.74 - $86.56
2% of jobs
$86.56 - $98.38
0% of jobs
$98.38 - $110.21
0% of jobs
$110.21 - $122.03
0% of jobs
$122.03 - $133.85
0% of jobs
$133.85 - $145.67
0% of jobs
$15
$34
$145
How much do cmc regulatory jobs pay per hour?
As of Sep 14, 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?
| Aspect | Cmc 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.
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 are popular job titles for Cmc Regulatory?
Popular job titles for Cmc Regulatory:
- Cmc Regulatory Sciences Specialist
- Director Cmc Regulatory
- Regulatory Cmc Specialist
- Manager Cmc Regulatory Affairs
- Cms Regulatory Management Specialist
- Director Cmc Regulatory Affairs
- Regulatory Affairs Cmc Combination Products
- Regulatory Cmc Manager
- Regulatory Cmc Coordinator
- Cmc Regulatory Affair Specialist
CMC Regulatory Scientist
Rahway, NJ • On-site
WorkLlama, Inc.
• Software Development • 51 - 200 employees51 - 200 employees
Other
Posted 7 days ago
Job description
The Senior Specialist plays a critical role in developing CMC regulatory submission strategies and establishing timelines for assigned pharmaceutical products in accordance with global regulations and guidance. Working independently and collaboratively across cross‑functional teams, this position oversees the preparation, review, and management of regulatory CMC dossiers, renewals, annual reports, variations, and agency responses to gain new registrations and maintain existing commercial products.
Responsibilities- Manage and prepare regulatory CMC dossiers, annual reports, renewals, supplements/variations, and responses to health authority queries to maintain global product registrations.
- Assess post‑approval changes, establish regulatory filing strategies and timelines, identify potential risks, and propose effective mitigation strategies.
- Actively participate on new product development teams and cross‑functional initiatives to deliver all assigned regulatory milestones on a timely basis.
- Maintain comprehensive regulatory data in full compliance with internal processes, procedures, and global standards.
- Continuously build and share expertise on CMC‑related regulations, guidelines (e.g., FDA‑CVM, EMA, VICH), agency expectations, and evolving industry standards.
- Proactively identify and communicate potential regulatory issues to management to ensure timely resolution.
- Execute additional tasks and support ad‑hoc operational initiatives as requested by management.
- Bachelor of Science degree (minimum) in science, engineering, or a related field (advanced degree preferred).
- Minimum of 2 years of relevant experience in pharmaceutical research, manufacturing, or quality assurance.
- Previous experience with Chemistry, Manufacturing, and Controls (CMC) is strongly preferred.
- Proven proficiency in reviewing scientific information and a strong understanding of manufacturing, testing, and quality assurance processes.
- Demonstrated leadership, problem‑solving skills, sound judgment, high attention to detail, and the ability to manage multiple priorities in a fast‑paced environment.
- Strong interpersonal, oral, and written communication skills with professional English proficiency.
- Location: Rahway, NJ.
- Work Model: Hybrid structure requiring 3 days onsite and 2 days working from home (Tuesday and Wednesday serve as mandatory core onsite days).
- Global Regulatory Scope: Applies international regulatory guidelines, including FDA‑CVM, EMA, and VICH, across both new product development and commercial lifecycle management.
About WorkLLama
Sourced by ZipRecruiter
Industry
Software development
Company size
51 - 200 Employees
Headquarters location
Atlanta, GA, US
Year founded
2016