Client Direct Client Location Lexington, MA Job Title Senior CMC Regulatory Submission Manager ... Maintains operational excellence of the process. Oversees management of the content planning of ...
Client Direct Client Location Lexington, MA Job Title Senior CMC Regulatory Submission Manager ... Maintains operational excellence of the process. Oversees management of the content planning of ...
The role provides strategic and operational support for the preparation, review, and submission of ... Lead post-approval CMC regulatory lifecycle management activities, including strategy development ...
The role provides strategic and operational support for the preparation, review, and submission of ... Lead post-approval CMC regulatory lifecycle management activities, including strategy development ...
The role provides strategic and operational support for the preparation, review, and submission of ... Lead post-approval CMC regulatory lifecycle management activities, including strategy development ...
The role provides strategic and operational support for the preparation, review, and submission of ... Lead post-approval CMC regulatory lifecycle management activities, including strategy development ...
Software Developer Strategy CMC
Los Alamos, NM · On-site
$75 - $85/hr
Develop operational procedures, documentation, and best practices for long-term support * Mentor ... Ability to work independently while collaborating with technical and management stakeholders ...
Software Developer Strategy CMC
Los Alamos, NM · On-site
$75 - $85/hr
Develop operational procedures, documentation, and best practices for long-term support * Mentor ... Ability to work independently while collaborating with technical and management stakeholders ...
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 ... Acts as liaison between Global Health Operations and R&D functions as single point of contact for ...
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 ... Acts as liaison between Global Health Operations and R&D functions as single point of contact for ...
The Role Reporting to the Executive Director of Digital Operations and Strategic Portfolio Management, the Director, CMC Digital Operations and Strategic Portfolio Management will own and drive a ...
The Role Reporting to the Executive Director of Digital Operations and Strategic Portfolio Management, the Director, CMC Digital Operations and Strategic Portfolio Management will own and drive a ...
The Senior Manager, CMC Regulatory Affairs is responsible for providing strategic and operational regulatory leadership for Chemistry, Manufacturing, and Controls (CMC) activities across development ...
The Senior Manager, CMC Regulatory Affairs is responsible for providing strategic and operational regulatory leadership for Chemistry, Manufacturing, and Controls (CMC) activities across development ...
Senior Manager, Global Regulatory Affairs CMC
Billerica, MA · On-site
$150 - $200/hr
Your Role The Senior Manager Regulatory CMC (RCMC) is responsible and accountable for driving all ... Acts as liaison between Global Health Operations and R&D functions as single point of contact for ...
Senior Manager, Global Regulatory Affairs CMC
Billerica, MA · On-site
$150 - $200/hr
Your Role The Senior Manager Regulatory CMC (RCMC) is responsible and accountable for driving all ... Acts as liaison between Global Health Operations and R&D functions as single point of contact for ...
The Senior Manager, CMC Regulatory Affairs is responsible for providing strategic and operational regulatory leadership for Chemistry, Manufacturing, and Controls (CMC) activities across development ...
The Senior Manager, CMC Regulatory Affairs is responsible for providing strategic and operational regulatory leadership for Chemistry, Manufacturing, and Controls (CMC) activities across development ...
The Senior Manager, CMC Regulatory Affairs is responsible for providing strategic and operational regulatory leadership for Chemistry, Manufacturing, and Controls (CMC) activities across development ...
The Senior Manager, CMC Regulatory Affairs is responsible for providing strategic and operational regulatory leadership for Chemistry, Manufacturing, and Controls (CMC) activities across development ...
The Role Reporting to the Executive Director of Digital Operations and Strategic Portfolio Management, the Director, CMC Digital Operations and Strategic Portfolio Management will own and drive a ...
The Role Reporting to the Executive Director of Digital Operations and Strategic Portfolio Management, the Director, CMC Digital Operations and Strategic Portfolio Management will own and drive a ...
This role will manage regulatory CMC aspects of compounds (large molecules) through all phases of development and provide strategic and operational management of preparation and maintenance of CMC ...
This role will manage regulatory CMC aspects of compounds (large molecules) through all phases of development and provide strategic and operational management of preparation and maintenance of CMC ...
Manager, Quality Operations, CMC
$117K - $137K/yr
The Opportunity The Manager, Quality Operations, CMC is a key quality partner responsible for ensuring that Praxis medicines are manufactured, tested, controlled, released, and maintained to the ...
Manager, Quality Operations, CMC
$117K - $137K/yr
The Opportunity The Manager, Quality Operations, CMC is a key quality partner responsible for ensuring that Praxis medicines are manufactured, tested, controlled, released, and maintained to the ...
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 ... Acts as liaison between Global Health Operations and R&D functions as single point of contact for ...
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 ... Acts as liaison between Global Health Operations and R&D functions as single point of contact for ...
Senior Manager, CMC Project Management
South San Francisco, CA · On-site
$150K - $170K/yr
The Senior Manager will partner closely with functional leaders across Operations Technology ... This role requires a strong foundation in project management with an emphasis on CMC knowledge and ...
Senior Manager, CMC Project Management
South San Francisco, CA · On-site
$150K - $170K/yr
The Senior Manager will partner closely with functional leaders across Operations Technology ... This role requires a strong foundation in project management with an emphasis on CMC knowledge and ...
The Opportunity Amylyx is seeking an experienced Associate Director, CMC Program Management to provide strategic and operational program management leadership across our CMC portfolio. This ...
The Opportunity Amylyx is seeking an experienced Associate Director, CMC Program Management to provide strategic and operational program management leadership across our CMC portfolio. This ...
Director, Regulatory CMC
Somerville, MA · Hybrid
$163K - $216K/yr
The Director partners closely with Technical Operations, Quality, and Supply Chain to ensure ... Manage regulatory CMC activities supporting commercial manufacturing, supply continuity, and ...
Director, Regulatory CMC
Somerville, MA · Hybrid
$163K - $216K/yr
The Director partners closely with Technical Operations, Quality, and Supply Chain to ensure ... Manage regulatory CMC activities supporting commercial manufacturing, supply continuity, and ...
The Senior Manager, CMC Regulatory Affairs is responsible for providing strategic and operational regulatory leadership for Chemistry, Manufacturing, and Controls (CMC) activities across development ...
The Senior Manager, CMC Regulatory Affairs is responsible for providing strategic and operational regulatory leadership for Chemistry, Manufacturing, and Controls (CMC) activities across development ...
Senior Manager, Regulatory Affairs CMC
Wilmington, DE · On-site
$150 - $200/hr
... operations in North America, Europe, and Asia. Job Summary (Primary function) This role will primarily be responsible for managing regulatory CMC submissions and strategy for Incyte development and ...
Senior Manager, Regulatory Affairs CMC
Wilmington, DE · On-site
$150 - $200/hr
... operations in North America, Europe, and Asia. Job Summary (Primary function) This role will primarily be responsible for managing regulatory CMC submissions and strategy for Incyte development and ...
The Senior Manager, CMC Regulatory Affairs is responsible for providing strategic and operational regulatory leadership for Chemistry, Manufacturing, and Controls (CMC) activities across development ...
The Senior Manager, CMC Regulatory Affairs is responsible for providing strategic and operational regulatory leadership for Chemistry, Manufacturing, and Controls (CMC) activities across development ...
Cmc Operation Manager information
See salary details
$13.94 - $16.11
8% of jobs
$17.20 is the 25th percentile. Wages below this are outliers.
$16.11 - $18.27
33% of jobs
The median wage is $18.83 / hr.
$18.27 - $20.43
35% of jobs
$20.43 - $22.60
3% of jobs
$22.60 - $24.76
1% of jobs
$24.76 - $26.92
3% of jobs
$26.92 - $29.09
5% of jobs
$29.09 - $31.25
4% of jobs
$31.25 - $33.41
4% of jobs
$33.41 - $35.58
2% of jobs
$35.58 - $37.74
1% of jobs
$13
$22
$37
How much do cmc operation manager jobs pay per hour?
As of Sep 9, 2026, the average hourly pay for cmc operation manager in the United States is $22.24, according to ZipRecruiter salary data. Most workers in this role earn between $17.07 and $24.28 per hour, depending on experience, location, and employer.
What states have the most Cmc Operation Manager jobs?
States with the most job openings for Cmc Operation Manager jobs include:
What are popular job titles related to Cmc Operation Manager jobs?
For Cmc Operation Manager jobs, the most frequently searched job titles are:
Senior CMC Regulatory Submission Manager
Lexington, MA • On-site
Integrated Resources INC •
Recruiting and Staffing Services • 51 - 200 employees51 - 200 employees
Contractor
Re-posted 14 days ago
Job description
Company Description
A Few Words About Us - Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing.
Job Description
Position Details:
Client Direct Client
Location Lexington, MA
Job Title Senior CMC Regulatory Submission Manager
Duration 1 Year+
Must have skill-set [Job Description] Job Summary
Under the direction of the line manager, the CMC Regulatory Submissions Manager supports the management and oversight of the CMC Regulatory Submissions for Global Portafolio of early development programs (IMPD/CTA/IND). The Regulatory Submissions Manager is also responsible for execution of the global CMC submission process (Creation, Review, Approval, Submission and Commercial Implementation of CMC Dossiers for Marketing Applications and Post- Approval) by working closely with Product Development, Regulatory, QA, GPT and MS&T crossfunctional project teams to support the execution of operational activity, monitor adherence to the process, periodically evaluate the metrics, revise the process as required, implement changes and provide appropriate training and tools. The manager will be responsible for tracking global submission activities for Biologics and Chemically Synthesized Products. In addition, the Regulatory Submissions Manager will support the global CMC Regulatory Submissions and Document Compliance department with expertise in general pharmaceutical development of global products, submission ready standards and eCTD requirements
Responsibilities:
Knowledge of global CMC regulatory submission requirements
including submission formats (eCTD for IND, IMPD, NDA, MAAs and NEES).
Department lead on the clinical and commercial CMC submission
processes.
Tracking global submission activities. Oversees regulatory
submissions trackers
Supports the monitoring of global CMC process, evaluation of metrics periodically, monitoring the process, supports changes and provides training and tools. Maintains operational excellence of the process.
Oversees management of the content planning of regulatory
submissions within PD.
Provides guidance for submission eCTD granularity.
Maintains oversight and executes documents to submission ready
standard for CMC regulatory submissions.
Maintains global module 3 templates.
Oversees management of Quality 3D domain: Quality Folder, PD file guide, Annex 3, Submission ready standards guide.
Maintains awareness of current trends in regulatory requirements
through literature searches and networking.
Basic knowledge of US, Canadian, European regulatory requirements for APls and drug products for biologics and chemically synthesized.
Qualifications
Qualifications:
Bachelor's degree (or higher) in Chemistry, Pharmacy, Pharmaceutics, Chemical Engineering, or closely related field is desirable.
Minimum 5 years of experience in the Pharmaceutical Industry is required.
Familiarity with pharmaceutical product development, regulatory guidelines and experience in regulatory submissions (in particular CMC Module 3 information and QOS documents) throught out the development lifecycle is highly desirable.
Experience in working with the outsourcing model is preferre
Additional Information
Feel free to forward my email to your friends/colleagues who might be available
Thanks!!!
Warm Regards,
Amrit Singh
Clinical Recruiter
Integrated Resources, Inc
IT REHAB CLINICAL NURSING
Tel: (732) 429 1634
Fax: (732) 549 5549
http://www.irionline.com
Inc. 5000 - 2007, 2008, 2009, 2010, 2011, 2012,2013 & 2014 (8th Year)
Certified MBE I GSA - Schedule 66 I GSA - Schedule 621I I GSA - Schedule 70
About Integrated Resources
Sourced by ZipRecruiter
Integrated Resources Inc (IRI), based in Edison, NJ, US, is an esteemed player in the staffing solutions industry with a credible presence on their official website irionline.com. Notably, IRI provides a range of professional staffing services including contract, contract-to-hire, and direct hire solutions to a wide spectrum of industries such as healthcare, life sciences, manufacturing, financial, insurance, and others. Since its inception, IRI has been committed to delivering top-talent and optimum solutions to meet its clients' diverse needs.
Industry
Recruiting and staffing services
Company size
51 - 200 Employees
Headquarters location
Edison, NJ, US
Year founded
1996