Provide CMC regulatory guidance to project / product teams. Manage regulatory assessment and guidance on product compliance topics including change controls, deviations, and GMP investigations.
Provide CMC regulatory guidance to project / product teams. Manage regulatory assessment and guidance on product compliance topics including change controls, deviations, and GMP investigations.
... project teams to support the execution of operational activity, monitor adherence to the process ... In addition, the Regulatory Submissions Manager will support the global CMC Regulatory Submissions ...
... project teams to support the execution of operational activity, monitor adherence to the process ... In addition, the Regulatory Submissions Manager will support the global CMC Regulatory Submissions ...
... manage all analytical activities and timelines for Kailera's multiple development projects ... Support analytical CMC activities by tracking and monitoring vendor progress to ensure all work is ...
... manage all analytical activities and timelines for Kailera's multiple development projects ... Support analytical CMC activities by tracking and monitoring vendor progress to ensure all work is ...
Associate II, CMC Operations
Waltham, MA · On-site
... manage all analytical activities and timelines for Kailera's multiple development projects ... Support analytical CMC activities by tracking and monitoring vendor progress to ensure all work is ...
Associate II, CMC Operations
Waltham, MA · On-site
... manage all analytical activities and timelines for Kailera's multiple development projects ... Support analytical CMC activities by tracking and monitoring vendor progress to ensure all work is ...
... PMO to design, implement, and continuously improve CMC digital technology solutions across their full lifecycle Hybrid role based in Cambridge, MA, with 3 days/week onsite. Responsibilities Define ...
... PMO to design, implement, and continuously improve CMC digital technology solutions across their full lifecycle Hybrid role based in Cambridge, MA, with 3 days/week onsite. Responsibilities Define ...
Software-as-a-Service, system integrators), and internal IT teams-including Data/AI, Infrastructure Services, PMO to design, implement, and continuously improve CMC digital technology solutions ...
Software-as-a-Service, system integrators), and internal IT teams-including Data/AI, Infrastructure Services, PMO to design, implement, and continuously improve CMC digital technology solutions ...
Director, Global Regulatory Affairs CMC
Boston, MA · On-site
$163K - $215K/yr
As a GRA CMC member, ensures and / or enhances regulatory compliance ... Ensures project team colleagues, line management, and key stakeholders are apprised of developments ...
Director, Global Regulatory Affairs CMC
Boston, MA · On-site
$163K - $215K/yr
As a GRA CMC member, ensures and / or enhances regulatory compliance ... Ensures project team colleagues, line management, and key stakeholders are apprised of developments ...
CMC Lead, Launch Product, Small Molecules Location: Zurich, Switzerland (Primary) Location ... well as, project management tools. * Scope includes innovation in manufacturing equipment ...
CMC Lead, Launch Product, Small Molecules Location: Zurich, Switzerland (Primary) Location ... well as, project management tools. * Scope includes innovation in manufacturing equipment ...
Senior Director, Drug Product CMC
Boston, MA · On-site
$165K - $250K/yr
Work closely and collaboratively with cross-functional CMC groups including discovery, nonclinical, clinical, project management, legal, sourcing, supply chain, quality and regulatory, as well as ...
Senior Director, Drug Product CMC
Boston, MA · On-site
$165K - $250K/yr
Work closely and collaboratively with cross-functional CMC groups including discovery, nonclinical, clinical, project management, legal, sourcing, supply chain, quality and regulatory, as well as ...
Director, Global Regulatory Affairs CMC
Boston, MA · On-site
$163K - $215K/yr
As a GRA CMC member, ensures and / or enhances regulatory compliance ... Ensures project team colleagues, line management, and key stakeholders are apprised of developments ...
Director, Global Regulatory Affairs CMC
Boston, MA · On-site
$163K - $215K/yr
As a GRA CMC member, ensures and / or enhances regulatory compliance ... Ensures project team colleagues, line management, and key stakeholders are apprised of developments ...
Director, Global Regulatory Affairs CMC
Boston, MA · On-site
$163K - $215K/yr
As a GRA CMC member, ensures and / or enhances regulatory compliance ... Ensures project team colleagues, line management, and key stakeholders are apprised of developments ...
Director, Global Regulatory Affairs CMC
Boston, MA · On-site
$163K - $215K/yr
As a GRA CMC member, ensures and / or enhances regulatory compliance ... Ensures project team colleagues, line management, and key stakeholders are apprised of developments ...
Senior Director, Drug Product CMC
Boston, MA · On-site
$165K - $250K/yr
Work closely and collaboratively with cross-functional CMC groups including discovery, nonclinical, clinical, project management, legal, sourcing, supply chain, quality and regulatory, as well as ...
Senior Director, Drug Product CMC
Boston, MA · On-site
$165K - $250K/yr
Work closely and collaboratively with cross-functional CMC groups including discovery, nonclinical, clinical, project management, legal, sourcing, supply chain, quality and regulatory, as well as ...
RA CMC member on the Global Regulatory CMC team. May serve as or act as the delegate for the GRA ... Ensures project team colleagues, line management, and key stakeholders are apprised of developments ...
RA CMC member on the Global Regulatory CMC team. May serve as or act as the delegate for the GRA ... Ensures project team colleagues, line management, and key stakeholders are apprised of developments ...
VP, CMC
Waltham, MA · On-site
$300K - $340K/yr
... project scope, mitigate risks, and ensure successful delivery with regard to technical quality ... The position requires strategic vision and hands-on experience managing early-stage biotech ...
VP, CMC
Waltham, MA · On-site
$300K - $340K/yr
... project scope, mitigate risks, and ensure successful delivery with regard to technical quality ... The position requires strategic vision and hands-on experience managing early-stage biotech ...
RA CMC member on the Global Regulatory CMC team. May serve as or act as the delegate for the GRA ... Ensures project team colleagues, line management, and key stakeholders are apprised of developments ...
RA CMC member on the Global Regulatory CMC team. May serve as or act as the delegate for the GRA ... Ensures project team colleagues, line management, and key stakeholders are apprised of developments ...
Associate Director, CMC Lead
Boston, MA · On-site
$136K - $204K/yr
Manage multiple early-stage programs; set priorities, balance resources, and adjust strategies as data emerge to protect the critical path. Cross-Functional Influence: Represent CMC on project teams ...
Associate Director, CMC Lead
Boston, MA · On-site
$136K - $204K/yr
Manage multiple early-stage programs; set priorities, balance resources, and adjust strategies as data emerge to protect the critical path. Cross-Functional Influence: Represent CMC on project teams ...
Associate Director, CMC Lead
Boston, MA · On-site
$136K - $204K/yr
Manage multiple early-stage programs; set priorities, balance resources, and adjust strategies as data emerge to protect the critical path. * Cross-Functional Influence: Represent CMC on project ...
Associate Director, CMC Lead
Boston, MA · On-site
$136K - $204K/yr
Manage multiple early-stage programs; set priorities, balance resources, and adjust strategies as data emerge to protect the critical path. * Cross-Functional Influence: Represent CMC on project ...
Associate II, CMC Operations
Waltham, MA · On-site
$78K - $95K/yr
... CMC sub-teams to ... manage all analytical activities and timelines for Kailera's multiple development projects.
Associate II, CMC Operations
Waltham, MA · On-site
$78K - $95K/yr
... CMC sub-teams to ... manage all analytical activities and timelines for Kailera's multiple development projects.
Associate Director, CMC Lead
Boston, MA · On-site
$136K - $204K/yr
Manage multiple early-stage programs; set priorities, balance resources, and adjust strategies as data emerge to protect the critical path. * Cross-Functional Influence: Represent CMC on project ...
Associate Director, CMC Lead
Boston, MA · On-site
$136K - $204K/yr
Manage multiple early-stage programs; set priorities, balance resources, and adjust strategies as data emerge to protect the critical path. * Cross-Functional Influence: Represent CMC on project ...
Director or Senior Director, Regulatory CMC
Watertown, MA · On-site
$195K - $330K/yr
Serve as the regulatory CMC lead for multiple programs, partnering closely with CMC, Quality, Non ... Strong organizational and project management skills, with the ability to manage multiple programs ...
Director or Senior Director, Regulatory CMC
Watertown, MA · On-site
$195K - $330K/yr
Serve as the regulatory CMC lead for multiple programs, partnering closely with CMC, Quality, Non ... Strong organizational and project management skills, with the ability to manage multiple programs ...
Cmc Project Manager information
See Andover, MA salary details
$45.6K - $57K
15% of jobs
$57K - $68.5K
2% of jobs
$68.5K - $80K
4% of jobs
$82.7K is the 25th percentile. Wages below this are outliers.
$80K - $91.4K
18% of jobs
The median wage is $99.3K / yr.
$91.4K - $102.9K
17% of jobs
$102.9K - $114.4K
11% of jobs
$123.5K is the 75th percentile. Wages above this are outliers.
$114.4K - $125.8K
10% of jobs
$125.8K - $137.3K
8% of jobs
$137.3K - $148.8K
6% of jobs
$148.8K - $160.2K
4% of jobs
$160.2K - $171.7K
4% of jobs
$45.6K
$106.4K
$171.7K
How much do cmc project manager jobs pay per year?
What is a CMC Project Manager?
A CMC (Chemistry, Manufacturing, and Controls) Project Manager oversees the development, manufacturing, and regulatory aspects of pharmaceutical products. They coordinate cross-functional teams, manage timelines, and ensure compliance with regulatory requirements. Their role is critical in guiding drug development from early stages to commercialization while maintaining quality and efficiency.
What are the typical responsibilities of a CMC Project Manager in a pharmaceutical company?
A CMC Project Manager is responsible for coordinating cross-functional teams to ensure successful delivery of project milestones related to product development, manufacturing, and regulatory submissions. Their daily tasks often include developing project timelines, managing risk assessments, overseeing documentation, and facilitating communication between technical, regulatory, and quality departments. They play a pivotal role in preparing CMC sections for regulatory filings, supporting process optimization, and troubleshooting manufacturing challenges. This position requires excellent multitasking abilities and close collaboration with internal stakeholders and external partners throughout the product lifecycle.
What are the key skills and qualifications needed to thrive as a CMC Project Manager, and why are they important?
A CMC Project Manager needs strong expertise in Chemistry, Manufacturing, and Controls (CMC) processes, project management certifications (such as PMP), and a background in pharmaceutical or biotech industries. Familiarity with regulatory submission systems, quality management software, and documentation tools is highly valued. Exceptional organizational skills, problem-solving ability, and effective cross-functional communication help candidates excel in this role. These capabilities are critical for ensuring project milestones are met, regulatory requirements are satisfied, and product development remains on track.
What are popular job titles related to Cmc Project Manager jobs in Andover, MA?
For Cmc Project Manager jobs in Andover, MA, the most frequently searched job titles are:
What job categories do people searching Cmc Project Manager jobs in Andover, MA look for?
The top searched job categories for Cmc Project Manager jobs in Andover, MA are:
What cities near Andover, MA are hiring for Cmc Project Manager jobs?
Cities near Andover, MA with the most Cmc Project Manager job openings:

Contractor
Re-posted 7 days ago
Job 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.
Client: Direct Client
Location: Lexington, MA
Job Title: Global Regulatory Affairs (CMC) Manager
Duration: 5 Months + (Possible Extension)
SummaryÂ
Under the direction of the Director of Regulatory Affairs direct and manage Regulatory Affairs activities for developing global CMC strategies across product life cycles & execution in North America. Provide collaborative support for execution of global strategies to other regions (EU & International). Manage submissions and interactions with the FDA and Health Canada for CMC issues. Provide support to other HA interactions as required.Â
Job Function and Description:Â
Provide regulatory support, guidance and expertise to internal groups such as product development, QA, QC and manufacturing teams to ensure that all applicable regulatory requirements are considered and appropriately incorporated into development programs and that products are developed and manufactured in compliance with appropriate regulations and guidelines so that they be studied and marketed as planned.Â
Manage preparation of US and Canada applications in a timely manner to meet corporate objectives.Â
Collaborate with EU & International regulatory colleagues to ensure global perspective and provide support in the preparation of EU and International regulatory documentation in a timely manner to meet corporate objectives.Â
Develop global CMC regulatory strategy and manage regulatory activities and timelines for one or more investigational and marketed productsÂ
Collaborate with EU & International regulatory colleagues in development of global CMC regulatory strategies.Â
Lead the preparation and filing of CMC sections of regulatory submissions and interactions with regulatory agencies.Â
Review and approve technical documentation including technology transfer protocols, validation protocols, technical reports, manufacturing and labeling information to assure conformance with regulations; and regulatory guidelines.
Provide CMC regulatory guidance to project / product teams.Â
Manage regulatory assessment and guidance on product compliance topics including change controls, deviations, and GMP investigations.
Education & Experience:
B.A. / B.A./ M.S. / Ph.D. in biochemistry, chemistry, biology or related pharmaceutical field. Minimum of 4 years experience in pharmaceutical product development including significant experience in CMC regulatory affairs with a strong biologics background or equivalent.Â
Experience in directing interactions with regulatory authorities desired.
Knowledgeable in ICH and FDA guidelines relevant to CMC aspects of product development and maintenance.Â
Significant coordination with cross-functional teams internally and regulatory authorities externally.Â
Thanks!!!
Warm Regards,
Amrit Singh
Clinical Recruiter
Integrated Resources, Inc.
IT REHAB CLINICAL NURSING
Tel: (732) 429 1634 (Direct)
Ext: (732) 549 2030 x (212)Â
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
https://www.linkedin.com/company/46970?trk=prof-exp-company-name
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