Manager, Regulatory Affairs- CMC
$127K - $190K/yr
Manages CMC development and post marketing projects. Execution of Strategy and Submissions: Prepares content templates and supports the technical team in preparation of submission documents for ...
$127K - $190K/yr
Manages CMC development and post marketing projects. Execution of Strategy and Submissions: Prepares content templates and supports the technical team in preparation of submission documents for ...
$127K - $190K/yr
Manages CMC development and post marketing projects. Execution of Strategy and Submissions: Prepares content templates and supports the technical team in preparation of submission documents for ...
Cambridge, MA · On-site
$119K - $162K/yr
Manage the CMC FP&A planning cycles and variance analysis. * Serve as the primary point of contact for Corporate FP&A on CMC results, forecast updates, and key business drivers. * Develop planning ...
Cambridge, MA · On-site
$119K - $162K/yr
Manage the CMC FP&A planning cycles and variance analysis. * Serve as the primary point of contact for Corporate FP&A on CMC results, forecast updates, and key business drivers. * Develop planning ...
South San Francisco, CA · On-site
$140K - $150K/yr
Project Manager (CMC / Development Operations) Location: South San Francisco, CA Remote, Hybrid and In Person options Opportunity: Epicrispr Biotechnologies is seeking a highly organized and ...
South San Francisco, CA · On-site
$140K - $150K/yr
Project Manager (CMC / Development Operations) Location: South San Francisco, CA Remote, Hybrid and In Person options Opportunity: Epicrispr Biotechnologies is seeking a highly organized and ...
El Segundo, CA · On-site
$200K - $230K/yr
Reporting to the VP, Pharma Program Management), this position requires collaboration across ... Develop and lead all GMP CMC-related activities (biologics and small molecule) including process ...
El Segundo, CA · On-site
$200K - $230K/yr
Reporting to the VP, Pharma Program Management), this position requires collaboration across ... Develop and lead all GMP CMC-related activities (biologics and small molecule) including process ...
With some supervision, plans, executes and manages regulatory submissions according to the regulatory strategy laid out by the GRA CMC Product/Device lead(s) * Independently defines CMC content (data ...
With some supervision, plans, executes and manages regulatory submissions according to the regulatory strategy laid out by the GRA CMC Product/Device lead(s) * Independently defines CMC content (data ...
As a RA CMC member, ensures and/or enhances regulatory compliance. * Ensures project team colleagues, line management, and key stakeholders are apprised of developments that may impact regulatory ...
As a RA CMC member, ensures and/or enhances regulatory compliance. * Ensures project team colleagues, line management, and key stakeholders are apprised of developments that may impact regulatory ...
The Position The Sr Manager Regulatory CMC ensures efficient and compliant management of regulatory change control and post-approval activities. Supporting diverse modalities-including small ...
The Position The Sr Manager Regulatory CMC ensures efficient and compliant management of regulatory change control and post-approval activities. Supporting diverse modalities-including small ...
The Position The Sr Manager Regulatory CMC ensures efficient and compliant management of regulatory change control and post-approval activities. Supporting diverse modalities--including small ...
Quick apply
The Position The Sr Manager Regulatory CMC ensures efficient and compliant management of regulatory change control and post-approval activities. Supporting diverse modalities--including small ...
$153K - $202K/yr
Manage scope of work, budget, and timelines for external vendors, including consultants and external CMC writers * Participate in business development activities, including assisting in the ...
$153K - $202K/yr
Manage scope of work, budget, and timelines for external vendors, including consultants and external CMC writers * Participate in business development activities, including assisting in the ...
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
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
$145K - $160K/yr
Senior Manager, CMC Analytical Sciences Reports to: Director, Chemistry, Manufacturing & Controls (CMC) Analytical Sciences Location: Remote Worker, US Only Why Sabin: Our mission is to make vaccines ...
$145K - $160K/yr
Senior Manager, CMC Analytical Sciences Reports to: Director, Chemistry, Manufacturing & Controls (CMC) Analytical Sciences Location: Remote Worker, US Only Why Sabin: Our mission is to make vaccines ...
San Francisco, CA · On-site
$176K - $233K/yr
Job Title: Director, Regulatory CMC Location: San Francisco, CA (Onsite - 4 days/week) Industry ... Excellent communication, leadership, and stakeholder management skills
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San Francisco, CA · On-site
$176K - $233K/yr
Job Title: Director, Regulatory CMC Location: San Francisco, CA (Onsite - 4 days/week) Industry ... Excellent communication, leadership, and stakeholder management skills
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 ...
New
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 ...
New
South San Francisco, CA · Remote
$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 ...
New
Quick apply
South San Francisco, CA · Remote
$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 ...
New
Foster City, CA · On-site
$157K - $203K/yr
As a Senior Manager, CMC Regulatory Affairs for Biologics, at Gilead you will be responsible for the regulatory strategy for one or more molecules in the Biologics portfolio. This position will ...
Foster City, CA · On-site
$157K - $203K/yr
As a Senior Manager, CMC Regulatory Affairs for Biologics, at Gilead you will be responsible for the regulatory strategy for one or more molecules in the Biologics portfolio. This position will ...
$125K - $145K/yr
About the role The Manager, Regulatory Affairs will support the development and execution of regulatory strategies for assigned programs, with a balanced focus on CMC and Clinical Regulatory Affairs.
$125K - $145K/yr
About the role The Manager, Regulatory Affairs will support the development and execution of regulatory strategies for assigned programs, with a balanced focus on CMC and Clinical Regulatory Affairs.
El Segundo, CA · On-site
$200K - $230K/yr
Reporting to the VP, Pharma Program Management), this position requires collaboration across ... Develop and lead all GMP CMC-related activities (biologics and small molecule) including process ...
El Segundo, CA · On-site
$200K - $230K/yr
Reporting to the VP, Pharma Program Management), this position requires collaboration across ... Develop and lead all GMP CMC-related activities (biologics and small molecule) including process ...
Gaithersburg, MD · On-site
$162K - $213K/yr
Manages all aspects of regulatory CMC activities, assists in the development of regulatory submission timelines, and ensures execution to meet corporate goals * Responsible for the preparation of all ...
Gaithersburg, MD · On-site
$162K - $213K/yr
Manages all aspects of regulatory CMC activities, assists in the development of regulatory submission timelines, and ensures execution to meet corporate goals * Responsible for the preparation of all ...
$145K - $207K/yr
You will lead and manage CMC-regulatory assessment and guidance on product compliance topics, including change controls, deviations, and GMP investigations, in conjunction and consultation with CMC ...
$145K - $207K/yr
You will lead and manage CMC-regulatory assessment and guidance on product compliance topics, including change controls, deviations, and GMP investigations, in conjunction and consultation with 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 ...
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 ...
$23K - $30.2K
4% of jobs
$30.2K - $37.5K
10% of jobs
$43.3K is the 25th percentile. Wages below this are outliers.
$37.5K - $44.7K
14% of jobs
$44.7K - $51.9K
16% of jobs
The median wage is $58.1K / yr.
$51.9K - $59.1K
7% of jobs
$59.1K - $66.4K
10% of jobs
$70K is the 75th percentile. Wages above this are outliers.
$66.4K - $73.6K
29% of jobs
$73.6K - $80.8K
4% of jobs
$80.8K - $88K
3% of jobs
$88K - $95.3K
1% of jobs
$95.3K - $102.5K
2% of jobs
$23K
$61.4K
$102.5K
| Aspect | Cmc Manager | Cmc Specialist |
|---|---|---|
| Credentials | Bachelor's or Master's in Life Sciences, Chemistry, or related field; often requires industry certifications | Similar educational background; certifications may enhance prospects |
| Work Environment | Oversees teams, manages projects, liaises with regulatory agencies | Executes specific tasks within projects, supports Cmc managers |
| Responsibilities | Strategic planning, team leadership, regulatory submissions | Data compilation, documentation, technical support |
The Cmc Manager typically holds a leadership role, overseeing Cmc specialists and managing regulatory processes, while the Cmc Specialist focuses on technical execution and documentation. Both roles require similar educational backgrounds and industry experience, but differ mainly in scope and responsibility.

$127K - $190K/yr
Other
Posted 17 days ago
Job Summary This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub team and the broader RA team. This position manages assigned developmental and post marketing projects with a high level of supervision. This position prepares content templates and supports the technical team in the preparation of submission documents (e.g., IND, BLA, IB, NDA, Amendments, Supplements, Briefing Books) for review by higher-level manager.
This position demonstrates understanding of key regulatory guidances and their application during the development process. This position works with problems that are typically simple, straightforward and task driven. This position has a high level of supervision and is supportive in nature.
Responsibilities Planning for Development and Post Marketing Projects: Manages CMC development and post marketing projects. Execution of Strategy and Submissions: Prepares content templates and supports the technical team in preparation of submission documents for review by higher-level manager. FDA Interactions: Leads FDA interactions with high level of supervision.
Regulatory Knowledge: Demonstrates understanding of key US regulatory guidances and their application during the development process. Qualifications Education Qualifications Bachelor's Degree in a scientific discipline required Master's Degree in a scientific discipline preferred Experience Qualifications 5-8 years of pharmaceutical industry experience with 2+ years of direct or related CMC regulatory experience preferred Travel Requirements Ability to travel up to 5% of the time. Daiichi Sankyo, Inc.
is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law. Salary Range: USD$127,280.00 - USD$190,920.00 Download Our Benefits Summary PDF