Remote: EST hours Requisition Disclaimer This job posting is for a temporary role with a third ... you direct Atrium to share your application materials, which may include your CV/Resume, email ...
Remote: EST hours Requisition Disclaimer This job posting is for a temporary role with a third ... you direct Atrium to share your application materials, which may include your CV/Resume, email ...
CMC Specialist The CMC Specialist in Regulatory Affairs is responsible for overseeing the Chemistry ... regulations Benefits * Remote working opportunity * Competitive salary, bonus and other benefits
CMC Specialist The CMC Specialist in Regulatory Affairs is responsible for overseeing the Chemistry ... regulations Benefits * Remote working opportunity * Competitive salary, bonus and other benefits
Remote (U.S.-based) with approximately 20-25% travel The Senior Small Molecule Regulatory Affairs ... Assess Chemistry, Manufacturing, and Controls (CMC) strategies for API and drug product programs.
Remote (U.S.-based) with approximately 20-25% travel The Senior Small Molecule Regulatory Affairs ... Assess Chemistry, Manufacturing, and Controls (CMC) strategies for API and drug product programs.
Senior Director, Clinical Regulatory Affairs
Louisville, CO · On-site +1
$156K - $206K/yr
Collaborate closely with translational medicine, preclinical, clinical, CMC Regulatory, and ... Senior Director Level: PhD/MS/BS in a relevant scientific field required with a minimum of 12/15/15 ...
Senior Director, Clinical Regulatory Affairs
Louisville, CO · On-site +1
$156K - $206K/yr
Collaborate closely with translational medicine, preclinical, clinical, CMC Regulatory, and ... Senior Director Level: PhD/MS/BS in a relevant scientific field required with a minimum of 12/15/15 ...
This is a fully remote role, preferably based on the U.S. West Coast, with occasional domestic and ... Review CMC sections of regulatory filings, as needed * Collaborate cross-functionally with CMC ...
This is a fully remote role, preferably based on the U.S. West Coast, with occasional domestic and ... Review CMC sections of regulatory filings, as needed * Collaborate cross-functionally with CMC ...
Director, Regulatory Affairs - Infectious Disease
Berkeley Heights, NJ · On-site +1
$156K - $206K/yr
... remote-based position. Essential Duties * Serve as Regulatory Lead for biologics, focused on ... Develop and execute global regulatory strategies across nonclinical, CMC, and clinical development.
Director, Regulatory Affairs - Infectious Disease
Berkeley Heights, NJ · On-site +1
$156K - $206K/yr
... remote-based position. Essential Duties * Serve as Regulatory Lead for biologics, focused on ... Develop and execute global regulatory strategies across nonclinical, CMC, and clinical development.
Sr. Manager, Regulatory Affairs
San Carlos, CA · On-site +1
$183K - $194K/yr
Executive Director, Regulatory CMC Location: US - Remote Work Arrangement (may be adjusted based on business needs, job responsibilities, or changes to company policy): Remote Compensation: The ...
Sr. Manager, Regulatory Affairs
San Carlos, CA · On-site +1
$183K - $194K/yr
Executive Director, Regulatory CMC Location: US - Remote Work Arrangement (may be adjusted based on business needs, job responsibilities, or changes to company policy): Remote Compensation: The ...
Senior Director/ Director Regulatory Strategy
Boston, MA · On-site +1
$250K - $285K/yr
The Director acts as a strategic partner to R&D, Clinical, Quality, CMC, Commercial, and represents ... Remote role; occasional travel required for regulatory meetings and internal governance forums.
Senior Director/ Director Regulatory Strategy
Boston, MA · On-site +1
$250K - $285K/yr
The Director acts as a strategic partner to R&D, Clinical, Quality, CMC, Commercial, and represents ... Remote role; occasional travel required for regulatory meetings and internal governance forums.
Regulatory Support * Partner with regulatory team to shape CMC strategy for IND submission ... High-impact role with direct access to leadership and decision-making. * Collaborative, mission ...
Regulatory Support * Partner with regulatory team to shape CMC strategy for IND submission ... High-impact role with direct access to leadership and decision-making. * Collaborative, mission ...
... direct impact on the company's path to global development. The ideal candidate brings deep ... Collaborate with CMC and Quality teams to ensure accurate and compliant IMPD and quality ...
... direct impact on the company's path to global development. The ideal candidate brings deep ... Collaborate with CMC and Quality teams to ensure accurate and compliant IMPD and quality ...
Manager, Regulatory Affairs Strategy
San Diego, CA · On-site +1
San Diego, USA- Remote Be a part of a global team that is inspired to make a difference in the ... Partner with Clinical, Nonclinical, CMC, Regulatory Operations, Medical Writing, and Project ...
Manager, Regulatory Affairs Strategy
San Diego, CA · On-site +1
San Diego, USA- Remote Be a part of a global team that is inspired to make a difference in the ... Partner with Clinical, Nonclinical, CMC, Regulatory Operations, Medical Writing, and Project ...
Director, Regulatory Affairs Strategy
San Diego, CA · On-site +1
$159K - $210K/yr
San Diego, USA- Remote Be a part of a global team that is inspired to make a difference in the ... Collaborate with Clinical, Medical, CMC, Nonclinical, and Commercial teams to integrate regulatory ...
Director, Regulatory Affairs Strategy
San Diego, CA · On-site +1
$159K - $210K/yr
San Diego, USA- Remote Be a part of a global team that is inspired to make a difference in the ... Collaborate with Clinical, Medical, CMC, Nonclinical, and Commercial teams to integrate regulatory ...
Regulatory Filings & Health Authority Interactions * Serve as a CMC drug product lead for NDA (and ... Direct involvement in NDA (or equivalent) CMC submissions , including authorship and regulatory ...
Regulatory Filings & Health Authority Interactions * Serve as a CMC drug product lead for NDA (and ... Direct involvement in NDA (or equivalent) CMC submissions , including authorship and regulatory ...
$223K - $234K/yr
Familiarity with utility operations, regulatory context, and the vendors and customers in this ... Remote work and more! About NorthStar: NorthStar Utilities Solutions is a unique company that has ...
New
$223K - $234K/yr
Familiarity with utility operations, regulatory context, and the vendors and customers in this ... Remote work and more! About NorthStar: NorthStar Utilities Solutions is a unique company that has ...
New
Drug CMC Lead
$150K - $215K/yr
This role requires deep expertise in regulatory CMC requirements (especially drug product and formulation development, analytical method development/validation, manufacturing scale-up, and quality ...
Drug CMC Lead
$150K - $215K/yr
This role requires deep expertise in regulatory CMC requirements (especially drug product and formulation development, analytical method development/validation, manufacturing scale-up, and quality ...
Senior Director of Analytical Development
Fort Lauderdale, FL · Remote
$250K - $275K/yr
Regulatory and Compliance Support * Author, review, and approve analytical sections of CMC ... Ability to operate effectively in a remote and virtual work environment. * Demonstrated ability to ...
Quick apply
Senior Director of Analytical Development
Fort Lauderdale, FL · Remote
$250K - $275K/yr
Regulatory and Compliance Support * Author, review, and approve analytical sections of CMC ... Ability to operate effectively in a remote and virtual work environment. * Demonstrated ability to ...
Senior Director of Analytical Development
Fort Lauderdale, FL · On-site +1
$250K - $275K/yr
Regulatory and Compliance Support * Author, review, and approve analytical sections of CMC ... Ability to operate effectively in a remote and virtual work environment. * Demonstrated ability to ...
Senior Director of Analytical Development
Fort Lauderdale, FL · On-site +1
$250K - $275K/yr
Regulatory and Compliance Support * Author, review, and approve analytical sections of CMC ... Ability to operate effectively in a remote and virtual work environment. * Demonstrated ability to ...
(Remote) Director of Product
Oregon, IL · Remote
$218K - $228K/yr
Familiarity with utility operations, regulatory context, and the vendors and customers in this ... Remote work and more! About NorthStar: NorthStar Utilities Solutions is a unique company that has ...
New
(Remote) Director of Product
Oregon, IL · Remote
$218K - $228K/yr
Familiarity with utility operations, regulatory context, and the vendors and customers in this ... Remote work and more! About NorthStar: NorthStar Utilities Solutions is a unique company that has ...
New
Associate Director, Analytical Development and Quality Control
$155K - $190K/yr
The Associate Director, Analytical Development and Quality Control will support analytical ... Author relevant CMC sections to enable global regulatory filings. * Participate on cross-functional ...
Associate Director, Analytical Development and Quality Control
$155K - $190K/yr
The Associate Director, Analytical Development and Quality Control will support analytical ... Author relevant CMC sections to enable global regulatory filings. * Participate on cross-functional ...
$220K - $231K/yr
Familiarity with utility operations, regulatory context, and the vendors and customers in this ... Remote work and more! About NorthStar: NorthStar Utilities Solutions is a unique company that has ...
New
$220K - $231K/yr
Familiarity with utility operations, regulatory context, and the vendors and customers in this ... Remote work and more! About NorthStar: NorthStar Utilities Solutions is a unique company that has ...
New
Remote Director Cmc Regulatory information
See salary details
$91K - $105.3K
1% of jobs
$105.3K - $119.6K
2% of jobs
$119.6K - $134K
10% of jobs
$134K - $148.3K
11% of jobs
$149.2K is the 25th percentile. Wages below this are outliers.
$148.3K - $162.6K
22% of jobs
The median wage is $168K / yr.
$162.6K - $176.9K
13% of jobs
$191K is the 75th percentile. Wages above this are outliers.
$176.9K - $191.2K
17% of jobs
$191.2K - $205.5K
11% of jobs
$205.5K - $219.9K
6% of jobs
$219.9K - $234.2K
4% of jobs
$234.2K - $248.5K
3% of jobs
$91K
$176.2K
$248.5K
How much do remote director cmc regulatory jobs pay per year?
What is the difference between Remote Director Cmc Regulatory vs Remote Cmc Regulatory Manager?
| Aspect | Remote Director Cmc Regulatory | Remote Cmc Regulatory Manager |
|---|---|---|
| Responsibilities | Oversees global CMC regulatory strategies, leads teams, and manages high-level regulatory submissions | Manages daily CMC regulatory activities, supports submission preparation, and ensures compliance |
| Experience & Credentials | Typically requires 10+ years in CMC regulatory roles, advanced degrees, leadership experience | Usually 5-8 years experience, relevant certifications, and strong knowledge of CMC regulations |
| Work Environment | Strategic, leadership-focused, often involved in cross-functional global teams | Operational, project-focused, collaborates with teams on submission activities |
The main difference lies in scope and seniority: the Remote Director Cmc Regulatory holds a strategic leadership role overseeing global CMC regulatory efforts, while the Remote Cmc Regulatory Manager handles more tactical, day-to-day regulatory activities. Both roles require strong CMC regulatory expertise, but the director position involves higher-level decision-making and team management.
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$70/hr
Full-time
Posted 20 days ago
Vertex Pharmaceuticals rating
6.5
Based on 5 frontline employees who took The Breakroom Quiz
78th of 86 rated pharmaceutical
Job description
The Chemistry Manufacturing Controls Manager will be responsible for the detailed planning, preparation and operational execution of a multi-product program in the international region.
This role contributes to the preparation and submission of regulatory CMC documentation and provides regulatory support to various cross functional teams.
Key Duties and Responsibilities
- 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, including creation of content plans and ensuring cross functional alignment
- Reviews CMC sections of regulatory submissions, as well as the interactions and responses with regulatory agencies
- Works with regulatory colleagues in development of global regulatory CMC strategies and Submissions
- Participates effectively in cross-functional teams and may serve as the primary regulatory CMC contact for assigned products and projects
- Supports regulatory assessment and guidance on product compliance topics including change controls, deviations, and GMP investigations
Required Knowledge/Skills
- Strong interpersonal skills to exchange complex information with others and to guide others
- Proficiency in regulatory (FDA, EMA, ICH, international agencies) guidelines
- Strong problem-solving skills and the ability to present the overall assessment for management alignment
- Ability to collaborate and communicate in an open, clear, complete and timely manner
- Strong sense of planning and prioritization, with demonstrated results
Required Education Level & Experience
- Bachelor's degree, with a preference in Biology, Chemistry, Pharmacy, Regulatory Affairs for Drugs, Biologics or Medical Devices, or another related life-science field
- Typically requires 5 years of experience in the pharmaceutical industry or related field
- Experience supporting Small Molecule programs required
Contract length: 12 months with the chance to extend.
Pay Range
$70/hr. - $80/hr.
Shift/Hours
Monday-Friday; Remote: EST hours
Requisition Disclaimer
This job posting is for a temporary role with a third-party agency partner on assignment at Vertex Pharmaceuticals ("Vertex"). The individual selected for this role will be offered the role as an employee of a third- party agency partner; compensation, medical benefits, fringe benefits and other terms and conditions of employment shall be presented by the third-party agency partner upon offer. The pay rate range provided is a reasonable estimate of the anticipated compensation range for this job at the time of posting. The actual pay rate will be based on a number of factors, including skills, competencies, experience, location and/or being pursued and other job-related factors permitted by law. In addition, this role will be eligible for overtime pay, in accordance with federal and state requirements
By applying for this position, you agree to the Atrium Terms and Conditions and you direct Atrium to share your application materials, which may include your CV/Resume, email address or phone number, with Vertex. For more information on how Vertex handles your personal data related to your job application, please see Vertex's Careers Privacy Notice. Agreeing to the Atrium Terms and Conditions, includes permission to use the email address and mobile phone number you provide during the application process or throughout the duration of your prospective or actual employment to notify you of job openings, profiles, articles, news, and other employment-related information, as well as to notify you of special promotions or additional products and services offered by us or our affiliates and partners
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If you do not agree with the Atrium Terms and Conditions, you can still complete your application for this position by emailing your resume to our team at tempstaffing@vrtx.com. Please include the job title in the subject of your email.
No C2C or Third-Party Vendors
What Vertex Pharmaceuticals employees say
Hours and flexibility
Workplace
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About Vertex Pharmaceuticals
Sourced by ZipRecruiter
Industry
Biotechnology research and development
Company size
1,001 - 5,000 Employees
Headquarters location
Boston, MA, US
Year founded
1989