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Regulatory Cmc Program Manager Jobs (NOW HIRING)

Calico

Director, Regulatory CMC

South San Francisco, CA

$275K - $280K/yr

The Director of Regulatory CMC will lead the development and execution of global CMC regulatory ... Manage the lifecycle of the Common Technical Document (CTD) specifically focusing on Module 3 ...

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Regulatory Cmc Program Manager information

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$54.5K

$110.7K

$182K

How much do regulatory cmc program manager jobs pay per year?

As of Sep 13, 2026, the average yearly pay for regulatory cmc program manager in the United States is $110,733.00, according to ZipRecruiter salary data. Most workers in this role earn between $77,500.00 and $136,500.00 per year, depending on experience, location, and employer.

What is the difference between Regulatory Cmc Program Manager vs Regulatory Affairs Specialist?

AspectRegulatory Cmc Program ManagerRegulatory Affairs Specialist
CredentialsBachelor's or Master’s in Life Sciences, Regulatory Affairs certification often preferredBachelor's in Life Sciences, Regulatory Affairs certification common
Work EnvironmentCross-functional teams, project management focusRegulatory submissions, compliance documentation
Industry UsagePharmaceuticals, biotech, biotech manufacturingPharmaceuticals, medical devices, biotech

The Regulatory Cmc Program Manager primarily oversees CMC (Chemistry, Manufacturing, and Controls) aspects of product development, managing projects and timelines. In contrast, the Regulatory Affairs Specialist handles regulatory submissions and compliance documentation across various product areas. Both roles require regulatory knowledge and industry experience but differ in scope and focus.

What are popular job titles related to Regulatory Cmc Program Manager jobs?

For Regulatory Cmc Program Manager jobs, the most frequently searched job titles are:

Infographic showing various Regulatory Cmc Program Manager job openings in the United States as of September 2026, with employment types broken down into 1% Internship, 1% As Needed, 75% Full Time, 20% Part Time, and 3% Contract. Highlights an 94% Physical, 1% Hybrid, and 5% Remote job distribution, with an average salary of $110,733 per year, or $53.2 per hour.

Regulatory CMC Manager - Cell & Gene Therapy (Contract)

Remote

Vertex Pharmaceuticals Incorporated
Biotechnology Research and Development • 1 - 5K employees
Learn more about Vertex Pharmaceuticals Incorporatedexternal

$70/hr

Full-time

Re-posted 21 days ago

Vertex Pharmaceuticals rating

6.5

Company rating: 6.5 out of 10

Based on 5 frontline employees who took The Breakroom Quiz

Job description


The Chemistry Manufacturing Controls Manager will support the execution of cell and gene therapy regulatory CMC strategies for marketed products. This role contributes to the planning, preparation and submission of regulatory CMC documentation. This role also provides regulatory support and guidance to various cross functional teams to ensure all applicable international regulatory requirements are considered and appropriately incorporated into the lifecycle of cell and gene therapy programs.
Key Duties & Responsibilities
  • 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
  • Contributes to the development of global regulatory CMC strategies for commercial products
  • Works with regulatory and technical colleagues to ensure timely submission and approval of CMC changes in the post approval environment
  • Provides regulatory CMC guidance to cross-functional teams and key stakeholders
  • Supports regulatory assessment and guidance on product compliance topics including change controls, deviations, and GMP investigations

Required Education Level & Experience
  • Strong interpersonal skills to exchange complex information with others and to guide others
  • Proficiency in FDA, EMA and international regulatory guidelines
  • Experience in the preparation, reviews and submissions of CMC post approval variations
  • Strong sense of planning, strategic thinking and problem-solving skills
  • Ability to collaborate and communicate in an open, clear, complete, timely and consistent manner
  • Capable of strategic thinking with ability to resolve complex and ambiguous situations
  • Bachelor's degree, with a preference in Biology, Chemistry, Pharmacy, Regulatory Affairs for Drugs, Biologics or Medical Devices, or another related life-science field
  • 5 years of Regulatory CMC experience, including Cell & Gene Therapy Regulatory CMC experience.

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
(collectively, "Atrium Alerts"). Atrium Alerts may be sent by email, phone, or text message. Your personal information will be safely stored within the Atrium & Vertex databases. Atrium does not sell your personal information to third parties. Text message and data rates may apply. To OPT OUT of text messaging or to modify your communication preferences for Atrium Alerts at any time, please contact Atrium at privacyadministrator@atriumstaff.com.
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

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