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Cmc Jobs (NOW HIRING)

Gilead

Manager, Regulatory Affairs CMC

Foster City, CA · On-site

$146K - $189K/yr

The CMC Regulatory Affairs Manager is responsible forsupporting the planning, coordination, and execution of CMC regulatory activities across global clinical and commercial programs. This role ...

taiho

Director, Regulatory Affairs CMC

Princeton, NJ · Hybrid

$157K - $207K/yr

Your expertise will play a pivotal and visible role in advancing CMC strategy and submissions of developmental, life cycle and post approval projects in US, EU, Canada and more, working with ...

Allucent

Sr. Director, CMC

Cary, NC · Remote

As a Sr. Director, CMC at Allucent, you are responsible for assisting clients with Chemistry Manufacturing and Control (CMC) and related pharmaceutical development activities of drug, biologic or ...

BeiGene, Inc.

Executive Director, Regulatory Affairs, CMC

$153K - $202K/yr

Biologics Regulatory CMC organization. This role provides strategic and operational leadership for U.S.-based biologics Regulatory CMC activities and serves as a key partner to the China-based ...

Revolution Medicines

Director, Global CMC Regulatory

$153K - $202K/yr

The Director, Global CMC Regulatory is a strategic leadership role responsible for developing, driving, and executing global commercial CMC regulatory strategies to secure and maintain marketing ...

Opus Regulatory

Principal Consultant, CMC

Miami, FL · On-site

Regulatory Strategy, CMC, Labeling, Ad Promo, Medical Review, and Medical Information. Our team of senior-level leaders and innovators provides project-specific contributions or ongoing support ...

Takeda

Director, Global Regulatory Affairs CMC

Boston, MA · On-site

$163K - $215K/yr

Independently develops the regulatory CMC strategy and leads the execution of regulatory CMC investigational, registration and post-approval strategies for their assigned product(s) as the GRA CMC ...

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Cmc information

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$13

$31

$67

How much do cmc jobs pay per hour?

As of Jun 22, 2026, the average hourly pay for cmc in the United States is $31.24, according to ZipRecruiter salary data. Most workers in this role earn between $19.23 and $36.54 per hour, depending on experience, location, and employer.

What are the key skills and qualifications needed to thrive as a CMC (Chemistry, Manufacturing, and Controls) professional, and why are they important?

To thrive as a CMC professional, you need expertise in pharmaceutical sciences, regulatory requirements, and process development, typically supported by a degree in chemistry, pharmacy, or a related field. Familiarity with regulatory submission systems, analytical tools, and quality management software is essential. Strong project management, attention to detail, and effective communication are vital soft skills for coordinating cross-functional teams and ensuring compliance. These skills and qualities are critical to guarantee the safety, efficacy, and regulatory approval of pharmaceutical products.

What are some common challenges faced by a CMC professional when coordinating between R&D, manufacturing, and regulatory teams?

CMC professionals often encounter challenges in aligning the timelines and priorities of R&D, manufacturing, and regulatory teams. Ensuring that product development meets both regulatory requirements and manufacturing feasibility can require extensive cross-functional communication and problem-solving. Additionally, adapting to evolving regulatory guidelines and integrating feedback from multiple stakeholders demands strong project management skills. Overcoming these challenges is essential for maintaining project momentum and ensuring successful product submissions.

What are CMC professionals?

CMC stands for Chemistry, Manufacturing, and Controls. CMC professionals are responsible for ensuring that pharmaceutical products are developed, manufactured, and controlled in compliance with regulatory standards. Their work includes overseeing formulation development, analytical testing, process validation, and documentation required for regulatory submissions. CMC experts play a critical role in bringing safe and effective drugs to market by ensuring product quality and consistency throughout the development and manufacturing process.

What is the difference between CMC vs Regulatory Affairs Specialist?

AspectCMCRegulatory Affairs Specialist
Required CredentialsBachelor's degree in life sciences, chemistry, or pharmacy; often additional certifications in pharmaceutical sciencesBachelor's degree in life sciences, pharmacy, or related field; certifications in regulatory affairs are common
Work EnvironmentLaboratories, manufacturing sites, and R&D departments within pharmaceutical companiesRegulatory agencies, pharmaceutical companies, and consulting firms
Industry UsageFocuses on drug development, manufacturing, and quality documentationFocuses on compliance, submissions, and communication with regulatory bodies

While both CMC and Regulatory Affairs Specialists work within the pharmaceutical industry, CMC professionals primarily handle the chemistry, manufacturing, and control aspects of drug development. Regulatory Affairs Specialists focus on ensuring compliance with regulations and managing submissions to authorities. Both roles often collaborate but serve distinct functions in bringing a drug to market.

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Cmc jobs near you
Infographic showing various Cmc job openings in the United States as of June 2026, with employment types broken down into 1% As Needed, 83% Full Time, 14% Part Time, and 2% Contract. Highlights an 92% Physical, 3% Hybrid, and 5% Remote job distribution, with an average salary of $64,986 per year, or $31.2 per hour.
Manager, Regulatory Affairs CMC

Manager, Regulatory Affairs CMC

Gilead

Foster City, CA • On-site

$146K - $189K/yr

Full-time

Medical, Dental, Vision, Life, PTO

Posted 27 days ago

Gilead Sciences rating

9.7

Company rating: 9.7 out of 10

Based on 7 frontline employees who took The Breakroom Quiz

1st of 71 rated pharmaceutical

Job description

At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.

Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact.

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.
Job Description

TheCMC Regulatory Affairs Manageris responsible forsupporting the planning, coordination, and execution of CMC regulatory activities across global clinical and commercial programs. This role partners closely with Regulatory Affairs, Technical Development, Quality, and crossfunctional CMC teams to supporttimely, compliant, and wellorganized submissions to global health authorities.

Responsibilities:

  • Coordinate and tracktimelyregulatory assessments of CMC change controls to support global filing impacts for the development of CMC filing strategies and timelines

  • Support and track CMC regulatory project activities, including global quality dossier preparation, global dossier lifecycle submissions, approval, and Health Authority communications/interactions.

  • Manage CMC RA product team meetings (i.e., meeting agendas, meeting materials, document meeting minutes, discussionoutcomesand follow-up onaction items). Compile andmonitorproduct portfolio including scope, priorities,milestonesand emerging regulatory risks to product variants

  • Maintain and track global CMC regulatory filing plans, project timelines, and metrics that support visibility, alignment, and execution across product variants.

  • Coordinate CMC RA product team and technical content author activities to ensure highqualitysubmissioncontent through stakeholder engagement, clear communication, andtimelyresolution of issues.

  • Track and organize CMC filing related documentation (e.g., data availability timelines, validation data, specifications, analytical methods, stability data, Module 3 content).

  • Support regulatory strategy development byidentifyingand tracking regulatoryfileabilityrisks,track.

  • Lead meetinglogisticsand documentation, including agendas, minutes, and action item tracking, and followup.

  • Serve as a liaison with PDM product and portfolio Project Managers for CMC RA topics, including timelines and project milestones for preparation of global regulatory submissions, Health Authority briefing packages, responses, and meeting materials.

  • Contribute to process improvements, bestpractice development, and regulatory CMC initiatives.

Basic Qualifications:

  • Bachelor's degree in Life Sciences, Chemistry, Pharmacy, or related discipline.

  • 4-6+ years of relevant experience in pharmaceuticalproject, CMC development, CMC Regulatory Affairs.

Preferred Qualifications:

  • Excellent organizational, timemanagementandproblem solvingskills.

  • Excellent communication, and interpersonal skills.

  • High attention to detail and strong ability to think critically.

  • Ability to work collaboratively in a fast-paced, dynamic environment.

  • Regulatory Affairs Certification a plus.


The salary range for this position is: $146,540.00 - $189,640.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.

For additional benefits information, visit:

https://www.gilead.com/careers/compensation-benefits-and-wellbeing

* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.


For jobs in the United States:

Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability,genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact ApplicantAccommodations@gilead.comfor assistance.


For more information about equal employment opportunity protections, please view the'Know Your Rights' poster.

NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT


Gilead Sciences will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law.

Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.


Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.


For Current Gilead Employees and Contractors:

Please apply via the Internal Career Opportunities portal in Workday.

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