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Cmc Manager Jobs (NOW HIRING)

Staffingine LLC

CMC Writer

Paramus, NJ · On-site

Manage timelines and deliverables for CMC workstreams, ensuring alignment with project goals. * Prepare and coordinate CMC documentation for AR, DSUR, and responses to regulatory authority questions.

Staffingine LLC

CMC Writer

Paramus, NJ · On-site

Project management skill is plus * Author and review CMC sections of regulatory submissions, including IND, NDA, and MAA applications. * Ensure documents align with FDA, EMA, and ICH regulatory ...

Atomic

CMC Consultant

This individual will play a critical role in advancing our lead asset through the NDA pathway by guiding CMC development, managing external partners, and ensuring regulatory readiness. This role is ...

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$23K

$61.4K

$102.5K

How much do cmc manager jobs pay per year?

As of Jul 13, 2026, the average yearly pay for cmc manager in the United States is $61,351.00, according to ZipRecruiter salary data. Most workers in this role earn between $44,000.00 and $69,000.00 per year, depending on experience, location, and employer.

What is the highest paying job in regulatory affairs?

The highest paying roles in regulatory affairs are typically senior executive positions such as Vice President or Director of Regulatory Affairs, which can offer salaries exceeding $150,000 annually. These roles often require extensive experience, leadership skills, and knowledge of regulatory compliance, often supported by advanced certifications like RAC (Regulatory Affairs Certification).

What are CMC Managers?

CMC Managers, or Chemistry, Manufacturing, and Controls Managers, are professionals responsible for overseeing the development, production, and quality control processes of pharmaceutical products. They ensure that all aspects of drug manufacturing comply with regulatory standards and that the product is safe, effective, and consistent. CMC Managers coordinate between research, development, regulatory affairs, and production teams to streamline processes and solve technical issues. Their work is crucial for securing regulatory approval and bringing medicines to market efficiently.

What are some common challenges a CMC Manager faces when coordinating cross-functional teams during drug development?

A CMC Manager often navigates complex challenges such as aligning timelines and priorities between research, manufacturing, quality assurance, and regulatory teams. Ensuring effective communication and data transfer across departments is crucial, especially when dealing with global teams or external partners. Additionally, adapting to evolving regulatory requirements and managing resource constraints while maintaining project momentum are frequent hurdles. Success in this role relies on strong project management, problem-solving skills, and the ability to build collaborative relationships across diverse functional areas.

What is a CMC position?

A CMC (Chemistry, Manufacturing, and Controls) manager is responsible for overseeing the development, manufacturing, and regulatory compliance of pharmaceutical products. They ensure that drug development processes meet quality standards and regulatory requirements, often working closely with cross-functional teams and regulatory agencies.

What are the key skills and qualifications needed to thrive as a CMC Manager, and why are they important?

To thrive as a CMC Manager, you need expertise in chemistry, manufacturing, and controls (CMC) regulations, drug development processes, and a relevant scientific degree, often with experience in the pharmaceutical or biotechnology industry. Familiarity with regulatory submission systems, quality management software, and documentation tools such as eCTD is typically required. Strong project management, leadership, and cross-functional communication skills help coordinate teams and manage complex timelines. These competencies are vital for ensuring regulatory compliance, efficient product development, and successful market approval.

What is a CMC manager?

A CMC manager, or Chemistry, Manufacturing, and Controls manager, oversees the development, manufacturing, and regulatory compliance of pharmaceutical products. They coordinate activities related to drug formulation, quality assurance, and documentation to ensure products meet industry standards and regulatory requirements. Strong knowledge of GMP guidelines and regulatory submissions is essential for this role.

What is the highest paying management job?

The highest paying management jobs are often executive roles such as Chief Executive Officer (CEO), Chief Financial Officer (CFO), or Chief Operating Officer (COO), with salaries frequently exceeding several hundred thousand dollars annually. These positions typically require extensive experience, leadership skills, and advanced degrees, and they often involve overseeing large organizations or divisions.

What is the difference between Cmc Manager vs Cmc Specialist?

AspectCmc ManagerCmc Specialist
CredentialsBachelor's or Master's in Life Sciences, Chemistry, or related field; often requires industry certificationsSimilar educational background; certifications may enhance prospects
Work EnvironmentOversees teams, manages projects, liaises with regulatory agenciesExecutes specific tasks within projects, supports Cmc managers
ResponsibilitiesStrategic planning, team leadership, regulatory submissionsData 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.

More about Cmc Manager jobs
What cities are hiring for Cmc Manager jobs? Cities with the most Cmc Manager job openings:
What are the most commonly searched types of Cmc jobs? The most popular types of Cmc jobs are:
What states have the most Cmc Manager jobs? States with the most job openings for Cmc Manager jobs include:
Cmc Manager jobs near you
Infographic showing various Cmc Manager job openings in the United States as of July 2026, with employment types broken down into 25% Internship, 1% As Needed, 59% Full Time, 10% Part Time, 2% Contract, and 3% Summer. Highlights an 91% Physical, 2% Hybrid, and 7% Remote job distribution, with an average salary of $61,351 per year, or $29.5 per hour.

Senior Manager, Global Regulatory Affairs CMC

The businesses of Merck KGaA, Darmstadt, Germany

Billerica, MA • On-site

$134K - $202K/yr

Full-time

Medical, Retirement, PTO

Re-posted yesterday

Job description

Work Location: Billerica, Massachusetts
Shift:
Department: HC-RD-RCD1 Reg CMC LM Marketed 1
Recruiter:Sarah Ellis


This information is for internals only. Please do not share outside of the organization.


Your Role:

The Senior Manager Regulatory CMC (RCMC) is responsible and accountable for driving all CMC regulatory activities including development, authoring and ownership of the CMC dossier Strategy Document as well as all CMC Dossier types, their content and decision making on content, for assigned submissions worldwide, and serves as the Regulatory Affairs CMC contact point and acts as the liaison with the GHO and R&D functions, being the contact person for all Regulatory CMC topics.

Location: Hybrid (3x/week) in Billerica, MA office

Key Accountabilities:

Global Product Oversight:

  • Ensures global product oversight for the regulatory CMC part of the product / project

Regulatory CMC strategy and Health Authority interactions:

  • Develops, defines and is accountable for the Global Regulatory CMC strategy for development and Life Cycle Management programs. Leads and drives global regulatory CMC strategy for the assigned projects/products in target regions/countries. This encompasses responsibility for the Regulatory CMC topics, risk assessment & mitigation, regulatory CMC strategic support and advice to interdisciplinary internal teams
  • Leads HA meetings and represents GRA in Health Authority interactions on CMC topics

Management of CMC Regulatory Activities; CMC Dossier generation:

  • Responsible and accountable for driving all regulatory CMC activities for assigned projects/products. Develops, authors and owns the CMC dossier Strategy Document as well as all CMC Dossier types; being accountable for CMC Dossier content and content decision of all CMC Dossier types such as IMPD/IND, BB (incl. meeting request), variations, amendments, renewals, Module 1 CMC regulatory binding documents, Annual reports, IB CMC, ATOs up to approval.
  • Provides the Global Regulatory CMC advice & expertise in cross-functional project teams.
  • Acts as liaison between Global Health Operations and R&D functions as single point of contact for all CMC topics.
  • Accountable and responsible to provide country specific regulatory CMC requirements for CMC dossier strategies and plans.
  • Regulatory CMC assessment of in-and out licensing projects for business development (Due Diligence).

Regulatory intelligence and knowledge management:

  • Is the expert for CMC regulations, guidance, regulatory trends and competitive environment, incl. accelerated pathways, CMC innovations
  • Reviews draft and newly released laws and guidance on behalf of the Company. If required, being a member in trade associations. Leading and participation in internal as well as cross-functional, international initiatives.

Global Regulatory Affairs CMC coordination:

  • Support development and execute initiatives
  • Plans regulatory CMC activities and develops submission roll-out plans, in close collaboration with key stakeholders

Who You Are:

Minimum Qualifications:

  • Degree in a Life Science or related discipline (e.g. MSc or equivalent degree, PhD in a scientific discipline is preferred)
  • 7+ years of pharmaceutical industry experience, with global regulatory CMC experience

Preferred Qualifications:

  • Ability to develop and prepare successful regulatory CMC strategies and CMC dossiers
  • Experience in preparation and management of regulatory CMC documentation, a full international submission (new product application) or large variations
  • Experience with life-cycle management activities in EU, USA and International
  • US regulation expertise
  • Practical experience in one of the following area: manufacturing process development, transfers, validation or analytical development and control strategies
  • In-depth knowledge of global pharmaceutical legislation

Pay Range for this position: $134,200 - 202,200

The offer range represents the anticipated low and high end of the base pay compensation for this position. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. Position may be eligible for sales or performance-based bonuses. Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other prerequisites. For more information click here.


The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.

Employment Type: FULL_TIME

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