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Cmc Contract Jobs (NOW HIRING)

CMC Hotels

Sales & Catering Manager

Charlotte, NC

$50K - $65K/yr

CMC Hotels provides that opportunity. At CMC Hotels, we believe in Growing People . Our people are ... Prepare proposals, contracts, banquet event orders (BEOs), menus, group resumes, and other event ...

US Tech Solutions

CMC Manager

Morristown, NJ · On-site

Work with manufacturing sites and contract sites to ensure the on-time compilation of high quality CTD Module III documents * Evaluate and manage the Technical CMC dossier documentation involved in ...

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Cmc Contract information

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$17

$26

$49

How much do cmc contract jobs pay per hour?

As of Sep 13, 2026, the average hourly pay for cmc contract in the United States is $26.18, according to ZipRecruiter salary data. Most workers in this role earn between $20.19 and $28.61 per hour, depending on experience, location, and employer.

What is the difference between Cmc Contract vs Cmc Coordinator?

AspectCmc ContractCmc Coordinator
Required CredentialsTypically requires a degree in life sciences or related field, with experience in contract managementUsually requires a degree in life sciences, with some experience in project coordination or administration
Work EnvironmentWorks primarily in legal, regulatory, or contract management departments within biotech or pharma companiesWorks in project teams, supporting CMC activities in pharmaceutical or biotech settings
Employer & Industry UsageCommonly employed in pharmaceutical, biotech, and contract research organizationsFound in similar industries, often supporting CMC teams in drug development

The main difference is that a Cmc Contract focuses on managing and negotiating contracts related to CMC activities, while a Cmc Coordinator handles the coordination and administrative support within CMC projects. Both roles require familiarity with CMC processes, but their responsibilities and focus areas differ.

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Cmc Contract jobs near you
Infographic showing various Cmc Contract job openings in the United States as of September 2026, with employment types broken down into 1% As Needed, 80% Full Time, 17% Part Time, and 2% Contract. Highlights an 82% Physical, 2% Hybrid, and 16% Remote job distribution, with an average salary of $54,445 per year, or $26.2 per hour.

Director Regulatory Affairs - CMC

San Diego, CA

Clinical Dynamix, Inc.
See more jobs at Clinical Dynamix, Inc.external

$160K - $211K/yr

Full-time

Re-posted 9 days ago

Key responsibilities

  • Lead the development and management of regulatory CMC strategies for assigned commercial and development projects.

  • Prepare, review, and submit regulatory documents such as INDs, CTAs, MAAs, NDAs, and BLAs, and interact with regulatory agencies during all stages of development and registration.

  • Provide strategic guidance on global regulatory CMC requirements and act as a liaison with partner companies and contract manufacturers.

Job description

About the Role:

Responsible for the strategic Regulatory CMC leadership for assigned commercial products to ensure regulatory compliance with the approved marketing applications (MAA/NDA/BLA) and assigned development projects leading to successful preparation and clearance/approval of IND/CTA/MAA/NDA/BLA submissions in a timely and efficient manner.

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Your Contributions (include, but are not limited to):

  • Responsible for the regulatory CMC leadership of one or more commercial and development projects, including responsibility for regulatory strategy, IND/CTA preparation, maintenance and update activities, interaction with and preparation for key milestone meetings with regulatory agencies with focus on the CMC aspects
  • Develops CMC regulatory strategies to ensure optimal product development leading to the earliest possible approvals by relevant regulatory authorities
  • Provides strategic guidance on global regulatory CMC requirements to management and project teams
  • Provides guidance to senior management and departments within CMC areas on all regulatory issues for the strategic development, planning, compilation and submission of assigned IND/CTA/MAA/NDA/BLA
  • May represent the company by leading interactions and negotiations with regulatory agencies during all stages of development and registration
  • Manages preparation of assigned regulatory submissions (IND/CTA/MAA/NDA/BLA)
  • Reviews and approves reports intended for use in regulatory submissions
  • Actively engages with stakeholder groups to help shape science based regulatory decision making
  • Acts as regulatory CMC liaison with partner companies and contract manufacturers
  • Provides expertise in translating regulatory requirements into practical, workable plans
  • Interacts with regulatory agencies for assigned projects
  • Selects, develops and evaluates personnel to ensure the efficient operation of the function
  • Other duties as assigned

Requirements:

  • BS/BA degree AND 12+ years experience in Regulatory Affairs in the Pharmaceutical/Biotech industry. Prior project regulatory leadership experience with specific focus on the CMC aspects for small molecules, biologics, and/or gene therapies. Leadership experience in preparation and preferably, negotiation to marketing approval in major markets is desired. OR
  • Master's degree preferred AND 10+ years similar experience noted above OR
  • PhD preferred AND 7+ years similar experience noted above OR
  • Extensive previous managerial experiences also required
  • Acts as a "trusted advisor" across the company and may be recognized as an external expert
  • Provides strategy, vision and direction regarding issues that may have company-wide impact
  • Requires in-depth knowledge of the functional area, business strategies, and the company’s goals
  • Possesses industry-leading knowledge
  • Ability to apply advanced analytical thought and judgment
  • Strong leadership, coaching, employee development skills
  • Ability to influence others with or without authority at all levels of the organization
  • Proactive, innovative, with excellent problem-solving skills
  • Ability to work in a cross functional team and matrix environment
  • Excellent written, presentation, and verbal communication skills
  • Extensive project regulatory leadership and expertise, specifically focused on the CMC aspects for small molecules, biologics, and/or gene therapies
  • Detailed knowledge of FDA and EMA regulations and guidance for drug development, preparation and management of IND/CTA/MAA/NDA/BLA
  • Demonstrated leadership expertise in preparation and preferably, negotiation to marketing approval in major markets