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Full Time Director Cmc Regulatory Jobs (NOW HIRING)

Kardigan

Senior Director, CMC Regulatory

Princeton, NJ

$157K - $207K/yr

Senior Director, CMC Regulatory Department: Regulatory Affairs Reports To : Head of CMC Regulatory Location: Princeton, NJ (onsite 4 days per week) Job Overview Kardigan is seeking a Senior Director ...

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Kardigan

Senior Director, CMC Regulatory

Princeton, NJ · On-site

$241K - $300K/yr

Senior Director, CMC Regulatory Department: Regulatory Affairs Reports To : Head of CMC Regulatory Location: Princeton, NJ (onsite 4 days per week) Job Overview Kardigan is seeking a Senior Director ...

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Vaxcyte

Associate Director, Regulatory CMC

San Carlos, CA · On-site +1

$180K - $210K/yr

Executive Director, CMC Regulatory Location: San Carlos, CA / US Remote Work Arrangement: Remote Compensation: The compensation package will be competitive and includes comprehensive benefits and an ...

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Full Time Director Cmc Regulatory information

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$91K

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How much do full time director cmc regulatory jobs pay per year?

As of Aug 29, 2026, the average yearly pay for full time director cmc regulatory in the United States is $176,150.00, according to ZipRecruiter salary data. Most workers in this role earn between $150,000.00 and $198,000.00 per year, depending on experience, location, and employer.

What is a full time director CMC regulatory?

A Full Time Director CMC Regulatory is a senior leadership position responsible for managing all Chemistry, Manufacturing, and Controls (CMC) regulatory activities within a pharmaceutical or biotechnology company. This role ensures that products meet global regulatory requirements for quality, safety, and efficacy throughout development and commercialization. The director oversees regulatory submissions, interacts with health authorities, and leads cross-functional teams to ensure compliance with relevant guidelines. They play a key role in developing regulatory strategies, risk assessments, and managing the CMC documentation required for product approvals.

What are the key skills and qualifications needed to thrive as a full time director CMC regulatory?

To excel as a Full Time Director CMC Regulatory, you need deep expertise in chemistry, manufacturing, and controls (CMC) regulations, typically supported by an advanced degree in life sciences and significant regulatory affairs experience. Familiarity with regulatory submission systems (such as eCTD), project management tools, and global regulatory guidelines (FDA, EMA, ICH) is crucial. Outstanding leadership, strategic thinking, and effective communication skills help navigate complex cross-functional teams and regulatory challenges. These competencies ensure timely and compliant product development, successful regulatory submissions, and market approvals.

What are some common challenges faced by a full time director CMC regulatory, and how can they be effectively managed?

A Full Time Director CMC Regulatory often encounters challenges related to navigating complex global regulatory requirements, aligning cross-functional teams, and ensuring timely submission of high-quality CMC documentation. Managing these challenges effectively involves staying updated on evolving regulations, fostering close collaboration with R&D, manufacturing, and quality teams, and implementing robust project management practices. Proactive communication and early engagement with regulatory authorities can also help anticipate and resolve potential issues, ensuring smoother approval processes.

What is the difference between Full Time Director Cmc Regulatory vs Regulatory Affairs Manager?

AspectFull Time Director Cmc RegulatoryRegulatory Affairs Manager
CredentialsAdvanced degree in life sciences, extensive CMC experience, regulatory certificationsBachelor's or Master's in life sciences, regulatory certifications preferred
Work EnvironmentStrategic leadership, cross-functional teams, senior managementOperational focus, project management, team supervision
Employer & Industry UsagePharmaceutical and biotech companies, regulatory agenciesPharmaceutical companies, contract research organizations
Search & Comparison IntentUnderstanding senior regulatory roles, leadership in CMCOperational regulatory roles, team management

The Full Time Director Cmc Regulatory typically holds a senior leadership position with strategic responsibilities, requiring extensive experience and advanced credentials. In contrast, the Regulatory Affairs Manager focuses on operational tasks, team oversight, and project execution. Both roles are essential in the regulatory landscape but differ mainly in scope, seniority, and strategic involvement.

More about Full Time Director Cmc Regulatory jobs

What job categories do people searching Full Time Director Cmc Regulatory jobs look for?

The top searched job categories for Full Time Director Cmc Regulatory jobs are:

Full Time Director Cmc Regulatory jobs near you
Infographic showing various Full Time Director Cmc Regulatory job openings in the United States as of August 2026, with employment types broken down into 1% As Needed, 88% Full Time, 8% Part Time, and 3% Contract. Highlights an 86% Physical, 3% Hybrid, and 11% Remote job distribution, with an average salary of $176,150 per year, or $84.7 per hour.

Senior Director, CMC Regulatory

Princeton, NJ

Kardigan
See more jobs at Kardiganexternal

$157K - $207K/yr

Full-time

Posted 2 days ago

New

Job description

Position Title: Senior Director, CMC Regulatory

Department: Regulatory Affairs

Reports To: Head of CMC Regulatory

Location: Princeton, NJ (onsite 4 days per week)

Job Overview

Kardigan is seeking a Senior Director, CMC Regulatory to support Kardigan's mission to develop multiple targeted treatments in parallel that bring people with cardiovascular diseases closer to the cures they deserve. The Senior Director will be responsible for leading CMC Regulatory activities to help advance Kardigan's late-stage clinical assets through clinical development and towards marketing approval. We are looking for a highly motivated individual who will help define CMC Regulatory strategies and successfully execute them in submissions and health authority interactions, in close collaboration with cross-functional partners. This position will report to the Head of CMC Regulatory.

 

Essential Duties and Responsibilities

  • Lead the development and execution of CMC regulatory strategies, working in close collaboration with cross-functional teams to ensure regulatory strategies are aligned with program objectives and timelines
  • Proactively manage regulatory CMC aspects of programs to ensure on-time delivery of global, high-quality submissions across all development-stage programs
  • Manage regulatory interactions with global health authorities, including meeting preparation and participation, responses to questions, and negotiations.
  • Provide regulatory expertise on CMC strategies to cross-functional teams, anticipating regulatory concerns, and proposing innovative solutions.
  • Ensure compliance with relevant global CMC requirements (FDA, EMA, and ICH guidelines), and proactively monitor regulatory trends, guidance documents and changes to existing regulations.
  • Evaluates proposed manufacturing and quality changes for impact to ongoing and existing submissions and provides strategic regulatory guidance for optimal implementation of changes.
  • Help develop and implement department practices, policies, processes, and SOPs
  • Manage internal or external staff as needed

 

Qualifications and Preferred Skills

  • Bachelor's degree in scientific discipline required, advanced degree in Chemistry preferred
  • Minimum of 10 years industry experience with majority of experience in CMC Regulatory Affairs or related roles
  • Experience with global early and late phase submissions (IND/IMPD and NDA/MAA, amendments, and annual reports) and health authority interactions
  • Prior small molecule experience preferred
  • Excellent knowledge of FDA, EMA and ICH regulatory guidelines and regulations
  • Collaborate and communicate well with all levels of employees, including peers, executives and cross-functionally
  • Strong interpersonal, communication (oral and written), and organizational skills
  • Ability to handle and prioritize multiple assignments, and work in a fast-paced environment.

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