ZipRecruiter

Log In

1

Director Cmc Regulatory Jobs in Basking Ridge, NJ

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 ...

New

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 ...

New

Altimmune

CMC Director, Regulatory Affairs

Morristown, NJ · On-site

$154K - $204K/yr

This individual will be responsible for providing global regulatory CMC support throughout the product lifecycle (e.g., regulatory strategies, preparing CMC filings and submissions to regulatory ...

MSD

Assoc. Dir, Regulatory Affairs-CMC

Rahway, NJ

The Associate Director, Regulatory CMC Digital Innovation is a key execution and enablement-focused role reporting to the Executive Director of Regulatory CMC Digital Innovation. The role will focus ...

next page

Showing results 1-20

All JobsCmc Regulatory JobsDirector Cmc Regulatory JobsDirector Cmc Regulatory Jobs in Basking Ridge, NJ

Director Cmc Regulatory information

See Basking Ridge, NJ salary details

$93.8K

$181.5K

$256.1K

How much do director cmc regulatory jobs pay per year?

As of Aug 29, 2026, the average yearly pay for director cmc regulatory in Basking Ridge, NJ is $181,532.00, according to ZipRecruiter salary data. Most workers in this role earn between $154,600.00 and $204,000.00 per year, depending on experience, location, and employer.

What is a Director CMC Regulatory?

A Director CMC (Chemistry, Manufacturing, and Controls) Regulatory oversees the regulatory strategy for the development, approval, and lifecycle management of pharmaceutical and biologic products. They ensure compliance with global regulations, provide guidance on CMC-related submissions, and collaborate with cross-functional teams to support product development. This role involves working with health authorities, managing regulatory filings, and mitigating potential compliance risks.

What are the key skills and qualifications needed to thrive as a Director CMC Regulatory?

To thrive as a Director Cmc Regulatory, you need an in-depth knowledge of global regulatory requirements for Chemistry, Manufacturing, and Controls (CMC), often supported by an advanced degree in life sciences or pharmacy and extensive regulatory experience. Familiarity with regulatory submission systems (such as eCTD), ICH guidelines, and relevant certification (e.g., RAC) is highly valuable. Exceptional leadership, strategic communication, and cross-functional collaboration skills set successful candidates apart. Mastery of these competencies ensures effective compliance strategies, successful product submissions, and strong relationships with regulatory agencies.

What are some typical challenges faced by a Director CMC Regulatory, and how can they be overcome?

Directors of Cmc Regulatory often navigate complex and constantly evolving global regulations, balancing the need for compliance with the fast pace of product development. Adapting to stringent deadlines, coordinating with cross-functional teams such as R&D, manufacturing, and quality, and managing multiple projects are common challenges. Success in the role requires proactive planning, strong communication, and a deep understanding of regulatory expectations. Leveraging experience and staying updated with industry changes can help mitigate risks and drive successful regulatory submissions.

What are popular job titles related to Director Cmc Regulatory jobs in Basking Ridge, NJ?

For Director Cmc Regulatory jobs in Basking Ridge, NJ, the most frequently searched job titles are:

What job categories do people searching Director Cmc Regulatory jobs in Basking Ridge, NJ look for?

The top searched job categories for Director Cmc Regulatory jobs in Basking Ridge, NJ are:

What cities near Basking Ridge, NJ are hiring for Director Cmc Regulatory jobs?

Cities near Basking Ridge, NJ with the most Director Cmc Regulatory job openings:

Director Cmc Regulatory jobs near you
Infographic showing various Director Cmc Regulatory job openings in Basking Ridge, NJ as of August 2026, with employment types broken down into 2% As Needed, 84% Full Time, 10% Part Time, and 4% Contract. Highlights an 89% Physical, 4% Hybrid, and 7% Remote job distribution, with an average salary of $181,532 per year, or $87.3 per hour.

Senior Director, CMC Regulatory

Princeton, NJ

Kardigan
See more jobs at Kardiganexternal

$157K - $207K/yr

Full-time

Posted 3 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.

Apply