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Full Time Director Cmc Regulatory Jobs (NOW HIRING)

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

$176.2K

$248.5K

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

As of Aug 23, 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 2% As Needed, 86% Full Time, 9% Part Time, and 3% Contract. Highlights an 89% Physical, 4% Hybrid, and 7% Remote job distribution, with an average salary of $176,150 per year, or $84.7 per hour.

Director, CMC Regulatory

Corvus Pharmaceutical

South San Francisco, CA • On-site

Full-time

Re-posted 10 days ago

Job description

Corvus Pharmaceutical is a clinical-stage biopharmaceutical company developing novel therapies with the potential to significantly improve the treatment of immune diseases and cancer.  Our lead program, Soquelitnib, is a first-in-class, oral therapy that selectively inhibits ITK to modulate and control parallel signaling pathways in the immune system.

Reporting to the Vice President of Regulatory Affairs, the Director of Regulatory Affairs CMC will serve as a key member of the Regulatory organization, responsible for developing and executing global Chemistry, Manufacturi ng, and Controls (CMC) regulatory strategies for clinical-stage small molecule programs. 
This individual will partner cross-functionally with CMC, Technical Operations, Quality, and Clinical teams to ensure timely, compliant, and high-quality regulatory submissions and lifecycle management activities.

ROLE AND RESPONSIBILITIES

• Develop and execute global CMC regulatory strategies across all phases of development (IND/CTA through 

NDA/MAA and lifecycle management)

• Provide strategic input and regulatory guidance on manufacturing changes, comparability approaches, and 

control strategies

• Anticipate regulatory risks and propose mitigation strategies aligned with agency expectations (e.g. FDA, 

EMA, Health Canada, PMDA)

• Lead preparation and authorship of CMC sections (Module 2.3, 3) for: INDs/CTAs/Amendments

• Lead preparation of CMC Briefing documents and health authority interactions

• NDA/MAA and supplements/variations preparation and submissions

• Ensure alignment of CMC documentation with overall regulatory strategy and program timelines

• Oversee document quality, consistency, and compliance with global regulatory requirements

• Represent regulatory in change control assessments

• Support inspection readiness activities in collaboration with Quality and Manufacturing teams

QUALIFICATIONS AND EDUCATION REQUIREMENTS

• Bachelor’s degree in life sciences or related field required; advanced degree (MS, PhD, PharmD) preferred

• Minimum of 10+ years of regulatory affairs experience in biotech/pharma

PREFERRED SKILLS

• Experience supporting small molecules required (familiarity with additional modalities

desirable).

• Experience with IND/CTA, NDA/MAA compilation and submissions.

• Deep knowledge of CMC development for small molecules, Module 3 structure and 

expectations, and comparability and change management strategies.

• Familiarity with global regulatory frameworks (FDA, EMA, ICH guidelines)

• Proven ability to operate effectively in a small, fast-paced biotech environment

• Strong cross-functional leadership and influencing skills without direct authority

• Excellent written and verbal communication skills, with the ability to translate complex CMC topics into clear regulatory strategies

Salary Range: $230,000 to $270,000

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