ZipRecruiter

Log In

1

Home Based 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 ...

Vaxcyte

Associate Director, Regulatory CMC

San Carlos, CA · On-site

$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 ...

next page

Showing results 1-20

All Jobsremote JobsGovernment JobsGovernment Services JobsHome Based Director Cmc Regulatory Jobs

Home Based Director Cmc Regulatory information

See salary details

$91K

$176.2K

$248.5K

How much do home based director cmc regulatory jobs pay per year?

As of Aug 26, 2026, the average yearly pay for home based 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 the difference between Home Based Director Cmc Regulatory vs Home Based Cmc Regulatory Associate?

AspectHome Based Director Cmc RegulatoryHome Based Cmc Regulatory Associate
CredentialsTypically requires advanced degrees (e.g., MS, PhD) and extensive regulatory experienceUsually requires a bachelor's or master's degree with some regulatory experience
Work EnvironmentLeadership role overseeing regulatory strategies, often managing teams remotelySupport role focusing on regulatory submissions and documentation, often remote
Industry UsageUsed in pharmaceutical and biotech companies for senior regulatory positionsCommon in similar industries for entry to mid-level regulatory roles

The main difference between a Home Based Director Cmc Regulatory and a Home Based Cmc Regulatory Associate lies in their level of responsibility, experience, and scope of work. The director oversees regulatory strategies and manages teams, requiring advanced credentials and extensive experience. In contrast, the associate supports regulatory documentation and submissions, typically with less experience and responsibility. Both roles are often remote and integral to pharmaceutical and biotech industries, but they differ significantly in seniority and scope.

More about Home Based Director Cmc Regulatory jobs

What cities are hiring for Home Based Director Cmc Regulatory jobs?

Cities with the most Home Based Director Cmc Regulatory job openings:

What states have the most Home Based Director Cmc Regulatory jobs?

States with the most job openings for Home Based Director Cmc Regulatory jobs include:

What job categories do people searching Home Based Director Cmc Regulatory jobs look for?

The top searched job categories for Home Based Director Cmc Regulatory jobs are:

Home Based Director Cmc Regulatory jobs near you
Infographic showing various Home Based Director Cmc Regulatory job openings in the United States as of August 2026, with employment types broken down into 1% As Needed, 79% Full Time, 13% Part Time, and 7% Contract. Highlights an 83% Physical, 2% Hybrid, and 15% Remote job distribution, with an average salary of $176,150 per year, or $84.7 per hour.

Director, CMC Regulatory

South San Francisco, CA • On-site

Corvus Pharmaceutical
See more jobs at Corvus Pharmaceuticalexternal

Full-time

Re-posted 13 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

Powered by JazzHR

p5RFBEBp7g