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Regulatory Affairs Program Manager Jobs in Santa Rosa, CA

Alumis

Vice President, Medical Affairs

Bodega Bay, CA · On-site

$315K - $370K/yr

Develop and present Medical Affairs operational plans to Development and Executive management ... An understanding of government and industry guidelines, regulations, laws, etc., for appropriate ...

Block

AI Legal Program Manager

Bodega Bay, CA · On-site

The Role As AI Legal Program Manager, you will play a key role in navigating the legal and regulatory landscape of Block's artificial intelligence initiatives. You will partner with legal ...

Constellation Brands

Quality Control Manager

Sonoma, CA · On-site

$100K - $153K/yr

... Regulatory Affairs, and Commercial teams to ensure world-class quality standards throughout the ... Support food safety programs including hazard analysis, risk management, sanitation verification ...

Constellation Brands

Quality Control Manager

Napa, CA

... Regulatory Affairs, and Commercial teams to ensure world-class quality standards throughout the ... Support food safety programs including hazard analysis, risk management, sanitation verification ...

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All JobsRegulatory Affairs Program JobsRegulatory Affairs Program Manager JobsRegulatory Affairs Program Manager Jobs in Santa Rosa, CA

Regulatory Affairs Program Manager information

See Santa Rosa, CA salary details

$31

$62

$94

How much do regulatory affairs program manager jobs pay per hour?

As of Sep 6, 2026, the average hourly pay for regulatory affairs program manager in Santa Rosa, CA is $62.28, according to ZipRecruiter salary data. Most workers in this role earn between $46.01 and $72.79 per hour, depending on experience, location, and employer.

What does a regulatory affairs program manager do?

A Regulatory Affairs Program Manager oversees and coordinates regulatory activities to ensure that a company's products comply with all applicable laws and regulations. They manage submission processes for product approvals, communicate with regulatory agencies, and develop strategies to maintain compliance throughout the product lifecycle. Additionally, they collaborate with cross-functional teams such as research and development, quality assurance, and manufacturing to align regulatory requirements with business objectives. Their role is crucial in minimizing regulatory risks and accelerating the time to market for new products.

What are some typical challenges faced by regulatory affairs program managers when coordinating cross-functional teams?

Regulatory Affairs Program Managers often encounter challenges in aligning the objectives and timelines of different departments such as clinical, quality, and R&D. Balancing varying priorities, managing tight submission deadlines, and ensuring consistent communication between teams are common hurdles. Successful Program Managers proactively foster collaboration, clarify regulatory requirements, and facilitate regular updates to keep projects on track. Being able to anticipate and resolve conflicts, while adapting to evolving regulations, is key to driving effective program execution.

What are the key skills and qualifications needed to thrive as a regulatory affairs program manager, and why are they important?

To thrive as a Regulatory Affairs Program Manager, you need expertise in regulatory guidelines, project management, and a relevant science or healthcare degree. Familiarity with regulatory submission systems, document management tools, and certifications such as RAC (Regulatory Affairs Certification) are highly beneficial. Strong attention to detail, strategic communication, and collaborative problem-solving are crucial soft skills in this role. These competencies ensure efficient navigation of complex regulatory requirements, timely submissions, and successful product approvals.

What is the difference between Regulatory Affairs Program Manager vs Regulatory Affairs Specialist?

AspectRegulatory Affairs Program ManagerRegulatory Affairs Specialist
CredentialsTypically requires a bachelor’s degree in life sciences, regulatory affairs certification (RAC) preferredUsually holds a bachelor’s degree in life sciences or related field; RAC certification is a plus
Work EnvironmentManages multiple projects, oversees teams, and collaborates with cross-functional departmentsFocuses on preparing and submitting regulatory documents, supporting project teams
Employer & Industry UsageUsed in pharmaceutical, biotech, and medical device companies for leadership rolesCommonly employed in similar industries for entry- to mid-level regulatory roles

The Regulatory Affairs Program Manager oversees regulatory strategies and manages teams, while the Regulatory Affairs Specialist handles document preparation and submission. Both roles require relevant credentials and are vital in ensuring compliance within regulated industries.

Is regulatory affairs high paying?

Regulatory Affairs Program Managers typically earn competitive salaries that reflect their specialized knowledge of regulations, compliance, and industry standards. Salaries can vary based on experience, location, and the complexity of the regulatory environment, with many roles offering above-average compensation in the healthcare, pharmaceutical, and biotech sectors.

What job categories do people searching Regulatory Affairs Program Manager jobs in Santa Rosa, CA look for?

The top searched job categories for Regulatory Affairs Program Manager jobs in Santa Rosa, CA are:

What cities near Santa Rosa, CA are hiring for Regulatory Affairs Program Manager jobs?

Cities near Santa Rosa, CA with the most Regulatory Affairs Program Manager job openings:

Regulatory Affairs Program Manager jobs near you

Senior Regulatory Submission Lead

Penfield Search Partners

Bodega Bay, CA

$120 - $175/hr

Full-time

Re-posted 15 days ago

Job description

Job Description Contact: Alexandra Spink - aspink@penfieldsearch.com No 3rd party candidates Location: Bay Area-based role Work Model: 5 days onsite per week We are seeking a Senior Regulatory Submission Lead to support a critical BLA submission across Module 2 and Module 5. This 1 year contract role will provide hands-on submission execution and cross-functional coordination to ensure regulatory content is aligned, complete, and ready for filing. Key Responsibilities Coordinate BLA submission activities across Module 2 and Module 5, including timelines, deliverables, and submission readiness

Support preparation and review of submission content, including CSRs, appendices, ISS, ISE, and related regulatory documentation. Ensure clinical and biometrics outputs are incorporated into accurate, regulatory-ready submission content. Manage submission documentation, QC, version control, and workflows within Veeva Vault.

Support eCTD publishing activities and FDA-facing submission needs. Identify gaps, track dependencies, and help maintain submission timelines. Qualifications 7+ years of experience supporting regulatory submissions within the life sciences industry.

Advanced scientific or clinical training preferred (PhD, PharmD, or MD), with prior ophthalmology experience strongly preferred. Hands-on BLA submission experience with strong knowledge of FDA Module 2 and Module 5 requirements. Experience independently coordinating submission activities from planning through filing, including FDA interactions and regulatory communications.

Hands-on experience using Veeva Vault to support regulatory submissions, including document management, workflows, QC, and submission readiness, with a strong understanding of eCTD processes and publishing activities. Success in This Role The successful candidate will quickly step into an active BLA submission environment, coordinate across functions, and help ensure Module 2 and Module 5 deliverables remain aligned and submission-ready through filing. Hourly Rate: $120-$175/hour.

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