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Regulatory Affairs Program Manager Jobs in Santa Rosa, CA

BioTalent

Director Clinical Affairs

Santa Rosa, CA · On-site

$164K - $216K/yr

Director of Clinical Affairs We're seeking a Director of Clinical Affairs to own end-to-end ... program management across clinical, engineering, and regulatory * Strong clinical data management ...

BioTalent

Director Clinical Affairs

Sonoma, CA · On-site

$168K - $221K/yr

Director of Clinical Affairs We're seeking a Director of Clinical Affairs to own end-to-end ... program management across clinical, engineering, and regulatory * Strong clinical data management ...

Block

Regulatory Examination Manager

Bodega Bay, CA · On-site +1

The team manages direct bank examinations, multi-state money transmission and lending oversight ... regulatory affairs in financial services, with meaningful exposure to federal bank examinations

Buckelew Programs

PROGRAM MANAGER

Santa Rosa, CA · On-site

$90 - $110/hr

We are hiring a Program Manager to provide leadership, direction, and oversight to the new Buckelew ... Monitor compliance with legal, regulatory, and contractual requirements, including CARF, CCL, and ...

BUCKELEW PROGRAMS

PROGRAM MANAGER

Santa Rosa, CA

We are hiring a Program Manager to provide leadership, direction, and oversight to the new Buckelew ... Monitor compliance with legal, regulatory, and contractual requirements, including CARF, CCL, and ...

Buckelew

PROGRAM MANAGER

Santa Rosa, CA · On-site

$87K - $90K/yr

We are hiring a Program Manager to provide leadership, direction, and oversight to the new Buckelew ... Monitor compliance with legal, regulatory, and contractual requirements, including CARF, CCL, and ...

Ztek Consulting INC

Technical Program Manager

Bodega Bay, CA · On-site

$153K - $198K/yr

Technical Program Manager Location: Bay Area Position Type: Contract Duration: 6 / 12 Month Work ... rules, and regulations in the locations where it operates. If you are an individual with a ...

Agilent

Enterprise Program Manager

Bodega Bay, CA · On-site +1

$93K - $175K/yr

* The Enterprise Program Manager will support the sale and manages the development and/or delivery of ... regulation and will not be discriminated against on these bases. Agilent Technologies, Inc., is ...

LEAP of California

North Bay - Program Manager

Napa, CA · On-site

$95K/yr

As a Program Manager with LEAP, you'll be one of those extraordinary people. We are looking for a ... Create annual QA checks for homes and Home Providers that include both safety and HCBS regulations

LEAP of California

North Bay - Program Manager

Napa, CA · On-site

$65 - $85/hr

As a Program Manager with LEAP, you'll be one of those extraordinary people. We are looking for a ... Create annual QA checks for homes and Home Providers that include both safety and HCBS regulations

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Regulatory Affairs Program Manager information

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

As of Sep 5, 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 Manager, Regulatory Affairs and Compliance

Traditional Medicinals

Rohnert Park, CA • On-site

$155K - $204K/yr

Full-time

Posted 9 days ago

Job description

The Senior Manager, Regulatory Affairs & Compliance, is a cross-functional role responsible for helping Traditional Medicinals scale responsibly within an increasingly complex regulatory, certification, and compliance environment.
The role serves as the functional leader for Regulatory Affairs and Compliance at the Company, with responsibility for establishing regulatory strategy, providing authoritative regulatory guidance, and building and operating the systems, governance, and capabilities necessary to support the Company's growth. The role will also assume ownership of selected compliance responsibilities that are currently distributed across the organization as the Company continues to mature its compliance operating model. The ideal candidate is equally comfortable interpreting regulatory requirements, coordinating cross-functional compliance activities, supporting audit/inspection readiness, and building scalable processes that reduce reliance on fragmented/manual coordination.
Reporting to the Associate General Counsel, this role partners closely with Quality, Operations, Human Resources, Marketing, and Innovation to ensure the Company continues to operate responsibly and compliantly as the business, manufacturing footprint, and regulatory environment evolve.
Key Responsibilities
Regulatory Business Partnership
  • Serve as a trusted strategic advisor to business leaders, providing risk-based regulatory guidance that considers regulatory requirements alongside commercial objectives, operational realities, consumer impact, and organizational risk tolerance.
  • Partner with Innovation, Marketing, Legal, and Operations to provide proactive regulatory guidance supporting product innovation, portfolio expansion, and commercialization initiatives.
  • Assess regulatory implications, risks and opportunities associated with new ingredients, claims, formulations, and market expansion activities.
  • Support development of scalable regulatory strategies for dietary supplements, OTC products and adjacent wellness categories.
  • Monitor and analyze emerging regulatory trends, enforcement priorities, and policy developments across FDA, FTC, Health Canada/NNHPD and related regulatory bodies.
  • Support regulatory assessments and commercialization activities for existing and emerging international markets.
  • Maintain awareness of evolving global regulatory frameworks relevant to dietary supplements, OTC products, botanicals and wellness products.
  • Translate evolving regulatory developments into practice business guidance, risk mitigation strategies, and operations action plans.
  • Develop and recommend regulatory positions and strategies for novel, complex, or higher-risk issues, including documenting the rationale for significant regulatory decisions.
  • Develop practical paths forward where regulatory requirements are uncertain, evolving, or subject to reasonable interpretation rather than defaulting solely to the most conservative regulatory position.
  • Establish and maintain a scalable regulatory governance framework, including clear decision rights, responsibility matrices, escalation pathways, approval processes, regulatory calendars, and mechanisms for tracking regulatory obligations and commitments.
  • Assess the Company's evolving regulatory and compliance operating model and, in partnership with Legal and functional leadership, identify opportunities to clarify, consolidate, or transition regulatory and compliance responsibilities currently distributed across the organization.
Regulatory Affairs & Compliance Coordination
  • Interpret and oversee compliance with current requirements established by government agencies, international regulatory bodies, and third-party standards organizations.
  • Coordinate regulatory and compliance activities associated with marketed products, manufacturing, certifications, logistics/distribution, and related business activities.
  • Support regulatory review activities related to claims, labeling, packaging artwork, advertising, and marketed products.
  • Monitor regulatory developments and translate new or updated requirements into practical business actions and compliance plans.
Cross-Functional Compliance Management
  • Serve as key regulatory leader and advisor across cross functional initiatives
  • Represent regulatory Affairs in cross functional governance processes and operating practices aligned with organizational growth.
  • Influence cross-functional decision making by providing clear, practical regulatory guidance and risk assessment.
  • Coordinate compliance-related documentation, training, monitoring, and audit/inspection readiness activities across functions.
  • Partner with Legal, Quality, Operations, HR, Marketing and Innovation to support adherence to regulatory and certification obligations.
  • Establish scalable regulatory governance processes and operating practices aligned with organizational growth.
Certifications & External Standards
  • Support ongoing compliance with third-party certification requirements, including Organic and Fair for Life.
  • Coordinate certification-related documentation, audits, and cross-functional follow-up activities.
  • Partner with internal stakeholders to support responsible sourcing and manufacturing practices aligned with Company standards and commitments.
Audit & Inspection Readiness
  • Support internal and external audit/inspection readiness activities.
  • Coordinate follow-up actions, documentation requests, and cross-functional preparation efforts.
  • Establish and maintain visibility into compliance obligations, timelines, and required actions.
What This Role Is (and Is Not)
This role is:
  • A broad, enterprise-focused regulatory leadership role requiring strategic judgment, initiative, and cross-functional ownership.
  • The functional leader and primary internal authority for Regulatory Affairs.
  • The owner of the Company's regulatory strategy, operating model, governance, processes, and regulatory capability development.
  • A strategic advisor to senior leaders and cross-functional teams on regulatory risk, opportunities, and business decisions.
  • A builder of scalable regulatory and compliance capabilities appropriate for a growing consumer health business.
  • A leader who identifies regulatory and compliance responsibilities that should be centralized, clarified, or transitioned as the organization evolves.
This role is not:
  • The sole owner of all compliance activities across the enterprise. The role owns the Regulatory Affairs function and designated enterprise compliance programs but operates through a distributed compliance model in which business functions remain accountable for executing requirements within their areas of responsibility.
  • An intra-functional compliance role (e.g. Manufacturing-only compliance).
  • Analogous to the type of highly-specialized Regulatory Affairs functions commonly found in more heavily regulated industries (e.g. pharmaceuticals).
Requirements
  • 7-10+ years of progressively responsible experience in Regulatory Affairs, Compliance, or related areas, in regulated product environments, including experience exercising independent regulatory judgment and leading cross-functional initiatives.
  • Experience in dietary supplements, OTC, botanical, consumer health, food/wellness, or similarly regulated CPG environments; direct dietary supplement and/or OTC experience strongly preferred.
  • Strong cross-functional leadership and project management skills, including the ability to drive initiatives without direct authority.
  • Experience supporting audits, inspections, documentation systems, and compliance processes.
  • Comfort operating in a growing organization where processes are evolving, including the ability to build systems, manage external resources, and create structures where needed.
  • Strong communication skills, including the ability to translate technical regulatory issues into concise business risks, options, and recommendations.

Education:
  • College degree (BA or BS) preferred.
  • Graduate degree a plus.
Why This Role Matters
As Traditional Medicinals grows its manufacturing footprint, product portfolio, certifications, and operational complexity, the Company's regulatory and compliance coordination needs are increasing significantly.
This role will strengthen scalable regulatory and compliance capabilities, support responsible growth, and preserve leadership capacity for higher-order strategic, governance, and legal work.
Salary Range for this position is : $ 155,900.00 - $204,645.00
Physical/Mental Requirements: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
Traditional Medicinals, Inc. and its subsidiaries are proud equal-opportunity employers. We wholeheartedly embrace authenticity, diversity, and people's differences. We acknowledge, celebrate, and support individuality to the great advantage of our consumers, our stakeholders, our products, and the planet. We are committed to building an inclusive workplace for all our people.
We do not discriminate on the basis of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law.

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