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Regulatory Affairs Manager Jobs (NOW HIRING)

Daikin

Regulatory Affairs Manager

Santa Clara, CA

$120K - $145K/yr

The Regulatory Affairs Manager is responsible for monitoring, interpreting, and influencing regulatory and standards requirements that impact HVAC products and systems within the West Coast region ...

Jj

Regulatory Affairs Manager

Raynham, MA

Provide Regulatory Affairs support during internal and external audits * Responsible for communicating business related issues or opportunities to next management level * Responsible for following ...

Daikin

Regulatory Affairs Manager

Santa Clara, CA · On-site

$120K - $145K/yr

The Regulatory Affairs Manager is responsible for monitoring, interpreting, and influencing regulatory and standards requirements that impact HVAC products and systems within the West Coast region ...

Daikin

Regulatory Affairs Manager

Santa Clara, CA

$120K - $145K/yr

The Regulatory Affairs Manager is responsible for monitoring, interpreting, and influencing regulatory and standards requirements that impact HVAC products and systems within the West Coast region ...

McKesson

Regulatory Affairs Manager

Los Angeles, CA

$85K - $141K/yr

We are seeking a Regulatory Affairs Manager. We are seeking a Regulatory Affairs Manager. This is a remote, work-from-home position, preferably based in the Dallas-Fort Worth Metroplex, Texas. Other ...

McKesson

Regulatory Affairs Manager

Concord, NC

$85K - $141K/yr

We are seeking a Regulatory Affairs Manager. We are seeking a Regulatory Affairs Manager. This is a remote, work-from-home position, preferably based in the Dallas-Fort Worth Metroplex, Texas. Other ...

Dentsply Sirona

Regulatory Affairs Manager

The primary job responsibility for of the Regulatory Affairs Manager is overseeing the day-to-day functions of the Dentsply Sirona Implants and Prosthetics team. This role develops regulatory ...

Jj

Regulatory Affairs Manager

West Chester, PA

Provide Regulatory Affairs support during internal and external audits * Responsible for communicating business related issues or opportunities to next management level * Responsible for following ...

Jj

Regulatory Affairs Manager

Palm Beach Gardens, FL

Provide Regulatory Affairs support during internal and external audits * Responsible for communicating business related issues or opportunities to next management level * Responsible for following ...

McKesson

Regulatory Affairs Manager

Concord, NC

$85K - $141K/yr

We are seeking a Regulatory Affairs Manager. We are seeking a Regulatory Affairs Manager. This is a remote, work-from-home position, preferably based in the Dallas-Fort Worth Metroplex, Texas. Other ...

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How much do regulatory affairs manager jobs pay per hour?

As of Jul 30, 2026, the average hourly pay for regulatory affairs manager in the United States is $56.97, according to ZipRecruiter salary data. Most workers in this role earn between $42.07 and $66.59 per hour, depending on experience, location, and employer.

What does a Regulatory Affairs Manager do?

A Regulatory Affairs Manager oversees the process of ensuring that a company’s products comply with all regulations and laws applicable to their industry, such as pharmaceuticals, medical devices, or food. They coordinate the preparation and submission of regulatory documents to government agencies and serve as a liaison between the company and regulatory authorities. Their role includes monitoring changes in regulations, developing strategies for approval, and ensuring ongoing compliance throughout the product lifecycle.

What are the key skills and qualifications needed to thrive as a Regulatory Affairs Manager, and why are they important?

To thrive as a Regulatory Affairs Manager, you need a comprehensive understanding of regulatory guidelines, scientific or technical expertise, and typically a degree in life sciences or a related field. Experience with submission management systems, regulatory databases, and knowledge of global regulatory frameworks (such as FDA, EMA, or ICH) are highly valuable. Strong attention to detail, communication skills, and the ability to manage cross-functional teams distinguish top performers in this role. These competencies are crucial for ensuring product compliance, minimizing approval risks, and facilitating smooth market entry.

What are some common challenges faced by Regulatory Affairs Managers when working with cross-functional teams?

Regulatory Affairs Managers often encounter challenges in aligning regulatory requirements with the goals of other departments, such as R&D, marketing, and manufacturing. Navigating differing priorities and timelines can be complex, especially when ensuring compliance without delaying product development. Effective communication and negotiation skills are essential to bridge gaps between teams, clarify regulatory expectations, and facilitate smooth collaboration. By proactively engaging stakeholders and providing regulatory guidance early in projects, Regulatory Affairs Managers can help teams work together more efficiently and avoid costly compliance issues.

What Does a Regulatory Affairs Manager Do?

As a regulatory affairs manager, your responsibilities entail ensuring that your employer observes all relevant laws and regulations. You can find employment in various sectors, including pharmaceutical, healthcare, and manufacturing industries. Your duties include compiling all necessary paperwork, evidence, and documentation to report to regulatory authorities. In addition to the management of paperwork and legal requirements, you help companies make operational and strategic decisions based on the regulations they are obligated to follow. You sometimes perform or coordinate audits to ensure compliance, and, in a large company, you oversee a staff of compliance specialists who handle various regulatory affairs tasks.

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

AspectRegulatory Affairs ManagerRegulatory Affairs Specialist
CredentialsBachelor's degree, often advanced certifications (e.g., RAC)Bachelor's degree, entry-level certifications
Work EnvironmentOversees teams, strategic planning, cross-department collaborationExecutes regulatory submissions, document preparation, detailed compliance tasks
Industry UsageUsed in pharmaceutical, biotech, medical device companies for leadership rolesCommonly found in similar industries, focusing on technical regulatory tasks
Search & Comparison IntentUnderstanding managerial responsibilities and scopeFocus on specific regulatory tasks and compliance details

The Regulatory Affairs Manager typically holds a leadership role, overseeing regulatory strategies and teams, while the Regulatory Affairs Specialist handles detailed compliance work and documentation. Both roles require relevant certifications and are essential in regulated industries like pharma and medical devices.

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Regulatory Affairs Manager jobs near you
Infographic showing various Regulatory Affairs Manager job openings in the United States as of July 2026, with employment types broken down into 72% Full Time, 25% Part Time, 1% Temporary, and 2% Contract. Highlights an 75% Physical, 2% Hybrid, and 23% Remote job distribution, with an average salary of $118,493 per year, or $57 per hour.

Regulatory Affairs Manager

Huisong Pharmaceuticals

Santa Ana, CA • On-site

$38 - $48/hr

Part-time

Re-posted 12 days ago

Job description

Regulatory Affairs Manager
Company: Huisong Inc.
Location: Santa Ana, California, Orange County
Schedule: Part-time, approximately 10 hours per week
Work Arrangement: On-site
About Huisong Inc.
Huisong Inc., located in Santa Ana, California, is the U.S. office of Huisong Pharmaceuticals. Founded in 1998, Huisong Pharmaceuticals specializes in the research, development, and manufacturing of premium-quality natural ingredients for leading companies in the pharmaceutical, nutraceutical, food and beverage, and personal care industries. Today, Huisong Pharmaceuticals operates globally and offers an extensive portfolio of natural products and ingredients. Guided by its core values of Nature, Health, and Science, Huisong continues to advance medicine and nutrition in support of health and well-being worldwide.
Official Company Website: https://www.huisongpharm.com/
Position Overview
Huisong Inc. is seeking an experienced Regulatory Affairs Manager to support regulatory strategy and compliance for dietary supplements, botanical ingredients, herbal extracts, and Traditional Chinese Medicine products.
The Regulatory Affairs Manager will support the U.S. business while collaborating with Huisong’s corporate office, global teams, suppliers, and business partners.
Key Responsibilities:
  • Develop and implement regulatory strategies for new and existing products, including dietary supplements, herbal extracts, botanical ingredients, and Traditional Chinese Medicine products.
  • Lead or support FDA submissions and regulatory pathways, including New Dietary Ingredient Notifications, GRAS determinations, and applicable OTC monograph requirements.
  • Support international product registrations, including EU Novel Food applications and Health Canada Natural Health Product registrations.
  • Advise senior management on new and emerging regulations, including FDA updates, California Proposition 65, FSMA, and international regulatory developments.
  • Ensure compliance with applicable current Good Manufacturing Practices, including 21 CFR Parts 111 and 117, ISO 9001 standards, and USDA and EU organic certification requirements.
  • Manage FDA, NSF, customer, and third-party regulatory audits and oversee corrective and preventive actions.
  • Review product labels, marketing materials, and product claims for compliance with FDA and FTC requirements, including structure/function claims and Traditional Chinese Medicine disclosures.
  • Collaborate with Research and Development, Sales, Quality, and Supply Chain teams to align regulatory requirements with business goals.
  • Work with global suppliers to ensure raw material compliance, including ingredient identity, adulteration testing, heavy metal limits, pesticide limits, and supporting documentation.
  • Navigate regulations and standards specific to botanicals and Traditional Chinese Medicine, including the USP Herbal Medicines Compendium, World Health Organization guidance, and China NMPA standards.
  • Address regulatory matters involving botanical adulteration, safety data, ingredient identity, and traditional-use claims.

Education and Experience Requirements:
  • Bachelor’s degree or equivalent education in pharmacy, chemistry, food science, herbal medicine, regulatory affairs, or a related scientific field.
  • At least five years of regulatory affairs experience within the nutraceutical, dietary supplement, botanical, herbal medicine, or Traditional Chinese Medicine industries.
  • Strong working knowledge of:
    • FDA 21 CFR Parts 111 and 117
    • Dietary Supplement Health and Education Act
    • New Dietary Ingredient Notifications
    • GRAS requirements
    • Current Good Manufacturing Practices
    • ISO 9001
    • Foreign Supplier Verification Programs
    • U.S. and international dietary supplement regulations
  • Preventive Controls Qualified Individual certification is required.
  • HACCP certification or related food-safety training is preferred.
  • Regulatory Affairs Certification is a plus.

Additional Qualifications:
  • Experience managing FDA, customer, or third-party certification audits.
  • Experience working with international suppliers and corporate teams.
  • Strong analytical, communication, organizational, and documentation skills.
  • Ability to interpret complex regulatory requirements and provide practical guidance to leadership and cross-functional teams.
  • Ability to work independently and manage priorities within a part-time schedule.