Regulatory Compliance Specialist

Cymbiotika LLC; San Diego (CA); Hybrid; USD 110.000 - 125.000; Vollzeit

Benefits dieser Stelle

Medical, dental, and vision coverage

401(k) with company match

Paid holidays and PTO

Zusammenfassung

Cymbiotika LLC is seeking an experienced Regulatory Compliance Specialist to support product compliance across dietary supplements, foods, cosmetics, and international markets. You will ensure labeling, manufacturing, and marketing meet FDA and global requirements, collaborating with Legal, Product Development, Quality, and Marketing.

The ideal candidate has 4+ years in regulatory affairs, strong knowledge of FDA 21 CFR parts 110, 111, 117, and experience with international registrations.

Qualifikationen

• 4+ years of Regulatory Affairs or Regulatory Compliance experience.
• Strong knowledge of FDA 21 CFR Parts 110, 111, and 117, FD&C Act, Prop 65, and Health Canada requirements.
• Experience reviewing formulas, ingredients, labels, and claims.
• Experience supporting international regulatory requirements, including Health Canada.

Aufgaben

• Support regulatory compliance for dietary supplements, foods, cosmetics, and related products across markets.
• Review product labels, packaging, and documentation to ensure regulatory compliance.
• Collaborate with Marketing, Product Development, Legal, and Quality teams on labeling and claims.
• Maintain regulatory files, certifications, and documentation; manage regulatory reporting efforts.
• Develop and update regulatory SOPs and tracking systems; assist with audits and inspections.

Kenntnisse

Regulatory affairs

Regulatory compliance

FDA regulations

Cross-functional collaboration

Jobbeschreibung

About Cymbiotika

At Cymbiotika, we believe that wellness starts with trust. That’s why we’re committed to creating supplements that are not only effective but also transparent. From the moment you pick up one of our products, you’ll know exactly what’s inside—no hidden ingredients, no confusing labels. We take pride in using only the highest-quality ingredients, carefully sourced and backed by science, to ensure you’re getting the best of nature and innovation in every supplement.

We understand that health is personal, which is why our supplements are designed to work with your body, not against it. By focusing on bioavailability and using advanced liposomal delivery systems, we ensure that your body can absorb and use the nutrients to their fullest potential. Our goal is simple: to help you feel your best, with products you can trust, made with ingredients you feel good about.

With Cymbiotika, you’re not just taking a supplement—you’re joining a community of people who value wellness, science, and the power of transparency. We’re here to empower you on your journey to better health, every step of the way.

Role Overview

Cymbiotika is seeking an experienced Regulatory Compliance Specialist to support product compliance and regulatory initiatives across dietary supplements, nutritional products, foods, and cosmetics. This role will help ensure products are manufactured, labeled, and marketed in compliance with applicable U.S. and international regulations, including 21 CFR Parts 111, 117, and 110, the FD&C Act, and the Fair Packaging and Labeling Act.

The Specialist will support regulatory assessments, product and label compliance, registrations, certificates, inspections, recalls, consumer complaints, and other regulatory programs. This role will collaborate cross-functionally with Legal, Product Development, R&D, Quality, and other teams to provide practical regulatory guidance and support Cymbiotika’s continued growth and international expansion.

The ideal candidate brings experience with regulatory compliance in the dietary supplement, food, cosmetics, or consumer products industry and strong communication and cross-functional collaboration skills.

Key Responsibilities

Regulatory Compliance & Product Assessment

• Support regulatory compliance for dietary supplements, nutritional products, foods, and cosmetics, including applicable FDA regulations under21 CFR Parts 110, 111, and 117, the Federal Food, Drug, and Cosmetic Act, Fair Packaging and Labeling Act, Prop 65, and applicable international regulations.
• Conduct preliminary regulatory assessments of formulas, ingredients, finished products, and product innovations to identify potential compliance considerations.
• Review formulas, raw materials, finished product specifications, and applicable regulatory requirements to support product compliance.
• Monitor regulatory changes, guidance, standards, and industry best practices and communicate relevant updates to internal stakeholders.

Labeling & Marketing Compliance

• Review new and revised product labels, packaging, artwork, and supporting documentation to ensure compliance with applicable regulatory requirements.
• Collaborate with Marketing and Product Development to review product claims, labeling, and consumer-facing materials.
• Provide regulatory guidance on product positioning, claims, and labeling throughout the product lifecycle.

International Registrations & Regulatory Documentation

• Support product registrations, notifications, certificates, and other regulatory submissions for applicable international markets, including Health Canada, UAE, and the UK.
• Maintain regulatory files, product documentation, certifications, specifications, and other compliance records.
• Manage and coordinate required regulatory reporting, including annual and periodic reporting

Vendor & Manufacturing Compliance

• Coordinate with third-party manufacturers, testing laboratories, and vendor partners to obtain and maintain required regulatory documentation.
• Support product testing requirements, facility certifications, audits, GMP, ISO, and other applicable compliance requirements.
• Build strong working relationships with third-party manufacturers and testing facilities to support ongoing product compliance.

Regulatory Programs & Process Management

• Develop, maintain, and update regulatory SOPs, processes, and documentation to support company policies and applicable regulations.
• Maintain systems for tracking regulatory requirements, changes, and updates.
• Support regulatory responses and documentation related to audits, inspections, recalls, complaints, and other compliance matters.
• Support regulatory strategy for assigned projects by identifying potential regulatory requirements, risks, and considerations.
• Collaborate with internal and external regulatory counsel as needed.
• Identify emerging regulatory trends and communicate potential impacts and proactive compliance considerations to internal stakeholders.

Additional Duties:

Perform other related duties, responsibilities, and special projects as assigned based on business needs and organizational priorities.

Qualifications

• 4+ years of Regulatory Affairs or Regulatory Compliance experience, preferably within the dietary supplement, nutritional, food, or consumer products industry.
• Strong knowledge of FDA 21 CFR Parts 110, 111, and 117, FPLA, FD&C Act, Prop 65, and applicable Health Canada requirements.
• Experience with formula, ingredient, label, and claims review.
• Experience supporting international regulatory requirements, including Health Canada.
• Experience developing and implementing regulatory SOPs and compliance processes.
• Strong attention to detail and ability to collaborate cross-functionally with R&D, Quality, Legal, Marketing, and external partners.

Nice to Have / Preferred Qualifications

• Self-motivated, able to manage multiple projects, and know how to prioritize. Does not have to wait for directions,
• Must have experience working in start up like culture in a fast-paced environment
• Excellent team player with a demonstrated ability to successfully participate in cross-functional teams, with the ability to summarize and communicate risk and technical details in a business-friendly way.
• Ability to communicate effectively, orally and in writing, with leadership, employees and all other internal and external contacts.
• Strong attention to detail and a proven ability in managing time and tasks associated with fast-paced organization.
• Ability to demonstrate accuracy and thoroughness, looking for ways to improve processes and procedures.
• Ability to think strategically and be extremely detail oriented.
• Demonstrated proficiency in Google Workspace, MS Office Suite, and ideally, NetSuite.

Work Location & Schedule

This position follows an enforced hybrid schedule, requiring team members to be present in our San Diego, California office at least four days per week (Monday–Thursday). Fridays are available for remote work. This role also requires attendance at all in-person monthly team meetings and quarterly company events.

Physical Requirements

This role primarily involves office-based work and requires the ability to occasionally lift, carry, or move items up to 20–30 pounds, such as files or office supplies. Employees should be able to sit or stand for extended periods and perform frequent computer-based tasks, including prolonged exposure to a computer screen.

Compensation & Total Rewards

The salary range for this position is $110,000 - 125,000 annually. Final compensation will be determined based on experience, skills, and qualifications relevant to the role.

Cymbiotika offers a comprehensive total rewards package designed to support employee wellness, growth, and work-life balance. Benefits include medical, dental, and vision coverage with employer-paid plan options, 401(k) with company match, paid holidays and PTO, flexible work-from-home Fridays, wellness and fitness perks, employee product discounts, catered team lunches, team-building events, and additional lifestyle benefits!