Hybrid Regulatory Compliance Specialist - Global Markets

Cymbiotika LLC; San Diego (CA); Hybrid; USD 110,000 - 125,000; Full time

Benefits offered by this job

Medical, dental, and vision coverage

401(k) with company match

Paid holidays and PTO

Job summary

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.

Qualifications

• 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.

Responsibilities

• 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.

Skills

Regulatory affairs

Regulatory compliance

FDA regulations

Cross-functional collaboration

Job description

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.