Cosmetics Regulatory Lead - Global Compliance & Market Access

SIGAN AMERICA, LLC

Ottawa (IL)

On-site

USD 80,000 - 110,000

Full time

4 days ago
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Job summary

SIGAN AMERICA, LLC is seeking a Regulatory Affairs Specialist to drive compliance across cosmetic, personal care, and OTC products. The role collaborates with R&D, Quality, Operations, Marketing, and Commercial teams to ensure regulatory requirements are met while enabling rapid market access.

The successful candidate will manage regulatory documentation, registrations, labeling reviews, compliance assessments, and regulatory intelligence for U.S. and international markets.

Qualifications

  • Bachelor's degree in a scientific field and 2–4 years in Regulatory Affairs within cosmetics, personal care, OTCs or related sectors.
  • Experience with FDA cosmetic and OTC drug regulations, cGMP, Health Canada, EU Cosmetics Regulation.
  • Experience with label reviews, claims substantiation, and maintaining regulatory documentation.
  • MoCRA compliance, cosmetic facility/product registration, OTC Drug Facts labeling, and EU CPNP/FM requirements.

Responsibilities

  • Provide regulatory guidance for new product development, reformulations, changes, and market expansions.
  • Collaborate with cross-functional teams to ensure regulatory compliance of ingredients, labels, claims, and marketing materials.
  • Prepare, review, and maintain regulatory documentation including ingredient listings, formulas, SDSs, registrations, and submissions.
  • Conduct label and claims reviews to ensure FDA, Health Canada, EU, and international compliance.
  • Maintain regulatory files to support audits, inspections, and inquiries.
  • Monitor regulatory developments and advise on impact and compliance strategies.
  • Support global registrations and regulatory submissions as needed.
  • Partner with R&D to establish formulation guidelines for global access.

Skills

Regulatory knowledge
Analytical thinking
Project management
Verbal and written communication

Education

Bachelor's degree in Chemistry, Biology, Regulatory Science, Pharmaceutical Sciences, or related

Tools

MS Office (Word, Excel, PowerPoint, Access)

Job description

SIGAN AMERICA, LLC is seeking a Regulatory Affairs Specialist to drive compliance across cosmetic, personal care, and OTC products. The role collaborates with R&D, Quality, Operations, Marketing, and Commercial teams to ensure regulatory requirements are met while enabling rapid market access.

The successful candidate will manage regulatory documentation, registrations, labeling reviews, compliance assessments, and regulatory intelligence for U.S. and international markets.

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