Regulatory Affairs Specialist

Sigan America LLC; Ottawa (IL); Presencial; USD 70.000 - 100.000; Jornada completa

Descripción de la vacante

Sigan America LLC in Ottawa, IL is seeking a Regulatory Affairs Specialist to support compliance across cosmetic, personal care, and OTC drug products. You will partner with R&D, Quality, Operations, and Marketing to ensure regulatory requirements are met and to accelerate speed to market.

The role focuses on managing regulatory documentation, product registrations, label and claims reviews, and regulatory intelligence for the U.S. and international markets.

Formación

• Bachelor's degree in a scientific field is required.
• 2–4 years of Regulatory Affairs experience in cosmetics, personal care, OTC pharmaceuticals, or related industries.
• Experience with FDA cosmetic and OTC drug regulations, cGMP, Health Canada, EU Cosmetic Regulation, and MoCRA.

Responsabilidades

• Provide regulatory guidance for new product development, reformulations, product changes, and market expansions.
• Collaborate with R&D, Quality, Operations, and Marketing to ensure regulatory compliance of products, ingredients, labels, and claims.
• Prepare, review, and maintain regulatory documentation, including ingredient listings, formulas, product registrations, and safety documentation.
• Conduct label and claims reviews to ensure compliance with FDA, Health Canada, EU, state, and international requirements.
• Support global product registrations and regulatory submissions; develop regulatory processes and provide internal training.

Conocimientos

Regulatory knowledge

Documentation management

Cross-functional collaboration

Attention to detail

Project management

Verbal and written communication

Microsoft Office

Educación

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

Descripción del empleo

Job Description

Regulatory Affairs Specialist

Department: Regulatory Affairs
Location: Ottawa, IL 61350
Schedule: Full-Time | First Shift

Position Summary

We are seeking a Regulatory Affairs Specialist to support and drive compliance across our portfolio of cosmetic, personal care, and OTC drug products. This role serves as a key partner to R&D, Quality, Operations, Marketing, and Commercial teams, ensuring products meet regulatory requirements while supporting innovation and speed to market.

The successful candidate will manage regulatory documentation, product registrations, label and claims reviews, compliance assessments, and regulatory intelligence activities for U.S. and international markets. This position requires a strong understanding of cosmetic and OTC regulations, excellent communication skills, and the ability to translate complex regulatory requirements into practical business solutions.

Key Responsibilities

• Provide regulatory guidance and support for new product development, reformulations, product changes, and market expansions.
• Collaborate with cross-functional teams to ensure products, ingredients, labels, claims, and marketing materials comply with applicable regulations.
• Prepare, review, and maintain regulatory documentation, including:
• • Ingredient listings
  • Quantitative formulas
  • Cosmetic compliance documentation
  • Product registrations and notifications
  • Claims support packages
  • Safety and technical documentation
• Conduct label and claims reviews to ensure compliance with FDA, Health Canada, EU, state, and international regulatory requirements.
• Maintain regulatory files and documentation supporting audits, inspections, customer inquiries, and legal challenges.
• Monitor emerging regulations and industry developments, assessing business impact and recommending compliance strategies.
• Support global product registrations and regulatory submissions as required.
• Partner with R&D to establish formulation and ingredient guidelines that support global market access.
• Assist in developing and implementing regulatory processes, procedures, and best practices across the organization.
• Provide regulatory training and guidance to internal stakeholders.
• Support compliance initiatives related to retailer standards, customer requirements, NGO programs, and sustainability certifications.
• Participate in investigations, change control activities, and risk assessments related to regulatory compliance.

Required Qualifications

• Bachelor's degree in Chemistry, Biology, Regulatory Science, Pharmaceutical Sciences, or a related scientific discipline.
• 2–4 years of Regulatory Affairs experience within cosmetics, personal care, OTC pharmaceuticals, or related regulated industries.
• Strong working knowledge of:
• • FDA cosmetic regulations
  • FDA OTC drug regulations
  • cGMP requirements
  • Health Canada regulations
  • EU Cosmetic Regulation
• Experience conducting label reviews and claims substantiation assessments.
• Experience preparing and maintaining regulatory documentation and technical files.
• Experience with MoCRA compliance and cosmetic facility/product registration.
• Experience with OTC Drug Facts labeling and monograph compliance.
• Experience with PIF preparation, CPNP notifications, and EU Responsible Person requirements.
• Experience supporting Target Clean, Walmart Clean, Sephora Clean, Ulta Clean, Amazon, and retailer-specific ingredient standards.
• Familiarity with IFRA, allergen disclosures, Prop 65, VOC regulations, and sustainability certifications
• Knowledge of state-level regulatory requirements, including California Proposition 65.
• Experience authoring and maintaining Safety Data Sheets (SDSs).
• Excellent verbal, written, organizational, and project management skills.
• Strong analytical and problem-solving abilities with attention to detail.
• Advanced proficiency with Microsoft Office applications, including Word, Excel, PowerPoint, and Access.

Preferred Qualifications

• Experience supporting international product registrations and market compliance activities.
• Familiarity with retailer and customer compliance programs.
• Understanding of NGO and certification requirements, including Non-GMO Project, vegan, sustainability, and clean beauty initiatives.
• Experience supporting regulatory audits and customer compliance reviews.
• Working knowledge of statistical analysis and data interpretation.

Key Competencies

• Regulatory judgment and risk assessment
• Critical thinking and problem solving
• Project management and prioritization
• Technical writing and documentation
• Cross-functional collaboration
• Communication and influence
• Attention to detail
• Adaptability in a changing regulatory environment

Why Join Us?

• Influence the development and launch of innovative cosmetic, personal care, and OTC products.
• Work directly with R&D, Quality, Operations, and Commercial teams.
• Gain exposure to U.S. and global regulatory environments.
• Play a critical role in protecting product compliance, enabling market access, and supporting business growth.

Company Description

About Us
Fast growing liquid pour contract manufacturer of premium health and beauty products.

Company Description

About UsFast growing liquid pour contract manufacturer of premium health and beauty products.