Regulatory Affairs Specialist

Regulatory Affairs Specialist

Regulatory Affairs Specialist Location: Tarrytown, NY Position Type: Permanent Work Arrangement: Hybrid 3 days onsite and 2 days remote Position Overview The Regulatory Affairs Specialist will take a hands-on role in domestic and international regulatory compliance for cosmetics, OTC drugs, and other consumer health products. Responsibilities include preparing regulatory dossiers, registering products, reviewing labels, supporting market entry and importation, and responding to regulatory inquiries. The specialist will work closely with cross-functional teams to support product development and commercialization while monitoring evolving regulations.

Key Responsibilities

• Create and maintain product dossiers and regulatory documentation for health authorities in applicable markets.
• Manage product registration, listing, and notification activities in the United States, Canada, Latin America, Asia, the EU, and ASEAN markets.
• Support U.S. cosmetic product and facility registration and product listing through FDA Cosmetics Direct.
• Prepare and manage Health Canada cosmetic notifications and applicable OTC drug listings.
• Review product labels for compliance with U.S. and international requirements, including applicable state-level regulations.
• Assess OTC products under applicable FDA monographs and support compliance with relevant U.S. requirements, including 21 CFR Parts 210 and 211.
• Support regulatory requirements for products such as shampoo, body lotion, color cosmetics, and hair color.
• Partner with Product Development, Marketing, Package Development, Claims Support, Quality Assurance, and Purchasing on regulatory processes and commercialization projects.
• Respond to regulatory inquiries from internal business partners and external distributors and retailers.
• Support market importation and retail requirements for products in applicable regions.
• Monitor regulatory developments and communicate relevant changes and requirements to stakeholders.
• Participate in trade association committees and relevant working groups to stay informed and represent the organization.

Required Qualifications

• Bachelor's degree in Chemistry or a life science discipline, such as Biology or Biochemistry. Two to four years of related regulatory affairs experience preferred.
• Experience in a global regulatory environment and familiarity with U.S. FDA and European cosmetic and OTC regulations.
• Knowledge of product registration, dossier preparation, labeling review, and market-entry requirements.

Preferred Qualifications

• Experience in cosmetics, medical devices, OTC drugs, consumer healthcare, or related product sectors; cosmetics experience is especially valued.
• Experience with Canada notifications and requirements for bringing products to market internationally.
• Familiarity with GMP and quality requirements.
• Awareness of U.S. OTC compliance requirements, including FDA OTC monographs and 21 CFR Parts 210 and 211.
• Experience supporting FDA audits or interacting with regulatory authorities.
• OTC medical device experience.
• Hair color product experience.