Senior Regulatory Affairs Manager

About the role

The Senior Regulatory Affairs Manager ensures regulatory compliance of The client / LG H&H US cosmetic, OTC, dietary supplement, and device products from brief through launch in North America. Specifically, the Sr. Manager will assemble and review all product-related information including formulas, specifications, and quality/regulatory compliance documentation, and for approving claims, labeling, and advertising. Communicate emerging regulations to key stakeholders and their impact on The Avon/LG H&H US portfolio.

Roles & Responsibilities

• Participate in project teams in assigned categories to ensure completion of appropriate documents during the development process through final formula approval and launch
• Maintain and ensure compliance with The client ingredient policies and appropriate product regulations
• Ensure claims are compliant with The client and local regulatory requirements and consistent across labels, advertising, and other consumer communications
• Review and approve NA artworks
• For US regulatory submissions, including FDA drug and establishment registrations, supplement notifications, WERCS and EPA and state pesticide registrations
• Aid in US regulatory submissions, including FDA drug and establishment registrations, supplement notifications, WERCS and EPA and state pesticide registrations
• Absorb and communicate emerging regulations to key stakeholders and their impact on The Avon/LG H&H US portfolio
• Support with upcoming changes in the regulations including any specific monitoring and implementation for states, e.g., California

Preferred Qualifications

• Bilingual English/Korean preferred

Minimum Qualifications

• Scientific degree
• Over 8 years of Regulatory Affairs experience within a regulated industry, preferably skin and personal care products including OTC
• Product development experience strongly preferred
• Skin and personal care including OTC claim review experience strongly preferred
• Track record adhering to compliance requirements (i.e. FDA, Health Canada, EPA, FTC, cGMP, ISO, etc.)
• Strong written communication skills, especially detail oriented and technical material
• Experience communicating with cross-functional teams and customers including verbal presentations
• Ability to work effectively both independently and as part of a team
• Ability to meet deadlines while being flexible to changes in priorities and interruptions
• Excellent organizational and analytical skills to complete assignments accurately
• Full usability of MS Office suite (Excel, Word, Outlook, PowerPoint)