Senior Regulatory Affairs Manager - Macpower Digital Assets Edge Private Limited (MDA Edge)
New York, NY 10006
About the Job
Summary:
LG H&H USA / The client is a leading company in lifestyle and culture that helps our customers realize their beauty and dreams. We share our core values Beautiful, Healthy, and Refreshing with our customers. As a creative consumer marketing company, we go beyond the boundaries of conventional household goods and cosmetics to introduce creative products and services based on our customers' needs.
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:
LG H&H USA / The client is a leading company in lifestyle and culture that helps our customers realize their beauty and dreams. We share our core values Beautiful, Healthy, and Refreshing with our customers. As a creative consumer marketing company, we go beyond the boundaries of conventional household goods and cosmetics to introduce creative products and services based on our customers' needs.
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
- Responsible for US regulatory submissions, including FDA drug and establishment registrations, supplement notifications, WERCS and EPA and state pesticide registrations
- Assist monitoring US state and federal regulations impacting the cosmetic and personal care industry including OTC
- Support with upcoming changes in the regulations including any specific monitoring and implementation for states, e.g., California.
Preferred Qualifications:
- Onsite 3 days per week
- 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).
Source : Macpower Digital Assets Edge Private Limited (MDA Edge)