Senior Regulatory Affairs Manager

Macpower Digital Assets Edge Private Limited

New York, NY

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JOB DETAILS

SALARY

$90,000–$140,000 Per Year

SKILLS

Advertising, Analysis Skills, Communication Skills, Consumer Advertising, Consumer Marketing, Cross-Functional, Current Good Manufacturing Practice (cGMP), Customer Support/Service, Detail Oriented, Documentation, Environmental Protection Agency (EPA), FDA (Food and Drug Administration), Federal Laws and Regulations, Health Canada, ISO (International Organization for Standardization), Korean Language, Maintain Compliance, Microsoft Excel, Microsoft Office, Microsoft Outlook, Microsoft PowerPoint, Microsoft Word, Organizational Skills, Personal Care, Product Development, Product Reviews, Regulations, Regulatory Compliance, Regulatory Requirements, Sales Presentation, Skin Care, State Laws and Regulations, Time Management, Usability Engineering, Writing Skills

LOCATION

New York, NY

POSTED

14 days ago

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:

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).

Senior Regulatory Affairs Manager

Macpower Digital Assets Edge Private Limited

New York, NY

About the Company

Macpower Digital Assets Edge Private Limited

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