Regulatory Affairs Director
4 weeks ago
At LVMH Perfumes & Cosmetics, we are seeking a highly skilled Regulatory Affairs Director to lead our operational regulatory affairs team on cosmetics and OTC drugs for the USA and Canada. This role will be the primary contact to various governmental agencies in the USA and Canada, requiring a deep understanding of regulatory implications in gaining and maintaining market access.
Key Responsibilities:
- Fluent knowledge of cosmetic and OTC drug business, and regulatory implications in gaining and maintaining market access in the USA and Canada.
- Identifying and actioning opportunities on operational regulatory affairs topics to drive our Beauty business on cosmetic and OTC drug regulations.
- Demonstrate broad business thinking, routinely monitors, and keeps current on competitive market trends, competitor and health authority activity to identify opportunities and risk to assigned business areas.
- Working with Strategy and Advocacy regulatory team to evaluate operational impact specific to LVMH Beauty Maison's for the regulatory evolution in the USA and Canada on notifications, registrations or labeling and sharing information within the Group.
- Lead on operational questions linked to regulations of cosmetics and OTC drugs.
- Strong leadership and ability to drive process internally on how to prepare, submit, maintain records, and produce KPI's for USA and Canada for the following:
- prior to product launch (MoCRA, CNF, CA Safe Cosmetic Act, children's products etc.)
- annual notification if needed (VOC, packaging/extended producer responsibility, CARB, and any other states)
- OTC establishment registration, drug listing, blanket no change with FDA
- DIN/NHP registration with Health Canada
Requirements:
- Professional experience in Chemistry, Chemical Engineering, Legal or related science
- 10 years of Cosmetic Regulatory Affairs experience
- 5 years of demonstrated people-management experience
- Strong computer skills (PowerPoint and MS Excel)
- Fluent knowledge of USA and Canada cosmetic regulations
- Fluent knowledge of USA and Canada drug regulations
- Fluency or working knowledge of French is a plus
Working Conditions:
This position is full-time and hybrid, with 3 days per week at our East Brunswick, NJ office. LVMH Inc. uses the published salary range as a guideline to provide our employees with market competitive pay while allowing for flexibility to recognize and reward various levels of expertise, performance and tenure.
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