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Manager, Regulatory Affairs

LVMH Perfumes & Cosmetics

Manager, Regulatory Affairs

National
Full Time
Paid
  • Responsibilities

    Job Description

    For the LVMH Perfume and Cosmetics scope of brands, joining the Regulatory Affairs & External Relations team to lead and perform the submission of cosmetics and OTC drugs to various governmental agencies in the USA and Canada. This position will also be the Quality Assurance expert for new laws and regulations pertaining to GMPs and to fully support any governmental Audit for North America. They will also be the lead on key scientific topics linked to Green Chemistry.

    • Leading a team of individual contributors (2)
    • Position is full time
    • Position is hybrid
    • Position may require up to 15% domestic and/or international travel

    PRINCIPAL DUTIES AND RESPONSIBILITIES

    For LVMH Perfumes & Cosmetics scope of brands…

    REGULATORY AFFAIRS (PRIMARY FUNCTION):

    • Streamline processes internally on how to prepare, submit, and maintain records for USA and Canada on the following:
      • prior to product launch (VCRP, 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
    • Working with Strategy and Advocacy regulatory team to evaluate operational impact specific to LVMH P&C Maison’s for the regulatory evolution in the USA and Canada on notifications, registrations or labeling and sharing within the Group/Scientific Direction. Creating a proposal and ensuring followed.
    • Lead expert on green chemistry (Prop 65, DTSC, CARB, ECCC)
    • FDA CPB facing as needed

    QUALITY ASSURANCE (SECONDARY FUNCTION):

    • Quality Assurance lead on governmental changes to GMPs
    • Lead support of Governmental audits

    OVERALL:

    • Direct, coach and train individual contributors
    • Prepare and update regulatory procedures like SOPs and Work Instructions
    • Prepare and present topics to Group/Scientific Direction partners as needed

    SUPERVISION RECEIVED

    Reports to Vice President, Regulatory Affairs & External Relations

    SUPERVISION EXERCISED

    (2) Individual contributors (eventually)

    ORGANIZATIONAL STRUCTURE: INTERNAL INTERFACE

    • Scientific Direction LVMH Research
    • Brands HQ Operational Regulatory Affairs department,
    • North America Brands Marketing,
    • Legal team (LVMH Inc, LVMH P&C)
    • Operations & Finance teams
    • Corporate Affairs (LVMH Holding)

    ORGANIZATIONAL STRUCTURE: EXTERNAL INTERFACE

    • Trade Associations (PCPC, Cosmetic Alliance Canada, Fragrance Creators Association)
    • Authorities (FDA, FTC, Health Canada, Environment Canada, various State agencies)
  • Qualifications

    Qualifications

    • Skills
      • Ability to interpret applicable regulations
      • Ability to think and execute of creative solutions to complex regulatory/quality issues
      • Detail oriented, strong organizational skills, multi-tasking ability, process driven, highly collaborative
      • Ability to meet governmental deadlines
      • High accuracy and reliability on assigned tasks
      • Ability to work to foster a team environment while being able to prioritize work
    • Qualifications
      • Professional experience in Chemistry, Chemical Engineering, or related science
      • 7 years of Cosmetic Regulatory Affairs experience
      • 3 years of Quality Assurance experience
      • 2 years of demonstrated people-management experience
      • Strong computer skills (PowerPoint and MS Excel)
      • Very strong understanding and knowledge of USA and Canada cosmetic regulations
      • Strong understanding and knowledge of USA and Canada drug regulations
      • Fluency or working knowledge of French is a plus

    Additional Information

    Salary Range: $89,580 - $133,400

    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.

    While the published salary range is a good faith reflection of the targeted salary level for the position, LVMH Inc. reserves the right to pay outside of the published salary range.

    All of your information will be kept confidential according to EEO guidelines.

    NOTE: This job description is intended to cover the core accountabilities of the position and is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities, and activities may change, or new ones may be assigned at any time with or without notice.