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Regulatory Affairs Specialist

Company: L'OCCITANE Group
Location: New York
Posted on: September 17, 2020

Job Description:

JOB SUMMARY:The Regulatory Affairs Specialist, as an active member of the Regulatory Affairs team, participates and assists in all regulatory activities for the sale and communication of L'Occitane products in North America (United States and Canada) through sell-in and sell-out channels. This individual helps ensure that L'Occitane products meet and follow all regulatory requirements necessary to conduct business in North America, and serves as a support on internal and external regulatory compliance issues. This role is crucial to keep up-to-date with all latest changes in regulations nationwide as well as state/province specific. JOB RESPONSIBILITIES:Product Communication reviewReview and approve consumer-facing communication (promotional materials, website, digital advertising, press releases---) and local packaging artworks (gift sets) for scientific accuracy and regulatory complianceProvide comments, as necessary, on international product labels to ensure that all product claims meet the North American labeling requirementsShare approved regulatory standard copy with Regional Marketing teamPerform regular audits for product claims complianceConduct regulatory training for individuals having responsibilities with respect to consumer-facing communication to foster regulatory knowledge Product notification, registration and reportingPrepare and submit product notification/registration with relevant authorities in the US and Canada (FDA, Health Canada, California Safe Cosmetics Program---) ensuring accuracy, completeness and timeliness for new and existing productsMonitor adverse events cases and liaise with Product Safety departmentProduct Development regulatory supportAdvise on ingredients and formulation to ensure product compliance with US and Canadian regulations at early stages of development, as well as on scientific data, consumer and clinical testsAssist with validation of local product developments (e.g. accessories) to ensure compliance with North American regulatory standardsRegulatory intelligence and continuous improvementSummarize and communicate regulatory information to multiple regional and international departments and ensure information is correctly interpretedMaintain current knowledge of applicable regulations, participate in regulatory monitoring, identify risks and opportunities associated with changesDevelop competitive intelligence reporting from a regulatory perspective Partner with external counsel when necessaryDesign, implement, maintain and annually review Standard Operating Procedures (SOPs) All other duties or projects as assignedKEY PERFORMANCE INDICATORS:Project deadlines, Accuracy, Time to review and complete REQUIREMENTS: EDUCATION Bachelor's Degree or foreign equivalent in a scientific field (biochemistry, biology, chemistry or related scientific field)EXPERIENCE1-3 years of experience in a Regulatory Affairs position in cosmetic-drugs/personal care industriesExperience with product claims development and review requiredExperience in preparing and submitting product notification or registration for cosmetics and OTC drug products--SKILLSWorking knowledge of U.S. and Canadian cosmetic and OTC drug regulationsDelivery and results focus, with high level of attention to detail and strong work ethicMust be able to function in fast-paced environment and juggle multiple responsibilitiesStrong organizational skills with the ability to meet project deadlinesDemonstrates an immediate sense of urgency as well as flexibilityProficiency with Microsoft Word, Excel, Outlook, and PowerPointFrench speaking is a plus--L'Occitane North America offers a competitive compensation package and a comprehensive benefit offering that includes: Medical, Dental & Vision Plans, Healthcare, Dependent Care, Transit and Parking Flexible Spending Accounts, Life Insurance, 401(k) Plan, Generous L'Occitane discount, Paid Vacation, Personal Days, Summer Fridays and Holidays.L'Occitane North America is an equal opportunity employer. We value a culture of inclusion and diversity within our workforce. We are committed to maintaining a workplace free from prohibited employment conduct, including discrimination based on age, color, disability, marital or parental status, national origin, race, religion, sex, sexual orientation, gender identity, veteran status or any other legally protected status in accordance with applicable federal, state and local laws.Employment is subject to verification of references and background check investigation.

Keywords: L'OCCITANE Group, New York , Regulatory Affairs Specialist, Other , New York, New York

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