Global Regulatory Compliance Manager
Our client is a well-known leading SPF brand within the luxury skincare space.
Who you are:
A natural problem solver who is highly organized, detail oriented and resourceful that would like to be a part of a young but fast-growing team. The Regulatory Manager will support the Product Development team in launching products across several global markets and manage all regulatory compliance aspects of the business.
Your Primary Responsibilities Include:
• Ensure all products are compliant with domestic and international regulatory, environmental and shipping regulations.
• Review and approve ingredient lists issued by contract manufacturers ensuring compliance with global regulatory requirements.
• Communicate with raw material suppliers to obtain the necessary documentation to substantiate claims and regulatory requirements.
• Stay up to date on raw material safety and environmental impact research to advise the PD team on ingredient usage while also helping maintain the brand’s ‘no-no- list up to date.
• Prepare and maintain product dossiers that include the ingredient listing, permitted claims, finished goods and bulk specifications, manufacturing procedures, safety data etc.
• Create and maintain libraries for raw materials, product dossiers, packaging artwork, registrations, safety data sheets, etc.
• Work with Retail Marketing to verify compliance with various retail product and brand certifications.
• Develop and maintain testing protocols in compliance with ICH guidelines, domestic and international regulations.
• Manage the preparation and maintenance of files needed for product claims substantiation.
• Support the customer care and field teams in answering customer inquiries.
• Help review and approve packaging labeling and consumer-facing communications (promotional materials, website copy, etc.) for accuracy and regulatory compliance.
• Prepare and submit product registration applications with regulatory authorities worldwide ensuring accuracy and timeliness for new and existing products.
• Independently research, generate and distribute registration documentation; including formulas, specifications, COA’s, Certificates of Free Sale, GMP Certificates, claims substantiation and supporting declarations.
• Partner with service providers to complete legalization for international product registration documents that require notarization and apostille.
• Ongoing maintenance and amendment of registrations worldwide.
• Secure registration and achieve market launch timelines with minimal oversight
• Oversee the production timelines for all international product launches working alongside the PD and Operation teams.
• Prepare product packaging monographs, including the necessary translations, and work with graphic design to create packaging artwork for registration application submissions.
• Oversee all product safety, stability and claims testing.
• Schedule and manage all product annual stability studies.
• Responsible for maintaining and cataloguing an archive of every production lot of every product manufactured.
• Design, implement, maintain and annually review Standard Operating Procedures (SOPs).
• Act as subject matter expert on regulatory affairs
• Keep a close finger on the pulse of the industry regarding evolving trends and the competitive environment with a focus on “Clean” beauty.
• Monitor the evolving interpretation of the new regulation and provide impact reports to senior management, focusing on immediate impact on product registrations, related requirements, and overall long-term business impact.
• Act as primary point of contact and liaison for internal teams, retail partners, distributors and other agencies on all regulatory matters.
• Summarize and communicate regulatory information to multiple regional and international departments and ensure information is correctly interpreted.
• Bachelor’s degree required.
• Minimum of 3-5 years of relevant experience in a similar role.
• Advanced understanding of global OTC and cosmetic regulations and standards including those related to the
FDA, Health Canada, ICH, EU Commission, TGA and other international agencies.
• Product development experience and knowledge of chemistry is a plus.
• Excellent project management and multi-tasking skills.
• Proficiency in MacOs, Microsoft Word, Excel, Powerpoint, and Google Sheets and Docs.
• Working knowledge of Adobe Photoshop and Illustrator a plus.
• Ability to work independently, initiate and lead tasks within defined projects in a fast-paced environment.
• Some travel might be required.