Compliance Supervisor leading Quality & Compliance programs at Apotex, overseeing audits and ensuring compliance with regulatory requirements in pharmaceutical manufacturing.
About the role
- Director of Regulatory Affairs managing compliance aspects of beauty product regulations for Luxury Brand Partners. Collaborating with teams to register products and maintain quality assurance.
Responsibilities
- Manage all regulatory compliance aspects of our business
- Ensure formulas and packaging are compliant with regulations in countries in which products are sold
- Registering new products both domestically and internationally
- Oversee product testing and quality assurance
- Collaborate with product development, packaging, operations, and finance/legal, as well as outside advisors
- Stay up to date with regulatory changes impacting ingredients and products
- Ensure all products are in compliance with domestic and international regulatory, environmental and hazmat shipping regulations
- Author & maintain Safety Data Sheets, NAFTA certificates, handle regulatory filings and necessary updates to regulatory filings in each market
- Manage FDA registrations to ensure company compliance with new MOCRA regulations
- Support PD with performing product name trademark searches and compliant product descriptions based on global market requirements
- Work closely with PD to evaluate product and packaging copy and providing feedback and recommended verbiage to ensure claims and verbiage are legal and substantiated
- Risk-assess every product launch (ie formula, product copy, claims, packaging labeling, marketing claims, etc) and call-out any potential concerns
- Generate ingredient lists for labeling of all products
- Perform artwork/label review from both a technical and claims perspective
- Address all product and regulatory questions from the team
- Approval of all product claims and consumer-facing marketing copy
- Perform all OTC evaluations and provide guidance to the team on process and requirements, including development, testing, labeling, copy/claims, FDA registration, launch, complaints, etc
- Compile documentation and maintain European regulatory Product Information Files for each product
- Oversee processes and advise on entering new markets from a regulatory standpoint
- Recommend and oversee quality assurance programs
- Oversee product safety, stability and claims testing (Micro, safety, RIPT)
- Advocate for the company with industry associations and represent Luxury Brand Partners and its brands in industry groups
Requirements
- 10+ years of industry experience in regulatory affairs
- Beauty, Skin Care, Hair Care and/or CPG experience a plus
- Master’s degree in scientific discipline such as chemistry, biology, toxicology or environmental science is a plus
- Expert understanding of global cosmetic and chemical regulations
- Extensive knowledge of safety regulations and industry standards relating to a variety of consumer products in the US, EU and Canada
- Product development experience is a plus
- OTC experience is a plus
- Established industry relationships
- Excellent verbal & written communication and organizational skills
- Extremely detail-oriented
- Strategic thinker who blends strong analytics and creativity and curiosity
- Strong work ethic and can-do attitude
- Problem solving and entrepreneurial in nature
- Ability to manage multiple projects and priorities simultaneously
- Strong team player
- Thrive in a fast-paced entrepreneurial environment
Benefits
- Comprehensive health, dental, and vision insurance along with additional ancillary benefits
- Flexible spending and health savings accounts (FSA/HSA)
- Employer paid life insurance coverage with optional supplemental life insurance available
- Employer paid long-term and short-term disability
- Access to Employee Assistance Program (EAP)
- Starting with 10 vacation days, 4 fixed personal days and 5 sick days (unless state law requires otherwise, in which case we will comply with state law)
- Twelve paid holidays
- Paid parental leave
- Summer Fridays between Memorial Day & Labor Day
- 401(k) with company match
- Monthly technology allowance
- Eligible for annual discretionary bonus
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