Director, Regulatory Affairs

Role Overview

• Act as subject matter expert on regulatory affairs, safety and quality assurance.
• Manage the regulatory department and oversee the day-to-day work of all regulatory associates.
• Understand and manage formula and packaging compliance with US (e.g. California labeling guidelines) and international regulations for new and existing products.
• Stay up to date with regulatory changes impacting ingredients and products and communicate developments to management and suppliers.
• 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 (e.g., US, Canada, Europe).
• Manage FDA registrations to ensure company compliance with new MOCRA regulations.
• Ensure compliance with California Air Resource Board.
• Support PD with performing product name trademark searches and compliant product descriptions based on global market requirements.
• Support PD and marketing in clinical and consumer product claims testing.
• 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. Final approval of primary and secondary copy.
• 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 (e.g., ICMAD, PCPC).
• Act as primary point of contact and liaison for internal teams, vendors and regulatory representatives, MOH, etc.
• Advise on ingredient usage, from a regulatory and marketing perspective for new formulation.
• Create new operating procedures and protocols and create standardized written policies.
• Proactively educate the team on ongoing or potential new regulations that may be passed into law; most importantly for the PD team to initiate reformulations and/or revisions with packaging and labeling.

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
• Compensation commensurate with industry standards and your qualifications
• 401(k) with company match
• Monthly technology allowance
• Eligible for annual discretionary bonus