Senior Manager Regulatory Affairs

BioPhase specializes in recruiting top talented professionals for Scientific communities. We are currently looking for an ONSITE Senior Manager of Regulatory Affairs to work for a leading Los Angeles-based color cosmetics company.

*Applicants must be located and willing to work fully onsite in Los Angeles, CA.

Responsibilities:

• Provide regulatory guidance, advice, risk analysis, and insight for future and existing products to achieve compliance and meet business objectives
• Ensure compliance of all processes and procedures to applicable standards and regulations
• Collaborate closely with the Marketing and Sales teams, as well as other cross-functional leaders, to develop and implement an effective regulatory strategy for both domestic and international markets.
• Ensure regulatory compliance in all aspects of new product development, including chemical formulations, packaging, and adherence to cosmetics and children’s products regulations, while maintaining current knowledge of both domestic and international regulatory requirements.
• Communicate proactively within the company on regulatory strategies, key issues, and any other critical topics throughout the product life-cycle
• Collaborate with the Marketing team to review and approve product labeling/artwork and other marketing materials to ensure compliance with applicable regulations
• Oversee and ensure retailer-driven compliance initiatives are met including WERCS (Worldwide Environmental Regulatory Compliance Solutions)
• Manage existing finished goods and formula compliance and initiate change when demanded by new regulations or business practices
• Manage and direct staff to regularly audit regulatory files and control documents such as SDS, COA, Spec, and Stability to ensure all information is accurate and up to date in preparation for any formal audits
• Assist with product recalls
• Support manufacturing centers and EU for REACH (Registration, Evaluation, Authorization, and Restriction of Chemicals) compliance
• Ensure compliance with MOCRA (Modernization of Cosmetics Regulation Act of 2022)
• Supervise completion of applicable product filings for respective regions including Health Canada CNF, EU CPNP, California Safe Cosmetics Act, etc.
• Work with consultants and internal company personnel to register facilities and OTC products with US-FDA and Health Canada and maintain company compliance as needed
• Work with Marketing and regional distributors to register products in markets outside of US, Canada, and the EU
• Create product testing protocols to meet the requirements of major licensees, and direct and manage staff to carry out those protocols.
• Motivating, developing, and directing people as they work, identifying the best people for the job and assess company and department needs to consider restructuring if needed to optimize efficiency and efficacy
• Travel to the company's international facility as needed; additional international travel may be required.

Requirements:

• Minimum of bachelor’s degree in Chemistry or other science disciplines
• 10-12 years of experience in regulatory affairs preferably in a cosmetic or personal care products company; additional experience in quality control is a plus
• 5-7 years of related supervisory/management experience to include building and developing teams
• Must have 5-7 years’ experience as an active participant with cosmetic-centric FDA audits
• Must be a practitioner of and have a solid understanding of regulations surrounding cosmetics including US-FDA, FPLA (Fair Packaging and Labeling Act), FDC (Food, Drug, & Cosmetic Act), EU Cosmetic Regulation 1223/2009, and Health Canada
• Familiarity with notification streams including US & Canada OTC’s, Health Canada CNF, and EU CPNP is beneficial

What we offer:

As we work to develop innovations that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.

· Full support and career-development resources to help you reach your potential

· A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act

Apply now and let's make work better!

www.biophaseinc.com