Regulatory Affairs Specialist

6 days ago


Edison, United States Mario Badescu Skin Care, Inc. Full time

Regulatory Affairs Specialist will play a critical role in protecting Mario Badescu Skin Care through balanced compliance and will manage all aspects of regulatory activities necessary to maintain and grow our business. This position is based in our Edison NJ location.


Responsibilities:

-Work with The Good Face Project screening software and our international team to ensure compliance with worldwide regulatory requirements.

-Provide regulatory support for new product registrations, Certificates of Free Sale, labeling compliance, SDS authoring, PIF preparation per various international specific country registration requirements.

-Develop and maintain procedures and systems to perform regulatory operational activities.

-Implement regulatory strategies for launching new products and maintaining existing products.

-Keep abreast of new regulatory changes in all target markets globally and new cosmetic regulations and guidelines and ensure adherence throughout the product life cycle.

-Work closely with distributors/retailers and registration agencies to register products for domestic and global sales.

-Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions.

-Maintain Regulatory filings and Health Authority communications through electronic and paper records in a timely, accurate and efficient manner.

-Provide input on worldwide regulatory requirements and standards to development teams and ensure that requirements are incorporated in product development.

-Review and approve product labeling and promotional materials to ensure regulatory compliance.

-Work with our creative team to review and approve product labels, kit packaging and collateral for U.S and international compliance.

-Work with Marketing to provide review, comments and approval of all product claims

-Work with our laboratory and product development teams to ensure compliance for new products.

-Manage and review third party testing reports.

-Provide review, comments and approval of all product claims for technical accuracy and regulatory compliance. Offer alternative solutions and risk levels with business consequences as needed.

-Create regulatory data for all ingredients and raw materials.

-Attend all applicable meetings as regulatory representative


Requirements:

-5+ years of Cosmetic or related industry experience, including 5+ years of Regulatory experience.

-Bachelor's degree in Chemistry, Biology or related science, required. Master's degree, preferred.

-Must have a strong understanding and knowledge of U.S. cosmetic regulations and international cosmetic regulations/ U.S. Food & Drug Administration (FDA) / U.S. Federal Food Drug and Cosmetic Act / U.S. Federal Fair Packaging and Labeling Act / U.S. State Regulations, pertaining to the compliance and safety of practices of cosmetic and OTC products to Consumer Product Safety Commission.


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