Regulatory Affairs Assistant Manager
Scope of Position The Regulatory Affairs Assistant Manager ensures global compliance for cosmetic and OTC drug products by leading and supporting regulatory activities. Reporting to the Regulatory Affairs manager, this role implements regulatory strategies, supports product registrations, and drives process improvements to maintain current and future compliance. The position also develops and enforces processes and protocols to uphold robust regulatory practices across the organization.
Responsibilities
- Support FDA and international regulatory compliance for OTC drugs and cosmetics, including facility registrations, product listings, and dossier preparation.
- Assist in maintaining quality system initiatives such as QMS, audits, SOP development, and continuous improvement efforts.
- Act as a liaison with global in-market representatives and cross-functional teams, clearly communicating regulatory requirements.
- Research and interpret chemical, packaging, and sustainability regulations, including EU REACH law, Canadian regulations (CNFs), and state-level requirements (e.g., Prop 65, EPR).
- Support marketing materials, labeling, and product claims to ensure regulatory compliance.
- Maintain compliance with the Cosmetic Fragrance and Flavor Ingredient Right to Know Act (CFFIRKA) and retailer-specific regulations, using tools such as WERCSmart and Smarter Sorting.
- Manage the internal regulatory database to ensure accurate, up-to-date information.
- Prepare and maintain product dossiers, ensuring all relevant testing and documentation meet cGMP standards.
- Contribute to global regulatory strategies for short- and long-term business planning.
- Support global consumer complaint monitoring and regulatory response processes.
Qualifications
- Minimum 7 years in regulatory roles within the CPG and/or OTC drug industries.
- Expertise in FDA OTC drug regulations, Health Canada regulations, and EU regulations.
- Experience with global product registrations and dossier preparation.
- Knowledge of cGMP requirements, label and claims review processes, and SOP development.
- International regulatory experience preferred.
- Strong collaboration skills and ability to work cross-functionally in project teams.
- Experience in manufacturing environments.
- Proficient in Microsoft Office and Smartsheet; statistical evaluation and data analysis skills are a plus.
- Excellent verbal and written communication skills, with an open and transparent communication style.
Education
- BS or MS in Chemistry, Biology, or a related discipline
Reasoning & Problem-Solving
- Ability to define problems, collect data, establish facts, and draw valid conclusions.
- Able to solve complex problems and make decisions with limited information.
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