Regulatory Affairs Manager
CMC Consultants, Inc.
Our global client has a long and reputable history of producing and marketing high quality brands and delivering customer satisfaction as a leader in the OTC pharmaceutical industry. We are seeking an experienced Regulatory Affairs Manager to lead a diverse portfolio of FDA regulated products including OTC monograph drug products, cosmetics, dietary supplements, and Class 1 medical devices. The ideal candidate will possess strong knowledge of U.S. FDA regulations, leadership skills, and experience bringing regulated consumer health care products to market. Key Responsibilities Regulatory Strategy and Compliance Develop and implement regulatory strategies and ensure compliance with FDA requirements. Product Development Support Partner with R&D, Marketing and Quality teams during product development and commercialization Review product formulations, ingredients, specifications, and labeling for regulatory compliance. Labeling & Claims Review Regulatory Documentation and Submissions Quality & Risk Management Cross Functional Leadership Post-Market Surveillance & Adverse Event Reporting Qualifications Bachelor’s degree in Regulatory Affairs, Life Sciences, Chemistry, Biology, Pharmacy, Engineering, or a related field. Advanced degree in scientific discipline a plus. 5+ years of regulatory affairs experience in FD-regulated consumer healthcare products. Demonstrated experience with OTC monograph drug products, cosmetics, dietary supplements, and/or medical devices. Contact If interested in a career with an outstanding organization, please send your resume with salary history and cover letter to View email address on click.appcast.io #J-18808-Ljbffr CMC Consultants, Inc.
Vacancy posted 3 days ago
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