Manager, Regulatory Affairs (Tarrytown, NY)
Our Manager, Regulatory Affairs reports to the Director, Regulatory Affairs. The person in this role ensures regulatory compliance of Prestige products throughout the product development life cycle and monitors on an ongoing basis regulatory developments that can potentially affect the business. Product categories include OTC Medical Devices, OTC Drugs, Cosmetics, Dietary Supplements and EPA-regulated pesticides.
- Foster close cooperative relationships with all functions in the company relative to regulatory compliance. Work with Product Development, Package Development, Supply Chain, Legal, Quality Assurance and Marketing to execute all initiatives for specific brands. (40%)
- Provide regulatory guidance to product development teams for assigned brands, including claim substantiation, label reviews and advice on regulatory submissions. (25%)
- Maintain and prepare NDA supplements and/or 510(k) applications as well as other regulatory documentation for assigned brands and products. (15%)
- Assist in the refinement and enforcement of Regulatory policies with particular emphasis on compliance to the company’s Quality System, external regulatory standards (e.g., ISO 13485), and relevant regulations. (10%)
- Monitor global regulatory developments affecting Prestige products through participation in industry associations, monitoring of newsletters and government websites and other methods, and communicate significant issues to management. Ensure that the activities of assigned industry task forces and committees reflect Prestige priorities. (10%)
- Bachelor's Degree in scientific or health-related field and not less than 6 years of experience in U.S. and/or Canadian pharmaceutical or medical device Regulatory Affairs. Master's degree preferred and an equivalent combination of training and experience can be considered.
Required Knowledge, Skills & Abilities
- Significant experience with U.S. drug and/or medical device regulatory submissions and maintenance; OTC preferred
- Strong knowledge of OTC drug and device regulations, including labeling requirements
- Working knowledge of U.S. clinical research and claims support
- Excellent written and verbal communication skills
- Demonstrated ability to work with people in an effective and positive manner
Prestige is an Equal Opportunity Employer
Search Firm Representatives - Please read carefully:
PRESTIGE CONSUMER HEALTHCARE does not accept unsolicited assistance from search firms. Please, no phone calls or emails. All resumes sent by search firms to any employee at Prestige Consumer Healthcare via-email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Prestige Consumer Healthcare. No fee will be paid in the event the candidate is hired by Prestige Consumer Healthcare as a result of the referral or through other means. Thank you for your cooperation.