Regulatory Affairs Manager (Tarrytown, NY)
Regulatory Affairs and Quality Assurance
The Manager, Regulatory Affairs will report to the Director, Regulatory Affairs and, under the direction and guidance of the Director, ensure regulatory compliance of Prestige products throughout the product development cycle and monitor regulatory developments potentially affecting the business. Product categories include OTC Medical Devices, OTC Drugs, Cosmetics, Dietary Supplements and EPA-registered products.
- Develop the communication strategy and creative calendar for each of his/her assigned brands.
- Foster close cooperative relationships with all functions in the company relative to regulatory compliance. Work with Product Development, Package Development, 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 prepare510(k) applications and 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%)
The Manager, Regulatory Affairs will provide support to Operations, Quality, Graphics, Packaging, Product Development, Legal and Marketing functions:
- Serve as the regulatory representative on identified product development teams
- Create or review US & Canada regulatory submissions that meet company and regulatory agency requirements
- Develop and implement company and departmental SOP’s and provide training/compliance
- Propose and meet realistic timelines for regulatory submissions and approvals
- Keep up to date on changes in regulatory requirements related to OTC drug, device, and dietary supplement regulations and communicate these changes within Prestige Brands
- Represent Prestige Brands on assigned industry task forces and ensure that Company needs are addressed
- Improve work processes for continued regulatory compliance and departmental efficiencies
- Comply with applicable US & Canada regulatory laws/standards
The Manager, Regulatory Affairs will also provide support to Quality Assurance:
- Monitor potential changes in global device, drug, and supplement regulations affecting the Quality function and communicate significant issues to QA staff
- Responsible for any other quality-related duties, as required.
- Provide input where necessary to any SOP revisions related to job functions.
Bachelor's Degree in Scientific or health-related field; Master's degree preferred
- 6+ years of experience in US and/or Canada pharmaceutical or medical device Regulatory Affairs
- 510(k) submission and/or maintenance experience
- Substantial experience with US medical device regulatory requirements and submissions; OTC preferred
- Strong knowledge of OTC drug and device regulations
- Working knowledge of US clinical research and claims support
- Working knowledge of CE Marking and European Technical File format Excellent written and verbal communication skills
- Demonstrated ability to work with people in an effective and positive manner
Prestige is an Equal Opportunity Employer
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