Regulatory Affairs Manager (Tarrytown, NY)

Department: Science Tech                                            

Prestige Consumer Healthcare is a company that focuses on product innovation and quality in the over-the­ counter healthcare and women's health categories to better improve the lives of our customers and their world. For generations, our trusted brands have helped consumers care for themselves and their loved ones. We are the largest independent provider of over-the-counter products in North America, and we are constantly improving and creating products that match the ever-changing lifestyles and needs of people and families everywhere.

JOB SUMMARY:

The Manager, Regulatory Affairs will report to the AVP, Regulatory Affairs and, under the direction and guidance of the AVP, 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.

MAJOR RESPONSIBILITIES/ACTIVITIES:

• 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 prepare NDA supplements and/or 510(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%)

QUALIFICATIONS:

• Bachelor's Degree in scientific or health-related field; master's degree preferred

REQUIRED KNOWLEDGE:

• Substantial experience with US drug and/or medical device regulatory requirements and submissions; OTC preferred
• Strong knowledge of OTC drug and device regulations, including labeling requirements 
• Working knowledge of US clinical research and claims support
• Excellent written and verbal communication skills
• Demonstrated ability to work with people in an effective and positive manner
• 6+ years of experience in US and/or Canada pharmaceutical or medical device Regulatory Affairs

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 U.S. & Canada regulatory submissions that meet company and regulatory agency requirements
• Develop and implement company and departmental SOPs 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 Consumer Healthcare Represent Prestige Consumer Healthcare on assigned industry task forces and ensure that company needs are addressed

• Improve work processes for continued regulatory compliance and departmental efficiencies Ensure compliance with applicable U.S. & Canada regulations, laws, and standards

Travel: 5% ability to travel via car, plane, rail.

LANGUAGE SKILLS:

• Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations.
• Ability to write reports, business correspondence, and procedure manuals.
• Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.

MATHEMATICAL SKILLS:

• Ability to calculate figures and amounts such as discounts, interest, commissions, proportions, percentages, area, circumference, and volume.
• Ability to apply concepts of basic algebra and geometry.

REASONING ABILITY:

• Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form.
• Ability to deal with problems involving several concrete variables in standardized situations.

PHYSICAL DEMANDS:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to sit. The employee frequently is required to talk or hear. The employee is occasionally required to stand; walk; use hands to finger, handle, or feel; reach with hands and arms; and stoop, kneel, crouch, or crawl. The employee must occasionally lift and/or move up to 10 pounds. Specific vision abilities required by this job include close vision, and ability to adjust focus.

WORK ENVIRONMENT:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

The noise level in the work environment is usually moderate.

No Sponsorship: Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time

#HybridWork: We follow a Hybrid work schedule. All applicants must be able to work in our Tarrytown office Tues/Wed/Thurs (remote on Mon/Fri).

Work Hours: 40 hours per week.

Salary Range: $120,000 - $140,000