Job Description

Vice President, Quality Assurance & Regulatory Affairs (Tarrytown, NY)

Prestige Consumer Healthcare is a company that focuses on product innovation and quality in the overthecounter healthcare and womens 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 overthecounter products in North America and are constantly improving and creating products that match the everchanging lifestyles and needs of people and families everywhere.

Job Summary

The Vice President (VP), Quality Assurance and Regulatory Affairs will report to the Chief Executive Officer and will ensure the regulatory and quality compliance of Prestige products throughout their lifecycles and will monitor regulatory and quality developments potentially affecting the business. The VP will also lead Medical Affairs activities including clinical studies, Customer Contact Center, and pharmacovigilance. Product categories include OTC monograph drugs, OTC NDAs, Medical Devices, Cosmetics, Dietary Supplements, and EPAregistered products. The VP will design, implement, and monitor effective compliance strategies that align with the Companys business goals. The VP has a solid overthecounter (OTC) healthcare quality and regulatory affairs background and will assure that all products and contractors meet the applicable quality and regulatory requirements. The VP will develop strategy that supports all brands and new products as well as operational initiatives.

Major Responsibilities/Activities

• The VP serves as a management representative.
• The VP directs and oversees the Companys Quality Assurance, Regulatory Affairs, and Medical Affairs organization to lead the development and implementation of the Companys compliance strategies for its complete portfolio of products.
• The VP serves as the Quality Representative (QR) and Management Representative (MR) and:
• ensures that quality management system requirements are effectively established, documented, implemented, and maintained and meet customer requirements;
• reports to top management on the performance and effectiveness of the quality management system and any need for improvement;
• ensures the promotion of awareness of applicable quality system and regulatory requirements throughout the organization;
• acts as liaison with external parties on matters relating to the Quality Management System.
• The VP fosters close cooperative relationships with all functions in the company relative to compliance, working with Marketing, Product Development, Package Development, Legal, and Operations to execute all product and labeling claims and strategies for the companys brands.
• The VP leads and applies Quality Assurance and cGMP expertise for OTC drug products (monographed and NDA/ANDA), medical devices, dietary supplements, and cosmetics.
• The VP confirms the cGMP compliance of thirdparty contract manufacturers by developing and executing Prestige Consumer Healthcares Quality Assurance programs to ensure the marketing of safe, stable, and legal product.
• The VP maintains New Drug Applications, 510Ks, and other regulatory documentation for all products.
• The VP monitors global Regulatory and Quality developments affecting Prestige products through participation in industry associations, monitoring newsletters and government websites, and communicating significant issues within the organization.
• The VP provides clear direction to Medical Affairs on clinical studies, the Customer Contact Center, and pharmacovigilance.

Qualifications

Education / Certification

• Bachelors Degree in a scientific or healthrelated field; masters degree preferred

Required Knowledge

• Strong knowledge of US OTC NDA, monograph drug, and medical device regulatory requirements and submissions
• Strong knowledge of FDA and FTC claims support requirements
• Strong knowledge of cGMP regulations and requirements in all aspects of manufacturing and distributing OTC drugs and medical devices
• Strong knowledge of ISO 13485:2016
• Working knowledge of Canadian, EU, and Latin American regulations
• Working knowledge of US clinical research methods
• Excellent written and verbal communication skills
• Demonstrated ability to work with people in an effective and positive manner

Experience Required

• 20+ years of experience in US and Canada Quality Assurance and/or Regulatory Affairs in the CPG industry; global experience a plus
• NDA or 510(k) submission and/or maintenance experience
• Demonstrated ability of supervising a team for 10+ years with a successful track record

Travel

20% 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; write reports, business correspondence, and procedure manuals; present information and respond to questions from 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; apply concepts of basic algebra and geometry.

Reasoning Ability

Ability to apply common sense to carry out instructions furnished in written, oral, or diagram form; 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. Employees are regularly required to sit, talk or hear, stand, walk, use hands, reach, stoop, kneel, crouch, or crawl, and occasionally lift up to 10 pounds. Vision requirements 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 accommodate disabilities. The noise level is usually moderate.

Salary Range

$250,000 - $300,000. This range reflects a variety of factors including, but not limited to, candidate experience, qualifications, geographic location, and prevailing market conditions. Compensation also includes a discretionary annual bonus, longterm incentives, and a wellrounded benefits package.

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.

Hybrid Work

We follow a hybrid work schedule. All applicants must be able to work in our Tarrytown office Tuesday/Wednesday/Thursday (remote on Monday/Friday).

Work Hours

40 hours per week.

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