Director / Senior Director Regulatory Affairs

Director (or Sr. Director) Regulatory Affairs

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.

The Director (or Sr. Director) Regulatory Affairs will report to the head of Quality & Regulatory Affairs and, under their direction and guidance, will ensure the regulatory compliance of Prestige products throughout the product development cycle and monitor regulatory developments potentially affecting the business. Product categories include OTC Monograph drugs, OTC NDAs, Medical Devices, Cosmetics, Dietary Supplements and EPA-registered products. The Director (or Sr. Director) Regulatory Affairs will also oversee, motivate, and monitor Regulatory staff members, providing direction and reporting as necessary.

Major Responsibilities / Activities :

• Foster close cooperative relationships with all functions in the company relative to regulatory and labeling compliance. Work with Product Development, Packaging Development, Legal, Quality Assurance and Marketing to execute all product application and labeling claims strategies for specific brands and actively lead the risk assessment decision-making process. (40%)
• Provide regulatory guidance to product development teams, including claim substantiation, label reviews and advice on regulatory submissions. (25%)
• Oversee the maintenance of New Drug Applications and other regulatory documentation for Prestige 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, 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%)
• Monitor, provide guidance, and execute performance reviews of staff. Direct the Department to the strategy and goals of the overall organization.
• Actively participate in quality activities such as audits, recalls and CMO meetings

Qualifications :

Bachelor's Degree in Scientific or health related field; Master's degree preferred

Required Knowledge :

Experience Required :

Additional Comments :

Director (or Sr. Director) Regulatory Affairs will collaborate with Operations, Quality, Graphics, Packaging, Product Development, Legal and Marketing :

Travel :

10% 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.