Sr. Director, Regulatory Affairs (Tarrytown, NY)

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 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 Responsibilites/Activies

• 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

QUALIFICATIONS:

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

Required Knowledge

• Strong knowledge of US NDA and/or medical device regulatory requirements and submissions
• Strong knowledge of OTC drug and cosmetic regulations
• Working knowledge of US clinical research and claims support
• Working knowledge of dietary supplement regulations
• Excellent written and verbal communication skills
• Demonstrated ability to work with people in an effective and positive manner
  
  

Experience Required

• 15 years of experience in US and/or Canada pharmaceutical or medical device Regulatory Affairs
• NDA or 510(k) submission and/or maintenance experience
• Demonstrated track record of effectively managing teams
  
  

Additional Comments

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

• 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 SOPs and provide training as appropriate
• Propose and meet realistic timelines for regulatory submissions and approvals
• Keep up to date on changes in regulatory requirements related to OTC drug, device, supplement and cosmetic product regulations, including those impacting the Quality function, and communicate these changes within Prestige Consumer Healthcare
• Represent Prestige Consumer Healthcare on assigned industry task forces and ensure that Company needs are addressed
• Responsible for advancing work process for continued regulatory compliance and departmental efficiencies
  
  

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.

Salary Range: $200,000 - $250,000; this range reflects a variety of factors including, but not limited to, candidate experience, qualifications, geographic location, and prevailing market conditions. Compensation will also include a discretionary annual bonus and a comprehensive, robust 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.

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

Work Hours: 40 hours per week.