What are the responsibilities and job description for the Regulatory Affairs Manager (Tarrytown, NY) position at Prestige Consumer Healthcare?
Regulatory Affairs Manager (Tarrytown, NY)
Join to apply for the Regulatory Affairs Manager (Tarrytown, NY) role at Prestige Consumer Healthcare
Department : Science Tech
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
Required Knowledge
Additional Responsibilities
Travel :
5% ability to travel via car, plane, rail.
Language Skills
Mathematical Skills
Reasoning Ability
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
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Legal
Industries
Consumer Goods
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Salary : $120,000 - $140,000
