Regulatory Affairs Associate

4 weeks ago

Tarrytown, United States Emerge Talent Cloud Full time
Job DescriptionJob DescriptionPosition
Regulatory Affairs Associate (Tarrytown, NY)Department:
Science & Technology
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 Regulatory Associate will report to the Senior Manager, Regulatory Affairs and, under the direction and guidance of the Associate Vice President, will help to ensure regulatory compliance of Prestige marketed products. Product categories include OTC Monograph drugs, OTC NDAs, Medical Devices, Cosmetics, Dietary Supplements and EPA-registered products. The individual must be data driven/analytical and able to develop and maintain effective working relationships with external suppliers and internal team members.

MAJOR RESPONSIBILITIES/ACTIVITIES:​​​​​​​ 
Seeking a skilled Associate to perform these responsibilities including, but not limited to:
  • Prepare reports by collecting, analyzing, and summarizing regulatory and compliance data and trends such as intelligence, compliance, local, state and federal regulations (FDA, HC and EPA)
  • Product and Facility listing registration (e.g., drug, medical device, cosmetic, packaging (GUDID)) 
  • SDS (Safety Data Sheet) compilation and maintenance
  • State license maintenance (e.g., pharmacy, wholesale, manufacturing licenses)
  • Regulatory documentation and record-keeping
  • Maintenance of regulatory databases and systems
Additional Responsibilities:
  • Stay up to date with changing regulations and guidance documents
  • Prepare and review regulatory documents (e.g., labels, packaging, advertising)
  • Review product labeling for regulatory accuracy
  • Assist with regulatory affairs projects and initiatives as needed, including support for regulatory submissions (e.g., 510(k), APRs, PSURs)
  • Provide regulatory guidance and training to internal teams 
  • Provide cross-functional support to groups including Operations, Quality, Graphics, Packaging, Product Development, Legal and Marketing as directed by the Sr. Manager, Regulatory Affairs.
 
REQUIREMENTS:
  • Bachelor's degree in a scientific field (e.g., biology, chemistry, pharmacy)
  • Knowledge of FDA regulations and guidance (e.g., CFR, ISO, CPSC, DHEA regulations)
  • Strong organization, written and oral communication skills, and perform tasks with accuracy and a high attention to detail.
  • Ability to work in a fast-paced environment and prioritize tasks
  • Demonstrated experience with Microsoft Office Suite
  • Must be able to work in Tarrytown, NY in a hybrid schedule (3 days in office – Tuesday, Wednesday, Thursday, and 2 days remote – Monday, Friday)
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. 
 

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