Regulatory Affairs Manager

  • location: Amityville, NY
  • type: Permanent
  • salary: $75,000 - $85,000 per year
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job description

Regulatory Affairs Manager

job summary:
We are looking to add a Regulatory Affairs Manager to one of the top dermatological skin care product manufacturers in the country!

 
location: Amityville, New York
job type: Permanent
salary: $75,000 - 85,000 per year
work hours: 8 to 4
education: Bachelors
 
responsibilities:
  • Oversee FDA filings and have an understanding of OTC dermatology products such as moisturizers, sunscreens, sanitizers,
  • Understand the differences between the products produced are both OTC Consumer Products and Physician delivered topical pharmaceuticals
  • Understand the process of 510K filing with the FDA
  • Understand and able to communicate to leadership what would constitute a " Pre-Market" FDA filing for specific products
 
qualifications:
  • Minimum BS/BA degree, advanced degree preferred
  • Minimum of at least 5 years commercial regulatory experience, reviewing, labeling, and auditing. Preferably in OTC products and dermatology
  • MS Suite experience
 
skills: Regulatory Affairs Operations, Regulatory Affairs Strategy, Regulatory Briefing Documents, Submissions, GMP (Good Manufacturing Practice)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

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