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
- 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
- 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.