Senior Regulatory Affairs Specialist at Piscataway

Job Description

Our Clients is a leader in the Consumer Goods Industry and has multiple locations all over New Jersey. Due to a current project they are in need of a Senior Regulatory Affairs Specialist with at least one year of Industry experience.

Responsibilities of the Senior Regulatory Affairs Specialist:

• Performs Drug and Device Registrations for company  manufacture and other sites as required
• Performs Global Registration dossiers (including generating and providing checks for legalizations, etc.) for US exported products, maintains database
• Trains site specific Quality personnel on Drug Listing requirements
• Responsible for the Company Voluntary Cosmetic Reporting program
• Acts as Coordinator for Company  NDC numbers
• Performs database searches for Regulatory Information as needed
• Reviews Regulatory Affairs Departmental Standard Operating Procedures as needed
• Provides regulatory submissions support as follows:
• Cyclic reporting submissions for NDAs/ANDAs
• Supplemental submission formatting, compilation and review
• Other regulatory submission support as needed
• Coordinates Regulatory Alert reporting
• Coordinates and maintains Health Authority Reporting for Company NA site

 

Job Requirements

• The Senior Regulatory Affairs Specialist should have good organization Skills
• Good Net based Database experience  Good computer skills, including excel, word, databases, net systems, and working with IT
• Good communication skills
• Experience working with global community and Regulatory Affairs strongly preferred

 

Education Requirements:

• High School Degree, College Degree preferred

Country: USA, State: New Jersey, City: Piscataway, Company: Atrium Staffing..