Job Description

Title Lead Associate- OTC
Department Regulatory Affairs
Reports To Team Lead -Regulatory Affairs
Location Hybrid – Princeton, NJ ( On-Site 4 Days/Week)
Assignment Length 6 months (possibility to extend)

Requirement
Provide support to the North America Regulatory Affairs team, for commercial activities associated with Over- The- Counter (OTC) products including but not limited to Labeling/ BOM management, Life cycle management, FDA compliance activities, etc.

• Provide regulatory support for OTC commercial operations
• Job responsibilities include artwork management (creation of artwork, manuscripts, review and approval of submission artworks and private label), Bill of Materials review and approval, NDC assignment and drug listing and represent team in OTC meetings with CFT
• Provide Support for compilation of Annual Reports for NDA/ANDAs in consultation with Team Lead, RA
• Support Daily Regulatory submissions to the FDA
• Coordinate with global RA team to facilitate post approval submissions
• Provide timely support to Internal cross functional teams (including customer inquiries)
• Providing launch support w.r.t Commercial artwork creation and NDC listings in consultation with Lead, RA
• Ensure regulatory compliance for marketed products.

Qualifications

• 2-5 years’ experience in Regulatory Affairs; BS/MS degree in a scientific discipline preferred
• Prior experience (min 1-2 years) in creation / review and approval of OTC labeling
• Proficiency in 21 CFR 201 labeling requirements
• Familiarity with Regulations and Guidances published by USFDA pertaining to OTC labeling, structured product labeling and NDA/ANDA post approval Lifecycle Management
• Familiarity with FDA cGMP requirements
• Ensure appropriate maintenance and archival of regulatory document files

Excellent organizational and time management skills, Strong oral and written communication skills required