Senior Associate, Regulatory Affairs

Job Title:

Senior Associate - Regulatory & Business Continuity

Job Grade:

G10

Department:

Regulatory & Business Continuity

FLSA Classification:

Exempt

Manager’s Job Title:

Sr. Manager, Regulatory & Business Continuity

Department Head

Title:

Global Head of Regulatory & Business Continuity

Does This Position Have Any Direct

Reports?

No

Job Description Approval Date:

September 2025

Job Summary

You will work closely with the Regulatory Affairs Sr. Manager to ensure the compliance and completion of assigned activities and provide regulatory assessment in compliance with US FDA regulations, guidance, and applicable industry guidelines to internal and external stakeholders, and ensure the implementation. This position will be located at Princeton, NJ.

Area Of Responsibility

• Prepares the submissions (ANDAs, amendments, supplements, annual reports) to support commercial business and to be in compliance to FDA regulations.
• Coordinate with all stake holders in preparing for deficiency responses for the submissions (ANDAs / supplements)
• Review CMC submission documents from regulatory perspective to meet scientific and technical requirements for acceptability and approvability by FDA
• Prepare, review, compile and submit eCTD submissions through Electronic Submission Gateway (ESG)
• Maintain regulatory databases by regularly updating information for completeness and ensuring correctness.
• Create, review, and approve labeling materials/artwork for prescription and over-the-counter (OTC) products for ANDAs/ 505b2 product ensuring legal and regulatory requirements for original, under review & post-approval levels
• Developing labeling considering carve outs due to protected language associated with patent/exclusivities; and preparation of side-by-side annotation of labeling
• Review and implement of Safety Labeling Changes and Reference Listed Drug (RLD) labeling updates
• Handling of OTC Product Labeling as per Private Label Distributors (PLDs) requirements
• Drug Listing (SPLs)/ Blanket No Change Notifications submissions
• Timely preparation and review of REMS correspondence/ changes for FDA submission
• Review and prepare RA assessments of change control for completeness and accuracy under RA Manager’s supervision
• Perform other duties as assigned

Work Conditions:

• Hybrid: 3 days in office; 2 days remote

Physical Requirements:

• Able to operate computer/office machines
• Lift and/or move up to 20 pounds

Travel Estimate

Up to 20%

Education and Job Qualification

Bachelor’s degree in Pharmacy, Chemistry or life science is required. Advanced degree in Regulatory Affairs or pharmaceutical science preferred.

Experience

• 3-5 years of related Pharmaceutical Industry experience preferably in Regulatory Affairs
• Must be highly organized and have the ability to meet critical timelines
• Very strong organizational skills that is necessary to manage and multi-task various activities.
• Experience and knowledge in the preparation of major regulatory submissions and supportive documents.
• Familiarity with TVT/ AMS or other artwork management software & use of structured product labeling tools preferred
• Having knowledge of FDA eCTD submission standards for US Applications
• Experience using change control systems, ideally Track-Wise, required
• Proficiency in Microsoft Office/ Adobe Acrobat Professional
• Ability to work cross-functionally to attain goals

Print Name

Sign Name

Date

Employee

Manager

Human Resources