Senior Associate Regulatory and Business Continuity

Job overview

The Senior Associate Regulatory and Business Continuity is a hybrid full-time role based in Princeton, NJ. Compensation is 102,500 - 125,000 USD per year, and this position supports the Regulatory Affairs department at Sun Pharmaceuticals, Inc. This role exists to ensure compliance with FDA regulations and support commercial business. The associate will prepare regulatory submissions, coordinate responses to deficiency requests, and manage establishment registrations to ensure product approvability.

What you'll do

• Prepare ANDA submissions, amendments, and supplements.
• Coordinate responses to FDA deficiency requests.
• Review CMC submission documents.
• Prepare and submit eCTD submissions and SPLs.
• Manage establishment registrations and product fees.

What we're looking for

Skills & competencies

full-time

day shift

princeton nj

sun pharma

regulatory

business continuity

fda

compliance

hybrid

senior

Work arrangement

• Weekend coverage required

Benefits & perks

• Medical, dental, vision coverage, life insurance, disability insurance, 401(k) savings plan, paid time off.

Why this role

Hybrid work model, focus on FDA regulatory compliance.

About the employer

Sun Pharmaceuticals, Inc is hiring for this role. Industry: Drugs and Druggists' Sundries Merchant Wholesalers. Sector: 42.