Manager – Regulatory Affairs – Therapeutic Area
Location: Plainsboro, New Jersey, United States
Company: Novo Nordisk
Job Summary
Novo Nordisk is hiring a Manager – Regulatory Affairs for its Therapeutic Area team in Plainsboro, NJ. This on-site role focuses on compiling and managing regulatory submissions (INDs, NDAs, BLAs), overseeing FDA correspondence, and supporting compliance across key pharmaceutical development projects. The ideal candidate will have 4+ years of regulatory affairs experience, excellent knowledge of FDA regulations, and strong project leadership skills.
Key Responsibilities
Compile and submit INDs, NDAs, BLAs, and other regulatory applications
Act as liaison with FDA for communications, meetings, and submissions
Review regulatory strategies and support cross-functional project teams
Lead or support preparation of FDA briefing packages
Maintain regulatory databases and documentation templates
Ensure compliance with U.S. federal regulations and internal SOPs
Supervise review and approval of product labeling
Track regulatory applications through FDA review processes
Participate in Global Regulatory Teams and cross-functional meetings
Oversee annual reports and manage timelines for assigned projects
Required Skills & Qualifications
Bachelor’s degree required (Life Sciences preferred); advanced degree a plus
Minimum 4 years of experience in pharmaceutical or device regulatory affairs
Strong understanding of FDA regulatory frameworks for INDs/NDAs
Prior experience compiling and submitting regulatory documentation
Detail-oriented with strong written and verbal communication skills
Ability to manage multiple projects independently
Supervisory or team management experience is advantageous
Knowledge of diabetes therapies is beneficial
Perks & Benefits
Salary Range: $135,000 – $160,000 + annual performance bonus
Long-term incentive compensation and company vehicle options
Medical, dental, and vision insurance (day one coverage)
Life and disability insurance
401(k) plan with company contributions
Tuition reimbursement and employee assistance programs
Paid sick leave, flexible vacation, and parental leave policies
Voluntary benefits including pet, legal, and identity protection
Company Description
Novo Nordisk is a global leader in diabetes care and pharmaceutical innovation. The company’s Clinical, Medical, and Regulatory (CMR) division drives cutting-edge strategies to improve patient outcomes and ensure regulatory compliance. Based in Plainsboro, this hub plays a vital role in shaping the future of patient-centric therapies.
Work Mode: On-site – Plainsboro, New Jersey, USA
Call-to-Action
Join a globally respected regulatory team at Novo Nordisk and contribute to life-saving therapies.
Apply today to elevate your career in regulatory affairs.
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