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Manager - Regulatory Affairs - Therapeutic Area

4+ years
Not Disclosed
10 July 1, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc/B.Pharm/M.Pharm/Life Science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

 

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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