Manager – Regulatory Affairs (Therapeutic Area) – Plainsboro, USA
Job Summary:
Novo Nordisk is seeking an experienced Regulatory Affairs Manager to oversee key regulatory submissions and projects in therapeutic areas. Based in Plainsboro, New Jersey, this role involves managing FDA communications, supervising staff, and coordinating IND/NDA/BLA filings. Ideal for professionals with a background in life sciences and 4+ years of hands-on regulatory experience, this role offers an opportunity to impact patient care globally while collaborating with cross-functional teams.
Key Responsibilities:
Manage IND/NDA/BLA submissions to FDA and maintain accurate documentation.
Serve as a regulatory liaison with FDA and internal project teams.
Supervise and support regulatory associates; review and approve product labeling.
Lead annual report preparation and ensure compliance with federal regulations.
Draft briefing packages and regulatory strategy documents for FDA interactions.
Maintain regulatory knowledge and ensure SOP and template alignment with guidance.
Monitor regulatory timelines and maintain databases for submission histories.
Required Skills & Qualifications:
Bachelor’s degree in Life Sciences required; advanced degree preferred.
Minimum 4 years of regulatory experience in the pharmaceutical or medical device industry.
Strong working knowledge of FDA regulations, IND/NDA processes.
Excellent communication, project management, and leadership skills.
Previous experience managing FDA meetings and regulatory documentation.
Experience with diabetes-related products is a plus.
Ability to work independently with minimal supervision.
Perks & Benefits:
Base salary: $135,000 to $160,000 based on experience.
Eligible for company performance bonus and long-term incentive plans.
Comprehensive health insurance: medical, dental, vision, life, and disability.
401(k) savings plan, flexible spending accounts, and tuition reimbursement.
Paid parental leave, vacation, and sick leave.
Access to wellness programs and optional voluntary benefits (e.g., pet insurance).
Company Description:
Novo Nordisk is a global leader in the pharmaceutical industry, advancing care in diabetes, chronic diseases, and drug innovation. With over 72,000 employees worldwide, we are driven by science and purpose—to change lives.
Work Mode: On-site – Plainsboro, New Jersey
Experience Required: Minimum 4 years in regulatory affairs
Salary Range: $135,000 – $160,000 + bonus & benefits
Application Deadline: Open until filled
Call to Action:
Ready to lead critical FDA submissions and regulatory projects for a global pharma innovator? Apply now to join Novo Nordisk and make a meaningful impact in patients’ lives.
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