Job Summary:
Novo Nordisk is hiring a skilled Manager – Regulatory Affairs for its Plainsboro, NJ location. This pivotal role involves leading and managing regulatory submissions (INDs, NDAs, BLAs), ensuring compliance with FDA regulations, and collaborating with cross-functional teams to advance pharmaceutical and device projects. If you are experienced in FDA filings and regulatory strategy, this is an excellent opportunity to elevate your career with a global healthcare leader.
Key Responsibilities:
Compile, submit, and maintain INDs, NDAs, BLAs, and device applications to FDA.
Serve as liaison between Novo Nordisk US and affiliates for regulatory documentation.
Maintain comprehensive records of FDA communications and responses.
Stay updated on evolving FDA regulations and guidelines.
Lead regulatory components of simple development projects.
Review and approve product labeling and ensure compliance.
Track application progress through FDA divisions.
Draft and finalize regulatory correspondence and briefing documents.
Participate in regulatory strategy development and project team meetings.
Supervise and guide junior regulatory staff.
Required Skills & Qualifications:
Bachelor’s degree in Life Sciences; advanced degree preferred.
Minimum 4 years of pharmaceutical regulatory affairs experience.
Proven experience in FDA filings such as INDs, NDAs, amendments, supplements.
In-depth knowledge of FDA regulations.
Strong organizational, communication, and leadership skills.
Ability to work independently with minimal supervision.
Previous supervisory/management experience preferred.
Familiarity with diabetes therapies and devices is a plus.
Perks & Benefits:
Competitive base salary: $135,000 – $160,000 per year.
Performance-based bonus eligibility.
Long-term incentive compensation plans.
Comprehensive medical, dental, and vision insurance.
Life and disability insurance coverage.
401(k) plan with company match.
Flexible spending accounts and tuition reimbursement.
Paid parental leave, sick leave, and flexible vacation policy.
Optional benefits: group legal, critical illness, identity theft protection, pet insurance, auto/home insurance.
Company Description:
Novo Nordisk is a global healthcare leader dedicated to improving lives through innovative diabetes care, biopharmaceuticals, and medical devices. With cutting-edge research and patient-focused solutions, Novo Nordisk shapes the future of medicine while fostering an inclusive and diverse work environment.
Work Mode:
On-site – Plainsboro, New Jersey, USA
Call-to-Action:
Ready to lead regulatory excellence in a top pharmaceutical firm? Apply now to join Novo Nordisk and help transform lives globally.
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