Associate Manager - Regulatory Affairs - Labeling

6 years

Not Disclosed

Plainsboro United States

10 Feb. 13, 2025

Job Description

Job Type: Full Time Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences 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

Job Title: Regulatory Affairs Labeling Associate Manager

Location: Plainsboro, United States

Department: Clinical, Medical and Regulatory (CMR)

Job Category: Regulatory Affairs & Safety Pharmacovigilance

About the Department:
The Clinical, Medical, and Regulatory (CMR) department at Novo Nordisk is diverse and collaborative, focused on improving patient lives globally. The department interacts with healthcare providers, develops regulatory strategies with the FDA, provides medical education, and supports efficacy and new product development. CMR remains patient-centered, working tirelessly to enhance the quality of life for patients worldwide.

Position Overview:
Novo Nordisk seeks an experienced Regulatory Affairs Labeling Associate Manager to lead key tasks related to the development, approval, and lifecycle management of pharmaceutical labeling. This includes reviewing physician and patient leaflets, carton/container labels, and device labels, ensuring compliance with FDA regulations, industry standards, and company labeling content.

Key Responsibilities:

Label Development:
- Represent Regulatory Affairs Labeling during meetings (e.g., NNI Local Labeling Committee, HQ Product Labeling Council).
- Ensure accurate reconciliation of comments into draft labels with Therapeutic Area (TA) personnel.
- Drive the final printed labeling review process, working with cross-functional teams to meet product launch timelines.
- Ensure all required filings are completed for approved labeling content (e.g., SPL Drug Listing, FDA 2253s, Puerto Rico registrations).
Labeling Tools:
- Serve as a subject matter expert on labeling tools (e.g., SPL, TVT, Veeva Vault, Esko, Acrobat).
- Coordinate technical support with internal IT teams and resolve issues using FDA portals (WebTrader, CDER NexGen, FURLS, etc.).
Regulatory Support:
- Provide guidance and mentorship to colleagues.
- Contribute to new concepts, standards, and techniques in labeling operations.
- Participate in cross-functional teams to troubleshoot and resolve labeling issues.
- Stay current with regulatory developments and industry trends through participation in conferences.
Physical Requirements:
- 0-10% overnight travel required.

Qualifications:

Education: Bachelor's degree required.
Experience: Minimum 6 years of experience in Regulatory Affairs, particularly in labeling development and maintenance.
Skills:
- Proficiency in 21 CFR Labeling, Physician Labeling Rule (PLR), FDA Patient Labeling Resources, Medication Guides, Instructions for Use, National Drug Codes, and industry-standard labeling trends.
- Strong understanding of product listings, establishment registrations, and federal requirements.
- Excellent communication, collaboration, and interpersonal skills.
- Strong problem-solving ability with attention to detail.

Additional Information:

Work Environment: Collaborative and diverse work environment with opportunities for professional growth.
Equal Opportunity: Novo Nordisk is committed to an inclusive recruitment process and equality of opportunity. All qualified applicants will receive consideration for employment without discrimination.

If you require accommodations for the application process, please contact us at 1-855-411-5290.

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Associate Manager - Regulatory Affairs - Labeling

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