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 a diverse and collaborative team involved in various aspects of healthcare, including regulatory strategies, medical education, and product development. The department works closely with the FDA to implement regulatory strategies and ensure patients receive life-changing treatments. Novo Nordisk is committed to improving the quality of life for patients around the world, and the CMR team plays a critical role in this mission.

Position Overview:
Novo Nordisk is seeking a dynamic and experienced Regulatory Affairs Labeling Associate Manager to lead critical tasks related to final printed pharmaceutical labeling. This includes overseeing labeling verification, reviewing physician and patient leaflets, carton and container labels, and device labels, as well as ensuring compliance with FDA regulations and industry standards. The role requires collaboration with cross-functional teams to ensure successful product launch and lifecycle management.

Key Responsibilities:

Labeling Review & Guidance:
- Provide regulatory guidance on commercial labeling materials to ensure compliance with FDA and CFR requirements.
- Identify labeling issues and communicate with stakeholders to resolve them promptly.
- Monitor and recommend improvements to labeling processes, quality, and systems.
Label Development:
- Represent the Regulatory Affairs (RO) Labeling team during Local Labeling Committee (LLC) and Product Labeling Council meetings.
- Drive the final printed labeling review and approval process in collaboration with Therapeutic Area (TA) personnel, LPPC, and Graphic Designers.
- Ensure additional filing requirements (e.g., SPL drug listing, FDA 2253s, Puerto Rico Registrations) are completed.
Labeling Tools & Support:
- Serve as a subject matter expert on labeling tools (SPL, TVT, Veeva Vault, Esko, Acrobat, etc.) and coordinate technical support needs.
- Utilize FDA portals (e.g., WebTrader, CDER NexGen, FURLS, SPL Help Desk, FDALabel) and resolve issues with agencies.
- Provide training, mentorship, and regulatory support for colleagues and contribute to the development of new labeling concepts and techniques.
Regulatory Support:
- Participate in cross-functional teams, offering guidance in troubleshooting and problem-solving.
- Competency in regulatory reports such as Lot Distribution Data, CARES Act Reporting, FDA Establishment Registrations, and more.
- Actively engage in industry meetings and conferences to stay updated on regulatory developments and trends.

Physical Requirements:

0-10% overnight travel required.

Qualifications:

Education:
- Bachelor’s degree required.
Experience:
- Minimum of 6 years of experience in Regulatory Affairs with a focus on labeling development and maintenance.
Technical Knowledge:
- Proficiency in 21 CFR Labeling, Physician Labeling Rule (PLR), FDA Patient Labeling Resources, Medication Guides, and industry-standard labeling trends.
- In-depth understanding of Regulatory Labeling roles, responsibilities, and best practices.
Skills:
- Strong communication, collaboration, and interpersonal skills to work with cross-functional teams.
- Excellent problem-solving abilities with attention to detail and adherence to federal requirements.
- Proven ability to independently manage labeling processes and prioritize tasks to drive successful outcomes.

Equal Opportunity Employer:
Novo Nordisk is an equal opportunity employer. We welcome applicants regardless of race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, veteran status, or any other characteristic protected by law.

Special Assistance:
If you require special assistance or an accommodation to apply, please contact us at 1-855-411-5290. This contact is only for accommodation requests, and cannot be used to inquire about the status of applications.

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Associate Manager - Regulatory Affairs - Labeling

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