Specialist - Regulatory Affairs - Labeling

Novo Nordisk

4+ years

Not Disclosed

Plainsboro

10 Jan. 3, 2025

Job Description

Job Type: Full Time 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: Labeling Specialist
Location: Plainsboro, United States
Job Category: Regulatory Affairs & Safety Pharmacovigilance

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About the Department:

The Clinical, Medical, and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the organization. From health-care-provider interactions and implementing regulatory strategies with the FDA to providing medical education and supporting new product development, CMR is involved in critical functions at every stage. At Novo Nordisk, we’re focused on improving the quality of life for patients worldwide. As their needs evolve, so does our challenge to innovate and find better ways to address those needs. We’re changing lives for a living. Are you ready to make a difference?

The Position:

The Labeling Specialist will support regulatory labeling activities for all submissions and packaging materials, working closely with cross-functional teams to ensure compliance. This role is responsible for managing the creation, approval, and submission of labeling materials, including maintaining product and establishment registrations in alignment with regulatory requirements. As a subject matter expert (SME) for FDA-compliant reports and electronic submissions (e.g., SPL, LDD), the Labeling Specialist will ensure all labeling items are appropriately tracked and accessible throughout the development and post-launch phases.

Key Responsibilities:

Regulatory Labeling Operations:

Participate in cross-functional teams to plan and execute labeling operations, proactively addressing potential issues and finding solutions.
Work with Regulatory Project Managers to prepare labeling materials in accordance with project plans.
Collaborate in FDA submission planning meetings, ensuring alignment on actions, risks, and decisions related to labeling.
Contribute to the development of SOPs, Work Instructions, and training materials to support labeling activities.

Labeling Systems & Compliance:

Ensure proper tracking, archiving, and accessibility of all regulatory labeling items and information across systems like LIFT, SPL, ALiCE, novoGlow, etc.
Act as a SME for regulatory systems, improving processes and contributing to system enhancements such as Veeva Vault, TVT, and other tools.
Support global and local teams in maintaining compliance with health authority requirements, including FDA and Health Canada submissions.

Collaboration and Process Improvement:

Actively contribute to the improvement of regulatory labeling processes, including managing project risks and facilitating effective communication between cross-functional teams.
Monitor and provide input on product/establishment registrations, including SPL submissions and other FDA-compliant reports.
Ensure alignment with regulatory strategy and compliance across all labeling tasks and project deliverables.

Qualifications:

Education & Experience:

Bachelor’s degree required, with a minimum of 4 years of progressively responsible experience in a pharmaceutical, biotechnology, or related environment.
Experience with labeling development and maintenance is essential, with knowledge of FDA and Health Canada eCTD submission lifecycle and regulations.

Skills & Competencies:

Proficiency with labeling systems (LIFT, Veeva Vault, ALiCE, novoGlow, etc.) and Microsoft Office.
Strong ability to work cross-functionally, managing risks and project plans, and providing clear communication on project status.
Demonstrated ability to improve labeling processes and participate in system improvements.
Excellent verbal and written communication skills.
Ability to collaborate in a fast-paced, global environment and manage multiple priorities effectively.

Why Join Novo Nordisk:

At Novo Nordisk, we believe it’s no longer enough to be the best company in the world; we strive to be the best company for the world. Our diverse workforce and inclusive culture foster innovation and creativity, ensuring we make a life-changing impact on the patients we serve. Join us as we continue to transform healthcare and improve the lives of millions.

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