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Specialist - Regulatory Affairs - Labeling

4+ years
Not Disclosed
10 Nov. 11, 2024
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: Labeling Specialist

Location: [Insert Location]
Department: Regulatory Affairs


About the Department

The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most dynamic and collaborative teams in the company. We are dedicated to improving the lives of patients around the world by supporting the development and delivery of innovative medicines. From regulatory strategy and healthcare provider interactions to data collection and medical education, CMR plays a critical role in ensuring that our products meet the highest standards of safety and efficacy. At Novo Nordisk, we're changing lives for a living—are you ready to make a difference?


The Position

As a Labeling Specialist, you will be responsible for managing regulatory labeling activities for product submissions and ensuring that all labeling materials comply with regulatory requirements. You will work cross-functionally to ensure that the regulatory labeling is completed in a timely and compliant manner for both product launch and ongoing maintenance. This includes supporting systems for labeling creation, approval, submission, and tracking, as well as working closely with various stakeholders across regulatory, clinical, and operational teams.


Key Responsibilities

  • Regulatory Labeling Operations: Collaborate with cross-functional teams to plan and execute regulatory labeling activities, addressing any obstacles and emerging issues proactively.
  • FDA Submissions: Participate in submission planning and ensure clear communication regarding labeling requirements and processes for FDA and other health authority submissions.
  • System and Data Management: Use regulatory management systems (LIFT, SPL, ALiCE, novoGlow) to track, monitor, and archive regulatory labeling information.
  • Cross-functional Collaboration: Work closely with Regulatory Project Managers, Supply Chain, and other departments to prepare and align labeling items with project plans.
  • Process Improvement: Contribute to process improvements and regulatory tools (Veeva Vault, LIFT, TVT) for labeling operations and compliance, while also providing training support for team members.
  • Documentation and SOPs: Develop and maintain Standard Operating Procedures (SOPs), Work Instructions (WIs), and training materials for regulatory labeling-related activities.
  • Compliance: Ensure regulatory labeling complies with Health Authority requirements and company standards for both new and marketed products.

Physical Requirements

  • Travel: 0-10% overnight travel required.

Qualifications

  • Education: A Bachelor's degree in a relevant field (e.g., Pharmacy, Biology, or Life Sciences).
  • Experience: Minimum 4 years of experience in regulatory affairs, specifically related to labeling development, maintenance, or product registrations in the pharmaceutical or biotechnology industry. Alternatively, a combination of relevant education and experience.
  • Skills:
    • Proficiency in regulatory labeling systems (LIFT, Veeva Vault, TVT, ALiCE, novoGlow).
    • Strong knowledge of FDA and Health Canada eCTD submission requirements and regulations.
    • Project management skills and the ability to proactively identify and mitigate risks.
    • Excellent verbal and written communication skills.
    • Ability to work independently and collaboratively in fast-paced environments with both local and global teams.
  • Additional Experience:
    • Experience in managing labeling projects and systems improvements.
    • Knowledge of regulatory processes for SPL and Lot Distribution Data (LDD) submissions.

Why Join Novo Nordisk?

At Novo Nordisk, we are committed to creating an inclusive and diverse workplace where everyone’s contributions are valued. We believe that having a diverse workforce is key to driving innovation and achieving our mission of improving the lives of patients globally. Together, we are life-changing.


Equal Opportunity Employer

Novo Nordisk is an equal opportunity employer. We are committed to providing equal employment opportunities without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status, or any other characteristic protected by applicable laws.


How to Apply

To apply, please submit your CV and cover letter via the online application portal by clicking the Apply button.