Regulatory Affairs Specialist

vor 3 Wochen

Zug, Zug, Schweiz AbbVie Vollzeit

Job Summary

The Regulatory Affairs Coordinator will be responsible for managing the label lifecycle, regulatory budget, and reporting topics within the Regulatory Affairs department. This role will also provide support in the handling of Medical Devices and ensure compliance with local regulatory requirements.

Key Responsibilities

  • Label Management
    • Prepare, proofread, and approve artwork for products, including drug products and medical devices.
    • Coordinate with labeling centers, manufacturing sites, local QA, and Demand Manager to implement new artwork versions.
    • Publish new and revised product information on the HCI solution platform.
    • Ensure timely label implementation and publication.
  • Administrative Tasks
    • Update tracking lists and online systems within the Regulatory Affairs department.
  • Regulatory Compliance
    • Ensure compliance with local and global regulatory requirements.
    • Collaborate with Global Label Group, Swissmedic, and WE A&AS on label implementation.
  • Regulatory Budget
    • Manage the Regulatory Department Budget excel sheet.
    • Build accruals on a monthly basis.
  • Regulatory Contracts
    • Collaborate with Purchasing to draft contracts.
    • Maintain contracts within the Regulatory Affairs department.

Employee Relations

  • Ensure accurate reporting to the Regulatory Affairs Director and distribution of relevant information within the regulatory team.

Headquarter Relations

  • Ensure accurate, on-time interaction with RA colleagues and WE A&AS.

Qualifications

  • Degree in Pharmacy, Life Sciences, or similar preferred.
  • 5+ years of experience in a similar role within a Regulatory Affairs environment in the pharmaceutical industry.
  • Comply with all relevant Regulatory and Quality policies and procedures.
  • Comply with all relevant company Occupational Health, Safety, and Environmental policies.
  • A desire to contribute to the overall success of the business.
  • A team player with an holistic approach to working in a matrix environment.
  • Well organized and detail-oriented with a proven ability to meet deadlines and achieve goals.
  • Good communication skills.
  • Business fluent in German and English, French is an asset.

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