Regulatory Affairs Specialist

13 ore fa

Roma, Lazio, Italia Abbott Laboratories A tempo pieno

Job Summary:Support the development and implementation of regulatory strategies for the registration and reimbursement of new products at Abbott Laboratories, ensuring alignment with business objectives and regulatory requirements. Monitor new regulations and maintain in-line products to support business growth. Assess the impact of upcoming regulations on products for external engagement through Abbott and trade associations.

Key Responsibilities:

  • Product Registration & Reimbursement:Manage product registration, inclusion in the National Registry, and reimbursement processes for products such as food for special medical purposes and supplements. This includes assessing formulas, advising on product categories, handling submission timing, verifying label claims, and setting mitigation plans. Negotiate with regulatory authorities to ensure approval and participate in NPI project teams to ensure timely task completion and clear communication of regulatory risks and opportunities.
  • Regulatory Compliance:Implement new regulations and guidance within legal deadlines. Approve labels, datasheets, advertising, and promotional materials, ensuring compliance with local regulations, Codes of Conduct, and SOPs.
  • Technical Support:Provide technical and regulatory support to internal stakeholders.
  • Independent Work:Capable of working independently from the manager.

Requirements:

  • 2-3 years of experience in a regulated industry (e.g., medical products, nutritionals).
  • Preferred experience in regulatory affairs, but may consider backgrounds in quality assurance, research and development/support, scientific affairs, operations, or related areas.
  • Excellent written English and Italian communication skills.
  • Highly developed project management skills.
  • Excellent problem-solving abilities.
  • Strong understanding of business operations.

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