Senior Regulatory Affairs Specialist

4 giorni fa

Lazio, Italia Buscojobs A tempo pieno

Job Summary: Support regulatory strategy for the registration and reimbursement of new products, ensuring alignment with business strategy and regulatory requirements. Maintain in-line products and monitor new regulations to support business growth. Assess the impact of upcoming regulations on products for external engagement through Abbott and Trade Associations.

Core 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.
    • Assess formulas, advise on product categories, handle submission timing, verify label claims, and set mitigation plans.
    • Negotiate with regulatory authorities to ensure approval.
    • Participate in NPI project teams, ensuring 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.

Minimum 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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