Senior Regulatory Affairs Specialist

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 Experience/Training Required:

• 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.