Senior Regulatory Affairs Specialist

at  Abbott Laboratories

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.

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.

• 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.