Senior Regulatory Affairs Specialist Lazio

Senior Regulatory Affairs Specialist
Roma
Lazio, Lazio

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.

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