Regulatory Affair Specialist
3 settimane fa
Position: Regulatory Affairs Specialist Location: Hybrid/ Remote Company: Amaris Consulting At Amaris Consulting, we are dedicated to supporting our clients in navigating the complexities of regulatory strategies for the registration and reimbursement of innovative products.
We are seeking a Regulatory Affairs Specialist to ensure alignment with business strategies and regulatory requirements, while maintaining in-line products and monitoring new regulations to foster business growth.
Core Responsibilities Product Registration & Reimbursement: Manage the registration process and inclusion in the National Registry for products, including food for special medical purposes and dietary supplements.
Assess product formulas, advise on appropriate categories, handle submission timelines, verify label claims, and develop mitigation plans.
Negotiate with regulatory authorities to secure product approvals.
Collaborate with New Product Introduction (NPI) project teams to ensure timely completion of tasks and effective communication of regulatory risks and opportunities.
Regulatory Compliance: Implement new regulations and guidance within specified legal deadlines.
Approve labels, datasheets, advertising, and promotional materials, ensuring compliance with local regulations, Codes of Conduct, and Standard Operating Procedures (SOPs).
Technical Support: Provide technical and regulatory support to internal stakeholders, ensuring they are well-informed and compliant.
Independent Work: Demonstrate the ability to work independently while effectively managing tasks and responsibilities.
Minimum Experience / Training Required 2-3 years of experience in a regulated industry (e.g., medical products, nutritional products).
Preferred experience in regulatory affairs; however, backgrounds in quality assurance, research and development, scientific affairs, operations, or related fields will also be considered.
Excellent written communication skills in English and Italian.
Highly developed project management skills.
Strong problem-solving abilities.
A solid understanding of business operations.
What do we offer?
Work towards goals with quarterly monitoring.
Training and technical development path.
Competitive salary.
Inclusive working environment.
Lunch vouchers of 8 € per working day.
Free access to the Mantu Academy platform with more than 500 courses.
Psychological counselling.
Our ideal candidate is recognized in these values: Pioneer Spirit: Desire to explore new technologies, ideas and skills to build a more sustainable world.
Care: Commitment to promoting diversity, meritocracy and safeguarding the environment for a better future.
Performance: The constant ambition to achieve excellence through creativity, innovation and technology.
Trust: Trust is a pillar of progress, driving freedom, creativity and innovation.
Independence: Independence is the basis for a prosperous and agile future.
Join Amaris Consulting and be part of a dynamic team that is committed to excellence and innovation in regulatory affairs.
If you are passionate about making a difference in the industry, we would love to hear from you
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Regulatory Affair Specialist
3 settimane fa
Lazio, Italia Amaris A tempo pienoPosition: Regulatory Affairs SpecialistLocation: Hybrid/ RemoteCompany: Amaris ConsultingAt Amaris Consulting, we are dedicated to supporting our clients in navigating the complexities of regulatory strategies for the registration and reimbursement of innovative products. We are seeking a Regulatory Affairs Specialist to ensure alignment with business...
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Regulatory Affair Specialist
3 settimane fa
Lazio, Italia Amaris A tempo pienoPosition: Regulatory Affairs SpecialistLocation: Hybrid/ RemoteCompany: Amaris ConsultingAt Amaris Consulting, we are dedicated to supporting our clients in navigating the complexities of regulatory strategies for the registration and reimbursement of innovative products. We are seeking a Regulatory Affairs Specialist to ensure alignment with business...
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