Regulatory Affair Specialist Lazio

Regulatory Affair Specialist
Roma
Lazio, Lazio

Who are we? **:**Amaris Consulting** is an independent technology consulting firm providing guidance and solutions to businesses. With more than 1, 000 clients across the globe, we have been rolling out solutions in major projects for over a decade - this is made possible by an international team of 7, 600 people spread across 5 continents and more than 60 countries. Our solutions focus on four different Business Lines: Information System & Digital, Telecom, Life Sciences and Engineering. We're focused on building and nurturing a top talent community where all our team members can achieve their full potential. Amaris is your steppingstone to cross rivers of change, meet challenges and achieve all your projects with success.

**Brief Call**: Our process typically begins with a brief virtual/phone conversation to get to know you! The objective? Learn about you, understand your motivations, and make sure we have the right job for you!

**Interviews** (the average number of interviews is 3 - the number may vary depending on the level of seniority required for the position). During the interviews, you will meet people from our team: your line manager of course, but also other people related to your future role. We will talk in depth about you, your experience, and skills, but also about the position and what will be expected of you. Of course, you will also get to know Amaris: our culture, our roots, our teams, and your career opportunities!

**Case study**: Depending on the position, we may ask you to take a test. This could be a role play, a technical assessment, a problem-solving scenario, etc.

We look forward to meeting you!

**Job description**:

**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.

- 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.

- Amaris Consulting is a leading company certified by Top Employer 2023 that supports its cross-sector partners at 360 degrees in the sectors of Automotive&Motorsport, Avionic&Aerospace, Defense, Railway, Industrial, Domotica, Robotics and Life science. _

- Join Amaris Consulting and be part of a dynamic team that is committed