Regulatory Affairs Manager

Sanofi; Milano; In loco; EUR 70.000 - 90.000; Tempo pieno

Descrizione del lavoro

A leading biopharma company is seeking a Regulatory Affairs Manager in Milan, Italy. In this role, you will provide strategic and technical guidance, collaborate with various functions, and ensure compliance in regulatory activities. The ideal candidate has significant experience in Regulatory Affairs, a scientific degree, and fluency in Italian and English. This opportunity offers the chance to make a meaningful impact on global health initiatives.

Servizi

Health insurance

Career growth opportunities

Work-life balance initiatives

Competenze

• Significant and proven experience in Regulatory Affairs.
• Fluent in Italian and English – written and speaking.

Mansioni

• Provide input for regulatory submissions and responses to Health Authority questions.
• Ensure maintenance and compliance of regulatory activities for existing products.
• Update Marketing Authorizations and product packaging in accordance with current licenses.
• Highlight compliance issues within the portfolio.

Conoscenze

Flexibility

Resilience

Active learning

Coordination skills

Teamwork

Problem solving

Regulatory knowledge

Analytical skills

Time management

Presentation skills

Formazione

Scientific Degree

Descrizione del lavoro

Regulatory Affairs Manager

• Location: Milan - Italy

About the job

As Regulatory Affairs Manager within our Italian Regulatory Affairs, you’ll provide strategic and technical advice at the highest level in the company. In this way, the team makes a significant contribution, both commercially and scientifically, to the success of development programs. Ready to get started?

Ready to push the limits of what’s possible? Join Sanofi in one of our corporate functions and you can play a vital part in the performance of our entire business while helping to make an impact on millions around the world.

About Sanofi:

We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives.

Main responsibilities:

• Provide input to GRA for marketed products and contribute to the efficient preparation of regulatory submissions and/or any type of response documents to Health Authority questions in cooperation with GRA and other functions (Medical, Pharmacovigilance, etc.);

• Ensure maintenance and compliance of regulatory activities for existing products;

• Ensure that Marketing Authorizations, product packaging and associated information are updated in accordance with current product licenses and in line with new safety information in a timely manner and inspection readiness;

• Ensure quality and compliance of local regulatory activities in line with corporate regulatory affairs, national and European regulations;

• Highlight compliance issues with all products within the portfolio and make proposals for their resolution;

• Maintain a good relationship cooperating with all other Company functions;

• Follow regulatory changes and assess potential impact on daily activities.

About you

• Experience: significant and proven experience in Regulatory Affairs;

• Soft and technical skills: Flexibility, resilience, active learning, coordination skills, reading comprehension, teamwork, problem solving; Regulatory knowledge, analytical skills, time management, presentation skills, write-right;

• Education: Scientific Degree;

• Languages: Fluent Italian and English – written and speaking.

Why choose us?

• Make your work count by supporting a company that brings life-changing treatments to millions — and is committed to doing right by patients, communities, and the planet;

• Drive progress from within by helping simplify, scale, and modernize how a global biopharma business delivers smarter, faster, and more sustainably;

• Support teams across science, medicine, and operations by building better systems, shaping bold strategies, and enabling innovation at speed;

• Make an impact across borders and functions, collaborating with leaders to turn complex challenges into real-world solutions.

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