Regulatory Affairs Manager

Sanofi US; Milano; In loco; EUR 50.000 - 70.000; Tempo pieno

Descrizione del lavoro

A global biopharma company seeks a Regulatory Affairs Manager in Milan, Italy. The role involves providing strategic advice, managing regulatory submissions, and ensuring compliance for existing products. The ideal candidate has proven experience in Regulatory Affairs and is fluent in both Italian and English. Join this dynamic environment making an impact on millions worldwide.

Servizi

Equal opportunity employer

Impact on life-changing treatments

Supportive work environment

Competenze

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

Mansioni

• Provide input for marketed products and prepare regulatory submissions.
• Ensure compliance of regulatory activities for existing products.
• Update Marketing Authorizations and product packaging according to new information.
• Maintain quality and compliance of regulatory activities.
• Highlight compliance issues and propose resolutions.
• Cooperate with other Company functions.
• Follow regulatory changes and assess impact.

Conoscenze

Regulatory knowledge

Analytical skills

Problem solving

Coordination skills

Team working

Time management

Presentation skills

Flexibility

Resilience

Active learning

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 make a significant contribution, both commercially and scientifically, to the success of a development programs.

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 to GRA input for marketed products and contribute on the efficient preparation of the regulatory submission and/or any type of responses document to Health Authority questions in strict 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 the 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 the 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, team working, 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.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.