Regulatory Affairs

Job description

Regulatory Affairs

About the Opportunity

Directly reporting to Regulatory Affairs Lead Portugal. You will be responsible for management of new Marketing Authorization Applications (MAA), variations, notifications and renewals submissions in the site of Health Authorities and translation of regulatory documents; you will ensure the ethical level of the company; you will manage artworks, promotional materials and Regulatory Affairs procedures; you will give regulatory support to internal and external stakeholders.

About Sanofi Business Unit

In the area of diabetes and cardiovascular you will find an international work environment in which you can display your talents and make ideas and innovations in teams.

You can design your personal career at Sanofi and we support and accompany your professional and personal development with determination.

As a company dedicated to health care, Sanofi offers diverse and global professional careers.

Key responsibilities

·  Submission of variations and renewals within the deadlines defined either the Corporate or by Health Authorities;
·  Translations of regulatory documents;
·  Update of databases within the deadlines defined in the Quality Documents or requested by Corporate;
·  Launch, validation and approval of packaging materials in VISTA according to the defined deadlines given by Corporate;
·  Act as Regulatory representative in Ad hoc projects;
·  Validation /approval of promotional materials as per local and global procedures.

About You

·  Degree in Pharmacy or similar;
·  English fluency, spoken and written;
·  Good command with Microsoft-Windows tools;
·  Previous Regulatory Affairs experience;
·  Good knowledge of National/ European legislation;
·  Good communication and interpersonal skills;
·  Good organizational and planning skills.

What Sanofi can offer you

·  A role where you are instrumental to creating best practice and as the organisation grows, you can too;
·  We offer a generous package including flexible benefits, and are committed to helping you have a healthy work-life balance throughout your career with us;
·  This is a full time role and we support flexible working.

About Sanofi

Empower Life Everyday

At Sanofi we work across human health from vaccines to rare diseases, and consumer healthcare. This creates opportunities to work across different areas to build a diverse and exciting career. Sanofi has the capabilities and resources to support your aspirations to fulfill your ambitions and be the best you can be.

Our purpose at Sanofi is to work passionately every day to understand and solve healthcare needs of people across the world. Our ambition is by 2025, to be a top 3 innovative, global and diversified human healthcare company. One that embraces transformative technologies and is focused on its area of excellence, which means we're not there to try to solve everybody's problems. We want to focus on those areas where we know we are making a difference.

The values we are live by are teamwork, courage, respect and integrity.

At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.