Regulatory Site Officer

Job description

About the Opportunity

The RSO will be both technical and product expert and will work with the Site Regulatory team in support of product registrations and dossier management while paying a part in supporting Site strategy and GRA initiatives.

About Sanofi Business Unit

The multiple national award-winning Sanofi Waterford biopharmaceutical and medical device campus is located in Waterford on Ireland’s southeast coast. Established in 2001 and now with more than 700 employees, the site has seen more than €600m invested in state-of-the-art infrastructure and technology. Diversification continues to bring new products to Waterford and the expanded site portfolio continues to create new opportunities.

Key responsibilities

·  Is knowledgeable with regard to CMC Regulatory aspects of specific products (commercial and / or clinical)
·  Support product evaluations / changes with regard to regulatory assessment and product transfers
·  Collaborate with local and Global (Development, Technical, Regulatory, Operational and Quality) stakeholders with regard to New Product Introduction – clinical supply, BLA submission, etc.
·  Performs troubleshooting, (cross functional-) investigations, continuous improvements, formal and informal regulatory risk assessments

About You

To excel in this role you will need to have:

Essential requirements:

·  Minimum degree in Science. Ideal – MSc or PhD in a relevant discipline
·  Minimum of 3 years’ experience in Regulatory CMC role in the pharma or biopharma sector

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
·  We have subsidised restaurant with free tea and coffee
·  A newly refurbished gym is available onsite
·  Parking available onsite
·  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.