Offers “Sanofi”

Expires soon Sanofi

Regulatory Affairs Site Officer

  • County Antrim, United Kingdom
  • Personal services

Job description



  Regulatory Affairs Site Officer

About the Opportunity

As the RSO you 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 the Sanofi Business Unit

The 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 multiple national award-winning 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. Sanofi is a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions. With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.

About growing with us

In this role you will….

·  Have in-depth knowledge with regard to CMC Regulatory aspects of specific products (commercial and / or clinical).
·  You will 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.
·  As a member of the team you will performs troubleshooting, (cross functional-) investigations, continuous improvements, formal and informal regulatory risk assessments.

About you

Qualifications/ Education & work experience

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

Inspire your Journey: 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 highly subsidised restaurant with free tea and coffee.
·  A newly refurbished gym is available onsite for a small and highly competitive annual membership fee.
·  Parking available onsite.
·  This is a full-time role and we support flexible working.

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.

Make every future a success.
  • Job directory
  • Business directory