The Role

Regulatory Affairs Manager - Biologics

Company: Top 5 Global pharmaceutical company with global headquarters in Paris, In the UK they employ over 1,400 across the Group, including 520 who work out of their UK Head Office in Berkshire providing patients and healthcare professionals with effective treatments for diseases across the following areas: Diabetes, Oncology, Genetic Disorders, Biologics, Cardiovascular - Thrombosis, Vaccines, Generics and Consumer Healthcare.

Role: A new internal opportunity has become available within the RA team for a Senior Manager Global Regulatory Affairs CMC Biologics.In this role you will manage the regulatory activities associated with the Chemistry, Manufacturing and Controls for licensed and clinical biologic products. This position will provide input into the product strategy and to the direction provided to commercial and clinical teams. Primary role location is Waterford, Ireland.

Requirements: Bachelor or ideally Masters scientific, healthcare or life sciences degree, RAC certification is an asset 5+ years of experience in a regulatory function within a matrix environment Knowledge and experience of EU, FDA, and global regulations Experience with biological products Communication, leadership, team spirit, organizational skills IT skills: MS Word, Excel, PowerPoint, MS Project, and Trackwise