Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries, and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.
Responsible for development & execution of EU submission strategy for assigned projects and for building regulatory dossiers to achieve timely regulatory approvals & maintenance of the existing product portfolio. Liaises with Regulatory Affairs (RA) Franchise Team management & with other internal/external stakeholders. May be responsible for managing & developing staff.
Responsibilities will include, but are not limited to, the following
scientific advice requests, orphan medicinal product designation applications, paediatric waiver requests, MAAs and variations), ensuring compliance with regulatory requirements. Reviews key documents before submission.
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Celgene is a global biopharmaceutical company committed to improving the lives of patients worldwide. At Celgene, we seek to deliver truly innovative and life-changing treatments for our patients.