Senior Manager, Regulatory Affairs

Req : 1903723 Location: Hillingdon, United Kingdom Job Category: Regulatory Affairs Work Location: 1 Longwalk Road UB11 1DB Organization: Regulatory Affairs Employee Status: Full-time Job Type: Regular Celgene is a global biopharmaceutical company committed to changing the course of human health through bold pursuits in science, life-enhancing therapies, and a promise to always put patients first. At the core of that mission are the talented individuals who contribute their unique skillsets to help us drive innovation and deliver truly life-changing drugs for our patients. As we continue to pursue that mission, we're looking for talented professionals like you to join our team. What unique gene will you bring to Celgene? You will contribute to the development, execution & delivery of EU regulatory strategy for your assigned projects. You will be responsible for the building of regulatory dossiers to achieve timely regulatory approvals and maintenance of the existing product portfolio by liaising with Regulatory Strategy, Regulatory Affairs Franchise Team management and with other internal/external stakeholders. Daily and Monthly Responsibilities Contributes to the development of EU regulatory product strategy based on Celgene strategic imperatives, product knowledge, global and regional regulatory requirements, including assessment and inclusion of innovative regulatory pathways to achieve regulatory approvals meeting business needs Works with Regulatory Franchise Team Leadership to ensure that EU regulatory product strategy and deliverables are developed in alignment with Global Regulatory Affairs (GRA) and the Global Project Team (GPT) Maintains awareness of emerging issues that may impact regulatory product strategy and Celgene EU regional business. Proposes adjustment of the strategy and implementation plan in response to new information or changes in the competitive landscape and consults with management Maintains knowledge of current EU regulatory guidance and procedures and reviews new guidance for impact on regulatory product strategy and discusses with management Works with Regulatory Franchise Team Leadership to ensure that product development programs and life-cycle plans are aligned with Celgene strategic oversight, business model, Global and EU regulatory requirements May have global responsibility for specific projects which will require; a knowledge of global regulatory requirements, development and ownership of the Regulatory Development Plan (RDP) responsibility for Worldwide submission plans and accountability for global regulatory documents such as clinical trial/marketing applications and for interactions with global Health Authorities Responsible for or contributes to the execution of regulatory product strategy and for achieving timely regulatory approvals with competitive product labels and the maintenance of licences for products assigned Working with other functions as necessary, contributes to the preparation and content of high quality regulatory dossiers (e.g., scientific advice requests, orphan medicinal product designation applications, paediatric waiver requests, MAAs and variations), ensuring compliance with regulatory requirements Contributes to the review of key documents before submission Responsible for or participates in interaction with the with the European Medicinal Agency (EMA), and National Regulatory Health Authorities within the EU for product related discussions Supports or may be responsible for ensuring that Celgene fulfils Health Authority commitments May represent RA at Governance Committees May be responsible for ensuring that GRA, GPT, RA EMA Labelling, Regulatory Operations and Affiliate Regulatory are kept updated in a timely manner, on regulatory product plans progress and operational issues Reviews draft protocols, acts as Regulatory Franchise Team representative in clinical study teams and liaises with the individuals with CTA or CRO oversight responsibility Acts as Subject Matter Expert on designated studies in the event of the Health Authority Inspection Responsible for the delivery of Content Plans to allow publishing and timely dossier submission Responsible for tracking and communicating regulatory activities within RA and for ensuring that submission plans are captured accurately May participate in Global Regulatory and Global/Regional Disease Teams or Launch Team(s) as required May be responsible for the regulatory review and approval of commercial advertising and promotional literature May have responsibility for leading, managing, developing and coaching regulatory staff and may act as a mentor for other RA team members Monitors resource needs through discussion with manager May contribute to planning and monitoring the budget for the assigned projects Identifies any learning or best practice within RA EMEA group and communicates to manager Key Requirements/Knowledge Bachelor's degree in scientific discipline Experience in EU Regulatory Affairs and recent experience of the EU Centralised Procedure Experience of Orphan Drug Designations and registrations in paediatrics In-depth knowledge of current regulatory requirements essential In-depth understanding of CTD modules; non-clinical, CMC, Clinical Thorough understanding of core processes of drug discovery, development, manufacturing & marketing Experience of leading projects through Regulatory Procedures Experience of contributing to Phase III protocols & able to contribute to clinical development plans Preferred knowledge and skills Experience in Haematology / Oncology and / or Inflammation and Immunology Pharmacist or PhD qualification About Us COMMITTED TO IMPROVING THE LIVES OF PATIENTS WORLDWIDE At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients. Our vision as a company is to build a major global biopharmaceutical corporation while focusing on the discovery, the development, and the commercialization of products for the treatment of cancer and other severe, immune, inflammatory conditions. "At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients." There are more than 300 clinical trials at major medical centers using compounds from Celgene. Investigational compounds are being studied for patients with incurable hematological and solid tumor cancers, including multiple myeloma, myelodysplastic syndromes, chronic lymphocytic leukemia (CLL), non-Hodgkin's lymphoma (NHL), triple-negative breast cancer and pancreatic cancer. As committed as we are to clinical accomplishment, we are equally committed to patient support, which is a guiding principle at Celgene. We believe all who can benefit from our discoveries should have the opportunity to do so. Celgene puts patients first with industry-leading programs that provide information, support and access to our innovative therapies.