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Manager, Regulatory Affairs Immunology - Stockley Park, UK

Req #: 16001325_1
Location: Hillingdon, England UK
Job Category: Regulatory Affairs
Work Location: Stockley Park, UK
Organization: Celgene R&D Sarl
Schedule: Full-time
Shift: Day Job
Employee Status: Regular
Job Type: Standard
Job Level: Manager
Travel: Yes, 10 % of the Time


Contributes to the initial development, execution & delivery of EU regulatory strategy for projects assigned. Responsible for the building of regulatory dossiers to achieve timely regulatory approvals & maintenance of the existing product portfolio. Liaises with Regulatory Strategy Leader, Regulatory Affairs (RA) Projects Team management & with other internal/external stakeholders. 


Core Responsibilities
  • Contributes to the execution of development & submission strategies in EU for projects assigned.
  • Works with Regulatory Strategy Leader & Regulatory Projects Team leadership to ensure that development programs & product life-cycle plans are aligned with regulatory requirements.
  • Contributes to the assessment of the pros, cons & risks associated with regional strategic options for projects assigned.
  • Contributes ideas to the design of innovative regulatory pathways.
  • Supports Regulatory Projects Team Leadership on development of regulatory tactics to be communicated to internal stakeholders, e.g. Global Project Team as requested
  • May interface between global & regional headquarters to ensure both parties are kept updated on regulatory progress & operational issues & may participate in global regulatory therapeutic area (TA) team.
  • May develop or contribute to the development of high quality regulatory dossiers (e.g., scientific advice requests, orphan medicinal product designation applications, MAAs & variations), ensuring compliance with regulatory requirements.
  • Develops content of regulatory documents working with other functions as necessary & contributes to the review of documents before submission.
  • Reviews draft protocols, acts as Regulatory Project Team representative in clinical study teams & liaises with the Clinical Trials Applications (CTA) group.
  • May act as subject matter expert on designated studies in the event of a Health Authority inspection
  • Responsible for the delivery of Content Plans to allow publishing & timely dossier submission.
  • Responsible for tracking & communicating regulatory activities within RA & responsible for accurate submission plans in eQRMS
  • Identifies & communicates to manager, any emerging issues that may impact Celgene’s business.
  • May participate in interactions with Regulatory Authorities, including agency meetings.
  • Supports the optimisation of product information achieved through negotiation with internal stakeholders & Regulatory Authorities.
  • Supports activities to ensure that Celgene fulfils Health Authority commitments.
  • May participate in regional launch team
  • May be responsible for the regulatory review & approval of commercial advertising & promotional literature
  • Highlights resource constraints through discussion with manager.
  • Identifies any learning or best practice & communicates to manager.
  • Responsible for maintaining knowledge of current EU regulatory guidance & procedures
  • May participate in cross-functional initiatives.
  • International travel may be necessary.




Key Requirements/Knowledge
  • Bachelor’s degree in scientific discipline or equivalent required.
  • Experience in EU Regulatory Affairs & recent experience of EU Centralized Procedure required.
  • Good understanding of current regulatory requirements essential
  • Good understanding of CTD modules; non-clinical, CMC, Clinical
  • Thorough understanding of core processes of drug discovery, development, manufacturing & marketing required.
  • Developing understanding of TA for projects assigned
  • Experience in Inflammation/ Immunology preferred
  • Able to contribute to Ph III protocols & clinical development plans.
  • Takes initiative for professional development
  • Seeks opportunities to learn from others
  • Effective project manager. Prioritises tasks appropriately. Able to & coordinate the delivery of multiple projects
  • Ability to lead routine regulatory submissions. Leads activities for assigned projects
  • Demonstrates appropriate decision making
  • Displays a willingness to challenge the status quo & take risks  & acknowledges others who take the initiative to try new approaches even if the results are not perfect
  • Can identify when to escalate issues to line management & knows when to seek advice.
  • Communicates complex ideas effectively across a culturally diverse environment
  • Communicates effectively  with Regulatory Authorities when tasks have been delegated
  • Obtains alignment through effective communication
  • Ability to influence internal stakeholders
  • Exhibits consistent professional behaviours
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