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Manager, International Regulatory Affairs United Kingdom,  

Posted on : 26 December 2016

Project Description

Req #: 16001632_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, 15 % of the Time DescriptionSUMMARY Contributes to development of submission strategy for projects assigned Responsible for building  regulatory dossiers to achieve timely regulatory approvals & maintenance of the existing portfolio.   Core Responsibilities " Contributes to development of submission strategy for projects assigned " Provides input  to project teams during the development of regulatory plans & filing strategy to ensure acceptable labelling in markets assigned " Establish within country, cross-product submission plan in association with  Global/Regional Regulatory Lead, Regulatory CMC, commercial, affiliates &/or marketing partners " Creates Content Plans to allow publishing & timely dossier submission. " Responsible for building quality regulatory dossiers.  Works with other functions as necessary " Act as contact person in RA EMEA for local partners & affiliates  as required  " Lead the organisation in the preparation of  answers to questions from regulatory authorities. " Responsible for ensuring that Celgene fulfils Regulatory Authority commitments. " Ability to lead complex regulatory submissions  for assigned projects " Responsible for  tracking all activities & for accurate submission plans in eQRMS and communicating any emerging issues to stake holders in a timely manner. " Ensures that copies of regulatory documents are archived appropriately " Can identify when to escalate issues to line management & knows when to seek advice. " Proposes process improvements to manager. Shares best practice involving International regulatory submissions. " Good understanding of high level strategic issues & implications of Company Core Data Sheet & Regulatory CMC.   *LI-SL1 *MOEU QualificationsKey Requirements/Knowledge " Bachelor s degree in a scientific discipline or equivalent " Experience of leading International Regulatory Affairs (RA) submissions " Strong understanding of International regulatory landscape & required approaches/strategies. " In-depth knowledge of regulatory requirements for countries assigned and good working knowledge of requirements across International region " Thorough understanding of core processes of drug discovery, development, manufacturing & marketing required. " Understands constitution of CTD modules; non-clinical, CMC, Clinical " Understanding of commercial goals and strategy for International region   Competencies/Skills " Takes initiative for professional development & seeks opportunities to learn from others " Communicates complex ideas effectively across a culturally diverse environment  & with Regulatory Authorities when tasks have been delegated " Communicates effectively  with Regulatory Authorities when tasks have been delegated " Ability to influence internal stakeholders " Effective project manager. Delivers quality projects in accordance with timelines. Prioritises tasks appropriately, coordinates the delivery of multiple projects " Must be flexible & adaptable to changing project priorities & work assignments " Displays a willingness to challenge the status quo & take calculated risks " Understands contributions of other departments & external stakeholders " Understands & utilises knowledge of local regulations & business practices when working across cultures " Ability to travel  


Hillingdon England UK

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