BrightOwl Loader Loading

Manager, International Regulatory Affairs - Switzerland  

Celgene (company)


Posted on : 26 December 2016

Project Description

Job Category: Regulatory Affairs
Travel: Yes, 15 % of the Time

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 our company 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.  

Key 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