BrightOwl Loader Loading

Manager, International Regulatory Affairs Boudry 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   



Find a Job Find Candidates

Similar Jobs

More jobs from Celgene

Other jobs in Switzerland

Other jobs in Boudry

Other jobs from Celgene in Boudry

Other similar job in Boudry

Other Jobs

Most Recent Searches

Most Famous Searches

You might also like