About the job

We are thrilled to announce that we are creating a new strategic position based in our Indian hub. We are looking for both exceptionnal technical and human skills for this position!

About us

Group 10
Responsibilities

  • Contribute to regulatory activities performed on the the Hub
  • Regulatory activities include pre licensing activities, new registration (sites and medicinal products), post licensing regulatory submissions, interaction with health authorities onbehalf of PLG customers
  • Provide regulatory support to clients and associate companies. Assess regulation and inform the clients about the impact on their products or activities
  • Provide on-going regulatory support to the Regulatory Affairs Team Lead and to project teams to ensure regulatory concerns are planned and accounted for and the relevant data are generated to meet project objectives.
  • Lead a global and local team and coordinate the activities
  • Manage budget and center of costs

Group 11
Profile

  • Higher degree in Life Science, PhD in pharma is an asset
  • A solid experience in Regulatory Affairs for the Pharmaceutical industry for a service provider (around 10 years of experience)
  • Experience in Local/Central working envrionement is key
  • Ability to work in a fast paced environment with flexible time zones
  • Change Management experience is a plus (training, managing projects, communication…)
  • Proven team management experience, strong people management skills are essential
  • Project management skills, certification is a plus
  • Familiar with electronic document and information management systems (eg Veeva, eRIMS, eDOC and MyDoc)
    and IT systems (eg MS Word, Excel, Power Point, Lotus Note and Outlook)
  • Excellent communication skills in English language is key for business continuity, any other language is an asset
  • Pro-active attitude and able to work on own initiative as well as part of a team
  • Entrepreneurial mindset
  • Diplomatic attitude
  • Multicultural sensibility
  • Personal responsibility for ensuring a high standard of work

Central Expertise Lead