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www.cvonline.hu

Regulatory Planner


  • Az álláshirdetés 9 napja lett aktiválva
Our partner is one of the world's leading professional business services companies and looking for talented and experienced colleagues for an exciting new pharmaceutical regulatory project.

Responsibilities:
  • Supporting the regulatory submission creation and the registration tracking of the company regulatory submission targets from a regulatory operational perspective for the whole region
  • Working within the Client organization, in the Regulatory Affairs Operations Regional department (Latin America [LA], Asia Pacific [AP], or Europe, Middle East and Africa [EMEA])
  • Taking charge of submission planning
  • Managing Operations aspects of submission planning for assigned products
  • Taking responsibility for document retrieval
  • Dealing with submission creation and delivery to Health Authorities
What you'll need to succeed:
  • Bachelor’s degree in a Life Science related discipline
  • Great knowledge andexpertise of the regulatory landscape, its registration procedures and a thorough understanding of the technical requirements for dossiers (e.g. eCTD and other submission formats)
  • Minimum 2 years’ experience in the regulatory operations area - regulatory affairs will be an asset
  • Able to multitask with project management capabilities including managing dynamic timelines, interacting and negotiating with others, collaboration skill and excellent follow-up ability
  • Excellent communication skills to manage interactions with colleagues within and outside the department to co-ordinate the regulatory submission
  • Capability to keep overview in the complexity of planning, managing, tracking, assembling and delivering of regulatory content, to meet regulatory strategy, regulatory compliance and informational needs for internal and external customers
  • Ability to handle time pressure and the consequence of any delay in timely submissions
  • Affinity to work with complex IT systems
What we offer:
  • Development opportunities, including the shaping of your career path to an advanced direction
  • Different types of bonuses
  • Language courses
  • Stable workplace
  • Opportunity to work from home
Helyek Budapest
Kategória Egészségügy / Szociális ellátás
Aktiválás időpontja 2019.11.27.
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