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Regulatory Submission Planner

Regulatory Submission Planner

HAYS Hungary Kft.
Régió: Budapest
Hozzáadva: 2019.11.09.
Jelentkezési határidő: 2019.11.22.
Regulatory Submission Planner
Did you manage to gain experience in a regulatory or regulatory affairs position?  Here is a great career opportunity which can enable you to broaden your knowledge. Our partner, who is one of the world's leading professional business services companies, is looking for talented and experienced colleagues for an exciting new pharmaceutical regulatory project.

Your new role:

Supports the regulatory submission creation and the registration tracking of the company regulatory submission targets from a regulatory operational perspective for the whole region.Manage Operations aspects of submission planning for assigned products
  • submission planning,
  • document retrieval,
  • submission creation and
  • delivery to Health Authorities

What you'll need to succeed

  • Bachelor’s degree in a Life Science related discipline
  • High level expertise and knowledge of the regulatory landscape, its registration procedures and a thorough understanding of the technical requirements for dossiers (e.g. eCTD and other submission formats)
  • At least 2 years’ experience in the regulatory operations area, regulatory affairs will be an asset
  • Able to multitask with proven 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 for a timely delivery
  • 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 you'll get in return

  • Competitive salary package
  • Colourful, multinational team
  • Opportunity for personal and professional development

What you need to do now
If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.
If this job isn't quite right for you but you are looking for a new position, please contact us for a confidential discussion on your career.

Helyek Budapest
Kategória Gyógyszeripar / Vegyipar
Aktiválás időpontja 2019.11.09.
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