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Senior Regulatory Data and Information Manager (m/f)

Posted 17 Aug 2017

Darmstadt, Hesse - Germany

Req Id 166370

Details

A career is an ongoing journey of discovery: our 52,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others. 


Your role:

 

Based on your expertise with regulatory strategies, product license management and regulatory information management systems (RIMS) you translate regulatory, business and process requirements into technology functionalities. As part of a dynamic data management team within Global Affairs you will help to build a modern technology landscape and manage data into meaningful information.

The future of regulatory operations will be technology driven and you can help to design and build this future by provision of meaningful regulatory data for our worldwide submissions out of the most state-of-the-Art regulatory systems. Your close collaboration with our regulatory experts from headquarters and around the world will bring a global experience to your work. In a future oriented team, you will act as an important counterpart for all regulatory roles and processes towards fit-for-purpose data management and smart system utilization. Your process experience combined with your affinity to technology and data management expertise will help to bridge the current systems and processes with tomorrow’s requirements (e.g. on xEVMPD, IDMP, merged submission processes for dossiers such as eCTD, eAF, CESSP)

 

Who you are:

 

  • At least 5 years of experience working in regulatory product license management and maintenance or  a diploma/master in regulatory affairs
  • Demonstrated experience with Regulatory Information Management Systems and data management
  • Expertise and understanding of underlying regulatory requirements and upcoming trends (e.g. eSubmission such as xEVMPD, IDMP, eAF or CESP)
  • Fluent English, excellent communication skills
  • Collaborative team worker, self-motivated
  • Result-oriented, pragmatic, meticulous working style, high attitude to quality
  • Strong customer orientation

 



What we offer: With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!

Curious? Apply and find more information at

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