Senior Regulatory Data Manager (all genders)

Posted 24 Jul 2019

Darmstadt, Hesse - Germany

Req Id 194567

Details

A career at our company is an ongoing journey of discovery: our around 52,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For more than 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:

Self-driven, detail-oriented and enthusiastic about an exciting challenge in the regulatory affairs, you will find here the perfect role for yourself! As a Senior Regulatory Data Management, you will ensure efficient processes, manage and guide personnel and oversee data management operations to ensure quality and timely delivery of high-quality regulatory data. You will drive the regulatory transformation  to the next level considering advanced technologies like process mining, automation and artificial intelligence. The role contributes as Subject Matter Expert with dedicated business process know how for Regulatory Information Management and Standards to our cross-functional projects and strategic initiatives like IDMP as well as the implementation of Veeva Vault. As Senior Regulatory Data Manager you will ensure data governance rules (master/meta data dictionaries, processes and data flow across multiple applications) are implemented and followed to achieve as well as maintain global data consistency of IDMP related applications and systems (RIMS, xEVMPD, IDMP

 

Who you are:

 

  • At least 5 years of experience from a pharmaceutical industry or service provider with strong business focus
  • At least 3 years in Regulatory Affairs with a knack for data management
  • Excellent data management experience including data governance and master data management
  • In-depth expertise on both regulatory processes for submission of data and documents for medicinal products (e.g. xEVMPD, IDMP, IND, CTA, MAA, lifecycle management) and utilisation of regulatory systems (RIMS, DMS, SAP)
  • Experience in Veeva Vault is a plus
  • Fluent English
  • Work independently, self-motivated
  • Goal-oriented, pragmatic, meticulous working style, high attitude to quality
  • Agile mindset and change oriented
  • Strong service mentality
  • Excellent communication skills

 

 


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 https://jobs.vibrantm.com

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