2 weeks ago

Head Global Regulatory Affairs Digital Transformation (m/f/d)

AC TBC Permanent

Have a look at the fulfilling work on offer:

  • You drive the RA Digital Transformation strategy by taking into account the strategy of major regulators (e.g. EU, US) and developments in automation & robotics.
  • You establish and drive execution of a set of projects and programs ensuring access to cost-effective, state-of-the-art technology platforms/solutions with demonstrated added value that 1. satisfy reporting requirements worldwide, 2. strengthen workflow efficiency, and 3. strengthen data accuracy and integrity 
  • You monitor upcoming trends in the regulatory digital environment in relevant markets to ensure that Grünenthal is adequately adapting so it remains competitive over time.
  • In close collaboration with the Head of RIM & DT, you represent Grünenthal at EFPIA and at other relevant industry forums on regulatory technology. 
  • You are responsible that the landscape of IT applications within GRA is fit-for-purpose (e.g. publishing, regulatory databases, document management systems, electronic submission portals), to ensure data integrity and business continuity through appropriate working processes.
  • You lead a team of RA Systems Project Managers and Business Operators.
  • You are accountable for pertinent trainings and 1st level support for GRA.

Let your talent flourish:

  • You have a scientific university degree or equivalent in life science (pharmacy, biology, chemistry or related discipline).
  • You have at least 10 years of experience in the pharmaceutical industry or at a health authority.
  • You have regulatory experience in a global setting, main territorial focus: European Union/US.
  • You have a profound knowledge of the regulatory operations & systems space.
  • You have excellent English communication skills, both written and verbal, German and Spanish are beneficial.
  • You are able to work in a matrix environment.
  • You have strong project management and negotiation skills.
  • You have a flexible, pragmatic, solution-oriented, independent and proactive working style.
  • You are able to link long-ranging visions/concepts to your daily work.
  • You are able to lead, coordinate and synchronize multiple projects, overcome obstacles and be flexible in changing daily workload priorities.            
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