Head of Regulatory affairs digital transformation
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Hobson Prior are working with a global leader in pain management who are looking for a Head Of Regulatory Affairs Digital Transformation. This role will be on a permanent bases and will be located in Aachen, Germany.
- To drive the RA Digital Transformation strategy by considering the strategy of major regulators (e.g. EU, US) and developments in automation & robotics.
- To 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 satisfy reporting requirements worldwide, strengthen workflow efficiency, and strengthen data accuracy and integrity
- Monitoring upcoming trends in the regulatory digital environment in relevant markets to ensure that the client is adequately adapting so it remains competitive over time.
- In close collaboration with the Head of RIM & DT, you represent the company 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.
- Leading a team of RA Systems Project Managers and Business Operators.
- Being accountable for pertinent trainings and 1st level support for GRA.
- To have strong project management and negotiation skills.
- Must be flexible, pragmatic, solution-oriented, independent and proactive working style.
- Be able to link long ranging visions/concepts to your daily work.
- To lead, coordinate and synchronize multiple projects, overcome obstacles and be flexible in changing daily workload priorities.
- To require a scientific university degree or equivalent in life science (pharmacy, biology, chemistry or related discipline).
- To have at least 10 years of experience in the pharmaceutical industry or at a health authority.
- Regulatory experience in a global setting, main territorial focus: European Union/US.
- To have 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.
If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.