Are you a senior regulatory affairs specialist based in Basel?
Do you have experience leading a large global team?
Are you looking for an exciting new opportunity working for one of the largest Pharmaceutical Companies in the world?
If this sounds like a good fit for you apply below!
Brief overview of responsibilities:
* Leads the regulatory lifecycle management and portfolio expansion function (total headcount approx. 180 across, 5 global locations)
* Directs the function to efficiently implement post approval variations to implement manufacturing changes, process improvement and compliance initiatives
* Directs the function to provide timely risk assessment and dossier provision for geographic and portfolio expansion of established products worldwide
* Drives operational excellence and transformation initiatives to optimize department performance
* Represents Company in appropriate industry forums, engages in external lobbying activities and maintains effective relationships with key regulatory agencies worldwide.
* As a key member of the Global Regulatory Affairs leadership team actively contribute to the overall strategic direction of the GRA function
* Experienced in operating effectively at senior executive level
* Advanced leadership skills; sets clear vision and directions and aligns teams. Motivates and develops teams to achieve excellent performance. Ability to perform under pressure in a fast paced environment.
* Robust knowledge of global regulatory affairs and manufacturing/QA fundamentals
* Solid knowhow of project management techniques.
* Proven track record in organizational transformation and change management
* Demonstrated successful experience working in interdisciplinary teams in a complex matrix
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