Support for developing and implementing the regional regulatory strategy and submission plans for assigned projects/products
Identify supporting documdents required for regional submissions
Write regional and global documentation for submissions, in line with agreed global regulatory strategy, and within agreed timelines
Highlight anticipated and ongoing critical issues arising through the product life-cycle in a timely manner
Lead or provide support to all regulatory related interactions to facilitate and ensure satisfactory resolution of issues
Monitor and react as appropriate to changes in the regulatory environment in assigned regions
Lead or provide input to internal regulatory business initiatives and cross functional work streams
Challenging projects based on your interests and skills
Personal follow-up and clear, transparent communication both before and after commencement of employment
Possibility to follow extra training
Inspiring network events and legendary after work drinks
Strong network of industry leading clients
Expertise within IT, Engineering and Life Sciences
A flying start for every junior, growth opportunities and possibility to share gathered knowledge for more senior employees
Have you got what it takes?
At least 1 year of relevant experience in the pharmaceutical industry
Experience of direct communication and negotiation with regulatory agencies
Fluency in English is a must. French or Dutch are a strong asset.
Reference number: 31729
+32 491 15 34 75
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