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RA Expert
Brussel
Job description
- 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
Benefits
- 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?
Apply- At least 1 year of relevant experience in the pharmaceutical industry
- Registration experience
- 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
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