- Being the RA ambassador for the Netherlands
- Interaction with authorities
- Team work with your international colleagues to maintain the global regulatory strategy
- Manage 1 FTE directly
My client is a major pharmaceuticals organization with worldwide subsidiaries. With 40 000 FTE's and present in healthcare, digital & wellness.
- Being the dedicated contact to the external stakeholders
- Ensure the continuous communication towards the team when dealing with regulatory affairs
- Work closely with RA team in Benelux and France
- Take ownership on RA projects with settling KPI's to ensure the stragetic delivery of the pipeline
- Manage a complex and diverse set of registration/regulatory requirements across multiple markets and brands to enable the strategic delivery of a global pipeline.
- Contribute to the regulatory strategy to enable successful registration in global markets with a focus on new product development
- Maintain and develop knowledge and intelligence across the Regulatory Function to build 'right first time' approach with respect to registrations globally.
- Collaborate with partner functions to agree market specific data requirements and delivery timelines
- Develop excellent working relationships with local (regional) regulatory colleagues to facilitate aligned regulatory plans and shared learnings to ensure efficient speed to market.
- Create strong and proactive relationships with all partner functions.
- Healthcare & Life Sciences educated - from Bachelor
- Experienced in Regulatory Affairs in pharmaceuticals
- Management experience
- Involved with new product launch and registrations
- Used to work on an international environment with international teams and authorities
- Global vision of RA practices, rules, guidelines, variations and renewals
- PDCA cycle may of working: deliver on time, do, check and according to cost and quality standards
- Fluent in Dutch and English, others is definitely an asset
- Competitive salary
- Possibility to grow within the organization locally or internationally