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ema regulatory strategy eu regulatory hta post-marketing📋 Description
- Develop European regulatory strategy aligned with Global plan for assigned products.
- Independently execute Europe filing plans per objectives.
- Ensure high-quality EU submissions are timely and compliant.
- Advise on EU CTR submissions with Regulatory Study Lead.
- Provide direction on regional/local regulatory mechanisms within GRT.
- Oversee EU launch and post-marketing activities; hybrid work.
🎯 Requirements
- 10+ years in European regulatory affairs with EMA experience.
- Degree: BSc or PharmD/PhD; English fluent; other EU languages a plus.
- Proven MAAs through EMA centralized procedure and national agencies (incl. UK/CH).
- Strong experience leading/regulatory agency interactions.
- Solid scientific foundation; strong teamwork and communication.
- Excellent planning, organization, and multi-project prioritization.
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