Senior Manager Regulatory Affairs (m\f) Job type: Permanent Salary: Flexible + great benefits package Location: Munich, with flexible working from home
-Are you interested in leading the creation and implementation of regulatory strategy? -Have you got PIP"e;s experience or looking to gain some experience in this area? -Would you like to work for a renound pharmaceutical company with clear routes for progression? Job reference: J24205 One of the worlds leading pharmaceutical companies based in Munich are now looking for a Senior Regulatory Affairs Manager to join the EU department and play a pivotal role in regulatory guidance and strategy for assigned products.
Key tasks: - Be the represntive for the Regulatory function in cross-functional teams to provide Regulatory guidance and input into strategy - Lead the preparation and submission of documents during drug development and lifecycle management. - Be the Point of Contact for Health Authorities including the EMA and National bodies, as well as external partners and in-house functions - Support the creation of SOPs
Key requirements: - 5+ years' Regulatory Affairs experience, primarily in EU-focused drug development and MAAs - Paediatric clinical development experience would be a plus - Health Authority interaction experience, ideally with National bodies and EMA - Experience in cardiovascular and metabolism would be desirable
Remember if this role is not suitable for you or you are no longer looking for a new job please feel free to forward this to anyone you feel would be suitable. If we successfully find a role for your recommendation we will give you £250 in vouchers of your choice. Key words: Regulatory, Senior Manager, Regulatory Senior Manager, CTAs, MAAs, Clinical, drug development, PIPs, paediatric, strategy, Germany, Munich, Bavaria