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Senior Manager Regulatory Affairs (m/f) - Oferta z Jobs.pl

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Senior Manager Regulatory Affairs (m/f)

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  • 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


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