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CMC Specialist Location: Hamburg, Germany - Oferta z Jobs.pl

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CMC Specialist Location: Hamburg, Germany

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  • CMC Specialist
    Location: Hamburg, Germany
    Type: Contact, 3 days per week (office based, with home working available after initial period)
    Rate: Upto €95.00 per hour (negotiable on experience)

    A new contract opportunity has arisen within a company located in North Germany who require CMC Specialist to join their team on a part time basis. The successful candidate will provide expert Regulatory advice and carry out projects as necessary within Regulatory Affairs and liaise with Regulatory authorities throughout Europe.

    Your Responsibilities will include though not be limited to:

    - Working closing with authors of dossier sections
    - Prepare, Review and Approve CMC Regulatory filing to health authorities
    - Provide Regulatory guidance to product teams


    - At least 5 years experience within CMC
    - Experience in Regulatory CMC (Module 3 and 2.3)
    - Experience with document management tools
    - Excellent verbal and written English

    Keywords: Regulatory Affairs, CMC, Module 3, Module 2.3, Dossier Update. Document management, Contract, Part-time, Germany.


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