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Pharmaceutical Regulatory Expert - Oferta z Jobs.pl

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Pharmaceutical Regulatory Expert

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  • Regulatory Affairs Specialist

    Dear Regulatory Affairs Specialist,

    I'm on the hunt for a Regulatory Affairs specialist to join my international pharmaceutical client in Schaffhausen until March 2017 with a possibility for extension.

    In this regulatory function you will perform and support the following activities to ensure regulatory filing compliance:

    • Active Substance Master File, Drug Master File, Certificate of Suitability (CEP) Submissions:
    • Coordination and preparation for new submissions, regular updates, variations, renewals
    • Customer communication (prior and after submission of regulatory filings and/or filing updates filing)
    • Collaboration with customers to develop and align regulatory filing strategies and implementation plans
    • Coordination and preparation of responses to deficiency letters or authority requests
    • Coordination and preparation of responses of customer requests related to filings and or other regulatory/technical questions or questionnaires
    • Preparation and submission of Open Parts, Letter of Access, TSE Statement, Kosher/Halal Statement, Allergens Statement, Melamin free Statement, Latex free Statement, etc.)
    • Regulatory assessments of Change Requests and development of regulatory implementation plan
    • Regulatory assessment of major Non Conformances
    • Regulatory consultation for Quality Assurance, Production, Quality Control, Sales, Purchasing
    • Preparation of FDA-GDUFA (Generic Drug User Fee Amendments) applications
    • Regulatory support for inspections and audits
    • Ensure regulatory filing compliance and continued life cycle management


    • A minimum of a Bachelor's degree with a minimum of 6+ years of relevant experience in a highly regulated environment (preferably pharmaceutical industry) or an advanced degree (MS, PhD, etc.) with a minimum of 4+ years of experience is required.
    • Regulatory CMC or CMC experience is preferred.
    • Good knowledge of English.
    • Basic knowledge of regulatory requirements is preferred.
    • Drug development experience is preferred.
    • A working knowledge of global HA laws, regulations, and guidance is required.
    • Experience developing regulatory strategies and an understanding of product development is preferred.
    • Solid understanding of chemistry relevant is preferred.
    • Knowledge in German is preferred but not absolutely required

    If you're up for a new role and fulfil the requirements, click on the apply button!

    I look forward hearing from you


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