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Regulatory Expert, Winterthur area - Medical Devices - Oferta z Jobs.pl

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Regulatory Expert, Winterthur area - Medical Devices

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  • Regulatory Expert, Winterthur area - Medical Devices

    Are you a Regulatory Expert with strong experience within a pharmaceutical industry and looking for a new challenge?

    Then why don't you look further at what we can offer you and apply now:

    On behalf of our client, an international company specialized in medical devices based in Winterthur area, we are looking for a Regulatory Expert with fluent English skills (German will be a big asset). It is a contracting position starting ASAP until end of March 2017 with option to extend.

    In this position the Regulatory Expert will perform and support the following activities to ensure regulatory filing compliance as a basis to support the business:

    • Active Substance master File, Drug Master File, Certificate of Suitability (CEP) submissions (incl. coordination and preparation for new submissions, regular updates, variations & renewals
    • Customer communication (ie prior and after submission of regulatory filings and/or filing updates filing)
    • Coordination and preparation of responses to deficiency letters or authority requests
    • 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
    • Preparation of FDA-GDUFA (Generic Drug User Fee Amendments) applications
    • Ensure regulatory filing compliance and continued life cycle management
    • Partner with Production, Chemical and Analytical Development, Quality Control, Quality Assurance and other departments as needed

    You bring to this role:

    • A Bachelor's degree with 6 + years' experience in highly regulated environment (preferably within the pharmaceutical industry)
    • Regulatory CMC or CMC experience is preferred
    • Basic knowledge of regulatory requirements is a big advantage
    • Drug development experience is preferred
    • Working knowledge of global HA laws, regulations and guidance is required
    • Experience in developing regulatory strategies in addition to a good understanding of product development is highly preferred
    • Solid understanding of chemistry relevant is an advantage
    • Demonstrate ability to communicate regulatory requirements is required
    • Excellent communication skills with fluency in English and German is considered as an advantage
    • Good organizational and interpersonal skills

    I'm always looking for Regulatory Expert so please don't hesitate to send me your CV.


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