executive director pharmaceutical compliance - Siena (si) - beBeeregulator

    beBeeregulator
    beBeeregulator Siena (si)

    19 ore fa

    A tempo pieno

    Titolo del lavoro: Regulatory Specialist And Senior Specialist

    Descrizione

    Senior Regulatory Affairs Specialist

    We are seeking a highly motivated and qualified Senior Regulatory Affairs Specialist to join our team.


    The ideal candidate will report to the Regulatory Affairs Manager and provide support in formulating and implementing regulatory strategies for product development, collaborating closely with internal departments. Key responsibilities include:

    • ​Developing content, timelines, and contingencies for submissions with cross-functional contributors,​ensuring timely approval of products from government agencies worldwide.

    • ​Gathering, evaluating, and organizing information necessary for regulatory submissions;​alidating submission quality against corporate goals. Ensuring compliance with local laws
      and regulations is also crucial.
    Requirements:
    ,

    At least 5 years' experience inregulatory affairs is mandatory. Prior experience with Regulatory Life Cycle Management(RCLM) or eCTD systems would be beneficial.The successful applicant must have an excellent understanding of ICH GCP guidelines globally (particularly FDA / EMA), as well as exceptional written / oral communication skills., A thorough knowledge of pharmaceuticals industry standards;

    A valid level of English language proficiency - both written & spoken.
    The right individual will receive a competitive salary proportional to their experience which comes along
    personal benefits offered by the organization , Working environment designed particularly not onlyto meet but far surpass expectations!, We look forward to your application from interested candidates who authorize processing personal data according Legislative Decree no 196/03 we appreciate every effort you dedicate towards making us one best companies out there


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