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    Regulatory Specialist Diagnostics

    Roche
    2+ years
    Not Disclosed
    Budapest
    10 Jan. 2, 2025
    Job Description
    Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Job Title: Regulatory Specialist
    Location: Budapest, Hungary
    Category: Regulatory Affairs

    About Roche:
    At Roche, we believe that diversity, equity, and inclusion are essential to success in healthcare on a global scale. Embracing individuality allows us to better understand and meet the varied healthcare needs of the communities we serve. Join Roche, where every voice matters, and together we share a passion for exceptional care.

    The Position:
    As a Regulatory Specialist, you will play a critical role in ensuring the successful registration and compliance of products throughout their lifecycle. You will compile regulatory documents, deliverables, and support product registration timelines. This role involves collaborating with internal stakeholders, health authorities, external partners, and other teams to secure regulatory approvals and maintain product documentation in accordance with applicable regulations.

    Key Responsibilities:

    • Provide regulatory support for marketed products, including labeling, product and manufacturing changes, and compliance documentation.
    • Interface with internal stakeholders to gather data and prepare, maintain, and update regulatory documentation.
    • Maintain product technical files and ensure compliance with global regulatory directives.
    • Support the management of the Regulatory Information Management System (RIMS), including the creation and maintenance of product information.
    • Assist with international regulatory submissions, including answering health authority queries and providing necessary documentation.
    • Support ongoing activities related to compliance and regulatory reporting, including annual and laser reporting in relevant countries.
    • Collaborate with cross-functional teams to ensure successful regulatory submissions and approvals.

    Who You Are:
    We are looking for a self-motivated individual with a passion for regulatory affairs. Ideal candidates will have:

    • A Bachelor’s/Master’s degree or equivalent experience in Regulatory Affairs, R&D, Quality, Operations, or Clinical fields.
    • 0-5 years of experience in Regulatory, R&D, Quality, Operations, or Clinical settings. Equivalent experience, such as training as a laboratory technician, is also considered.
    • Strong autonomy and the ability to work independently.
    • Fluency in English (German is a plus).
    • Excellent attention to detail, organizational skills, and the ability to manage multiple priorities.

    In Exchange, We Offer:

    • Development opportunities: Roche provides abundant learning resources, free language courses, training, and the chance to shape your own career through internal position changes and international assignments.
    • Benefits & Flexibility: Competitive salary, cafeteria package, annual bonus, private medical services, Employee Assistance Program, and much more. Enjoy flexibility with home office options (2 office days per week) and fully remote working conditions within Hungary.
    • Global Diverse Community: Join a team where cooperation, learning from each other, and sharing successes are integral to our culture. Roche’s leadership is committed to creating an inclusive environment where your voice is heard.

    Please Note:
    This position is part of a Talent Pool for future recruitment opportunities and may not reflect an active opening but aims to build a network of qualified candidates for future roles.

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