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    Regulatory Program Manager

    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 Affairs Specialist
    Location: Budapest, Hungary
    Category: Regulatory Affairs

    About Roche:
    At Roche, we are committed to fostering diversity, equity, and inclusion in everything we do. We believe that embracing individuality and inclusivity is key to understanding and meeting the healthcare needs of the global community. Join Roche, where every voice matters and where we share a passion for delivering exceptional care.

    The Position:
    As a part of our Regulatory Affairs team, you will work closely with the Submission Management Group (SMG) in Pharma Technical Regulatory (PTR) to manage the preparation and submission of regulatory documents for our global pharmaceutical operations. This role focuses on compiling and maintaining regulatory dossiers, ensuring adherence to the Common Technical Document (CTD) standards and Roche's Chemistry, Manufacturing, and Control (CMC) guidelines.

    Key Responsibilities:

    • Maintain regulatory documents in systems such as RIM, Documentum, and SharePoint.
    • Prepare, update, and format regulatory documents according to PTR product manager or submission manager instructions.
    • Compile and format regulatory dossiers for publishing and submission.
    • Conduct data entry into global regulatory systems, perform trend analysis, and generate relevant metrics.
    • Collaborate with PTR product managers and internal partners to ensure smooth project execution.
    • Actively participate in ongoing RSS and PTR initiatives.

    Who You Are:
    We are looking for a self-motivated individual who is passionate about regulatory affairs and has a commitment to providing high-quality service. Ideal candidates will have:

    • 2-5 years of experience in a similar role, preferably within the pharmaceutical industry.
    • A BA or BS degree in biology, chemistry, pharmacy, or a related field.
    • Expertise in IT tools including Word, Excel, Acrobat, and experience with Documentum and SharePoint.
    • Strong attention to detail, particularly in formatting, style, and layout of technical documents.
    • Ability to collaborate effectively in cross-functional, international teams.
    • Strong organizational, time-management skills, and the ability to work under pressure and independently.
    • Fluent in both written and spoken English.

    In Exchange, We Offer:

    • Development opportunities: Access to Roche’s learning resources, language courses, training, and international assignments. Shape your career with internal position changes and mentoring programs.
    • Benefits & Flexibility: Competitive salary, cafeteria package, annual bonus, private medical services, Employee Assistance Program, and more. Enjoy flexible working conditions, including home office (2 office days per week), and the possibility of fully remote work within Hungary.
    • Global Diverse Community: Join a team where cooperation, debate, and shared successes are key. Roche’s leadership is committed to creating an inclusive culture where your voice is heard.

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

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