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    Regulatory Affairs Associate

    Teva Pharmaceuticals
    2-5 years
    Prefered by Company
    Kfar Saba
    10 Nov. 20, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./M.Sc./M.Pharm/B.Pharm/Life Science 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

    Who We Are
    At Teva Pharmaceuticals, our mission is to make good health more affordable and accessible, improving the lives of millions worldwide. This mission unites our people across nearly 60 countries, fostering a rich, diverse workplace.

    As the world’s leading manufacturer of generic medicines and a producer of many products on the World Health Organization’s Essential Medicines List, we impact the lives of over 200 million people daily. While proud of this achievement, we constantly seek innovative ways to make a greater difference and welcome new talent to join us in this journey.

    The Opportunity
    The RA Associate II is responsible for compiling and maintaining the CMC (Chemistry, Manufacturing, and Controls) components of medicinal product dossiers (modules 2.3 and 3) for global registrations at Teva.

    How You’ll Spend Your Day

    1. Regulatory Expertise:

      • Participate in registration procedure meetings and provide CMC expertise.
      • Collaborate with Submission RA functions on assigned products.
      • Collect, evaluate, and compile data for inclusion in marketing authorization dossiers.
      • Prepare module 3 and module 2.3 Quality Overall Summary (QoS) for regulatory submissions.
      • Evaluate and ensure the completeness and relevance of dossier content.

    2. Query Management:

      • Respond to queries from regulatory authorities, clients, and internal departments.
      • Coordinate with stakeholders (internal and external) to address CMC questions and follow up on actions.

    3. Regulatory Lifecycle Management:

      • Participate in the change control system and variation process.
      • Classify variations, prepare variation packages, and document changes per regulatory requirements.
      • Contribute to technical data packages and participate in transfer teams when required.

    4. API and Drug Product Support:

      • Assess API regulatory and technical documentation for second API sources or updates.
      • Ensure documentation aligns with required standards for targeted markets.
      • Provide regulatory support to Quality Control and Stability units for specifications and regulatory submissions.

    5. Compliance and Documentation:

      • Stay updated on pharmaceutical industry regulations, including EU, US, and ROW guidelines.
      • Maintain accurate records, update departmental tracking systems, and archive documents.
      • Create and update Site RA SOPs, ensuring training is performed and documented.

    6. Collaboration and Support:

      • Represent Site Regulatory Affairs in project teams.
      • Offer regulatory advice and support to internal departments, affiliates, and clients.

    Your Experience and Qualifications

    • Education:
      • University degree (Master’s degree in Regulatory Disciplines or related field preferred).
    • Experience:
      • 2–5 years in CMC Regulatory Affairs or another scientific role in the pharmaceutical industry.
    • Knowledge:
      • Familiarity with registration procedures, pharmaceutical regulations, and technical dossier requirements.
    • Skills:
      • Strong command of English (spoken and written).
      • Proficiency in IT tools and databases.
      • Effective teamwork and communication skills.

    Why Join Teva?
    In addition to meaningful work, Teva offers a holistic benefits package tailored to support the physical, emotional, and social well-being of you and your family.

    We recognize the importance of balancing professional and personal life and have designed one of the most comprehensive benefits packages in the Israeli market to accompany you throughout your career and life’s milestones.

    Reports To:
    Associate Director, Regulatory Affairs

    Already Working @Teva?
    If you are a current Teva employee, please apply through the internal career site on "Employee Central" for priority consideration. The internal career site is accessible from your home network. For assistance, contact your local HR/IT partner.

    Teva’s Equal Employment Opportunity Commitment
    Teva Pharmaceuticals is dedicated to fostering a diverse and inclusive workplace and provides equal employment opportunities regardless of age, race, creed, color, religion, gender, sexual orientation, disability, or any legally protected status.

    If you require accommodations during the recruitment process, let us know. All provided information will remain confidential and used solely to ensure accessibility for candidates.

    Join us in making a difference—together, at Teva Pharmaceuticals.

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