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    Senior Regulatory Affairs Associate- Labeling

    Parexel
    3-5 years
    Preferred by Comapny
    India
    10 Nov. 25, 2024
    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: Labeling and Packaging Regulatory Affairs Specialist

    Job Description:

    We are seeking a Labeling and Packaging Regulatory Affairs Specialist with a minimum of 4+ years of experiencein drug development, focusing on labeling, product package coordination, clinical supplies/packaging, supply chain regulatory affairs, or quality. The ideal candidate will have a deep understanding of regulatory requirements and a proven track record in label development and packaging compliance.

    Key Responsibilities:

    1. Labeling Regulations & Development:

      • Extensive experience with labeling regulations and guidance (e.g., CCDS, USPI).
      • Lead and support the development of labeling documents, ensuring compliance with relevant regulations.
      • Research and create comparator labeling documents for submissions.

    2. Annual Reports & Label Updates:

      • Strong understanding and experience in creating annual reports for labeling purposes.
      • Handle post-approval labeling submissions including PSUR (Periodic Safety Update Report)submissions.

    3. Artwork Implementation & Coordination:

      • Collaborate with Tech Operations to ensure effective artwork implementation and alignment with labeling requirements.
      • Coordinate the approval process for printed packaging components to meet design and legislative requirements.
      • Manage and track artwork changes and ensure all components meet the required guidelines and standards.

    4. Document Management Systems:

      • Proficient in SPL (Structured Product Labeling), including all aspects, types, and troubleshooting of SPL submissions.
      • Experience in using electronic document management systems and handling electronic submissions.

    5. Lifecycle Management & Post-Approval:

      • Ensure proper lifecycle management of labeling materials, including managing safety variations, xEVMPD (Extended EudraVigilance Medicinal Product Dictionary), and label artwork updates.

    6. Artwork Tracker Management:

      • Maintain and manage Artwork Trackers & Systems, ensuring that all artwork PDFs are up-to-date and readily available.

    7. Collaboration & Coordination:

      • Liaise with relevant internal teams and external suppliers to assist in the implementation and approval process of labeling and packaging.
      • Ensure all packaging designs and changes are in compliance with legislation requirements for each new product or new packaging.

    Required Skills & Qualifications:

    • Experience: Minimum of 4+ years in drug development with a focus on labeling, product package coordination, or clinical supplies/packaging.
    • Regulatory Knowledge: In-depth understanding of labeling regulations, CCDS, USPI, and experience in packaging compliance.
    • Document Management: Proficiency in using SPL, electronic document management systems, and handling label submissions.
    • Lifecycle Management: Hands-on experience in post-approval labeling, PSUR submissions, and safety variations.
    • Collaboration: Ability to collaborate effectively with internal teams (Tech Ops, Regulatory Affairs) and external suppliers for artwork and packaging development.
    • Trackers & Systems: Expertise in managing Artwork Trackers and ensuring the availability of up-to-date PDF artwork.

    Desired Skills:

    • Experience in handling xEVMPD and managing label artwork updates.
    • Ability to manage artwork approval processes for new and modified packaging.
    • Strong problem-solving skills with the ability to manage multiple projects and deadlines.

    Benefits:

    • #LI-Remote: This position offers remote work flexibility.

    This role provides an excellent opportunity for a Regulatory Affairs Specialist to leverage their expertise in labeling, packaging compliance, and regulatory submissions while contributing to the overall success of the product lifecycle.

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