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    Senior Regulatory Affairs Associate-Biologics

    Parexel
    4-8 years
    Not Disclosed
    Bangalore
    10 Sept. 7, 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: Senior Regulatory Affairs Associate

    Position Overview:

    The Senior Regulatory Affairs Associate is responsible for managing the pre and post-approval life cycle of drug products, including both small molecules and biologics, across various markets. This role requires a deep understanding of regulatory frameworks and the ability to handle complex regulatory submissions. The ideal candidate will have 4-8 years of relevant experience, with a strong grasp of EU/US regulatory procedures and experience with CMC-related health authority queries.

    Key Responsibilities:

    Regulatory Submissions and Maintenance:

    • Preparation and Delivery: Contribute to and, where appropriate, author regulatory maintenance submissions. This includes preparing documentation for Marketing Authorization Applications (MAAs) and variations for oral and parenteral medicinal products in the EU, utilizing various procedures (DCP, MRP, National Procedures).
    • Variation Procedures: Prepare and review documentation for different variation procedures, including Super Grouping, Grouping, and Work-sharing.
    • Post-Approval Updates: Prepare and submit safety variations to Health Authorities and perform post-approval CMC updates as required.

    Regulatory Framework and Procedures:

    • Regulatory Knowledge: Maintain a thorough understanding of regulatory frameworks and trends for both small and large molecules across all regions. Ensure compliance with global pharmaceutical legislation and guidance, particularly related to regulatory CMC aspects in ICH countries.
    • Health Authority Queries: Handle CMC-related queries from health authorities effectively.

    Documentation and Compliance:

    • Review and Assessment: Conduct regulatory reviews of DMFs, batch records, specifications, and stability data to ensure compliance with regulatory requirements.
    • Impact Assessment: Provide regulatory impact assessments for change proposals and identify necessary documentation for EU submissions.

    Cross-Functional Liaison and Project Management:

    • Collaboration: Liaise closely with cross-functional teams to align product responsibilities and ensure effective communication.
    • Submission Management: Execute and maintain submission delivery plans, content plans, and provide proactive status updates to stakeholders.

    Regulatory Information Systems:

    • System Experience: Utilize Regulatory Information Management Systems such as Veeva Vault for managing submissions and maintaining regulatory documentation.

    Skills and Competencies:

    • Communication: Strong verbal and written communication skills with the ability to guide and mentor team members.
    • Independence: Ability to work independently while managing multiple tasks and projects.
    • Attention to Detail: Strong organizational skills with meticulous attention to detail in regulatory submissions and documentation.
    • Problem-Solving: Proficient in analyzing regulatory issues and developing solutions.

    Experience and Qualifications:

    • Experience: 4-8 years of relevant experience in regulatory affairs, with hands-on experience in managing the life cycle of drug products.
    • Knowledge: In-depth knowledge of EU and US regulatory procedures and post-approval requirements. Familiarity with regulatory frameworks in ROW markets is a plus.
    • Education: A degree in a relevant field (e.g., Life Sciences, Pharmacy, or related discipline) is required.

    This role requires a dynamic individual with a comprehensive understanding of regulatory affairs and the ability to manage complex submissions effectively.

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