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    Senior Regulatory Affairs Associate-Biologics

    Parexel
    4-8 years
    Not Disclosed
    Hyderabad
    10 Sept. 26, 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 Opportunity: Senior Regulatory Affairs Associate

    About This Role:

    We are seeking a Senior Regulatory Affairs Associate with 4-8 years of relevant experience in managing the lifecycle of drug products, including both small molecules and biologics, across various markets.

    Key Responsibilities:

    • Demonstrate a solid understanding of the regulatory framework and regional trends for different application types and procedures.
    • Contribute to the preparation (including authoring when relevant) and submission of regulatory maintenance documents, progressing from simple to more complex submissions from a global and/or regional perspective.
    • Possess working knowledge of EU and US regulatory procedures, including post-approval requirements. Familiarity with ROW market regulations is an advantage.
    • Handle CMC-related health authority queries effectively.
    • Prepare and review Marketing Authorization Applications and variations for various medicinal products (orals and parenterals) for filing in the EU via DCP, MRP, or National Procedures.
    • Develop documentation for various Variation procedures, including Super grouping, Grouping, and Work-sharing for Marketing Authorizations.
    • Conduct regulatory reviews of DMFs, batch records, specifications, and stability data to ensure compliance with regulatory requirements.
    • Provide regulatory impact assessments for change proposals and identify required documentation for EU submissions.
    • Collaborate closely with cross-functional teams aligned with product responsibilities.
    • Execute and maintain submission delivery plans and content plans, providing proactive status updates to stakeholders.
    • Prepare, review, and submit safety variations to Health Authorities and manage post-approval CMC updates as needed.
    • Utilize Regulatory Information Management Systems, such as Veeva Vault.
    • Exhibit strong communication skills and the ability to guide and mentor team members.
    • Work independently while effectively managing responsibilities.

    If you’re ready to take the next step in your career and contribute to our regulatory excellence, we would love to hear from you!

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