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    Senior Regulatory Affairs Associate-Biologics

    Parexel
    4-8 years
    Not Disclosed
    Hyderabad
    10 Sept. 5, 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

    Senior Regulatory Affairs Associate

    Position Overview:

    We are seeking a Senior Regulatory Affairs Associate with 4-8 years of experience in the management of drug product life cycles, including both small molecules and biologics, across various markets. The ideal candidate will have a solid understanding of regulatory frameworks, regional trends, and the requirements for pre- and post-approval submissions.

    Key Responsibilities:

    • Regulatory Submissions:

      • Contribute to the preparation and delivery of regulatory maintenance submissions, ranging from simple to increasingly complex, from both global and regional perspectives.
      • Author and review documentation for Marketing Authorization Applications (MAAs) and Variations, ensuring compliance with EU procedures such as DCP, MRP, and National Procedures.
      • Prepare documentation for various Variation procedures, including Super Grouping, Grouping, and Work-sharing for Marketing Authorizations.
      • Manage post-approval CMC-related updates and safety variations, ensuring timely submission to Health Authorities.

    • Regulatory Framework and Compliance:

      • Demonstrate a thorough understanding of regulatory frameworks and trends for small and large molecules across all regions.
      • Handle CMC-related health authority queries and ensure compliance with global pharmaceutical legislation and guidance, particularly ICH requirements.
      • Review DMFs, batch records, specifications, and stability data to ensure regulatory compliance.

    • Cross-Functional Collaboration:

      • Liaise closely with cross-functional teams to align on product responsibilities and regulatory requirements.
      • Provide regulatory impact assessments for change proposals and identify necessary documentation for EU submissions.
      • Execute and maintain submission delivery plans and content plans, providing proactive status updates to stakeholders.

    • Regulatory Information Management:

      • Utilize Regulatory Information Management Systems, such as Veeva Vault, to manage and track submissions and regulatory activities.

    • Team Leadership:

      • Mentor and guide team members, leveraging strong communication skills to foster collaboration and ensure adherence to regulatory processes.

    Qualifications:

    • Experience: 4-8 years of relevant experience in regulatory affairs, handling both pre- and post-approval life cycle management for drug products (small molecules and biologics).
    • Knowledge:
      • In-depth understanding of EU and US regulatory procedures, including post-approval requirements.
      • Familiarity with regulatory frameworks in ROW markets is a plus.
      • Expertise in regulatory CMC aspects and global pharmaceutical legislation, particularly within ICH countries.
    • Skills:
      • Proficiency in Regulatory Information Management Systems like Veeva Vault.
      • Strong communication and leadership skills, with the ability to mentor and guide team members effectively.
    • Education: Relevant degree in life sciences or a related field.

    This role offers the opportunity to make a significant impact within a dynamic regulatory environment while advancing your career in a supportive and collaborative setting.

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