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    Senior Regulatory Affairs Associate - Biologics

    Parexel
    1-4 years years
    Not Disclosed
    Bangalore
    10 July 11, 2024
    Job Description
    Job Type: Full Time Education: BSC, MSC, B Pharma, M Pharma, Pharma D, Nursing 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 Vacancy: Senior Regulatory Affairs Associate - Biologics

    Location: Bengaluru, India
    Additional Locations: Hyderabad, Telangana

     

    Overview

    As part of Parexel Consulting, you will play a vital role in helping biopharmaceutical and medical device companies navigate the complex and ever-changing regulatory landscape. Drawing on your scientific, technical, and regulatory expertise, you will work closely with clients to develop and implement regulatory strategies that bring their products to market faster and keep them there.

    We value collaboration, innovation, and continuous learning. As a member of our team, you will partner with a diverse group of clients, and be exposed to various product types and therapeutic areas. You will also develop your skills through challenging assignments and mentorship from experienced regulatory professionals. Plus, you will enjoy the flexibility of working remotely while still being part of a supportive and dynamic team.

     

    Success Profile

    To succeed at Parexel, you should possess the following soft skills and interpersonal traits:

    • Communicator
    • Detail-oriented
    • Problem-solver
    • Relationship-builder
    • Results-driven
    • Strategic

     

    About This Role

    Position: Senior Regulatory Affairs Associate

    Experience:

    • 4-8 years of relevant experience in handling pre and post-approval lifecycle management of drug products (small molecules and biologics) in various markets.
    • Good understanding of regulatory frameworks, including regional trends, for various types of applications and procedures.
    • Experience in handling CMC-related health authority queries.
    • Working knowledge of EU/US regulatory procedures, including post-approval requirements.
    • Knowledge of ROW markets regulatory legislation is an advantage.
    • Experience with Regulatory Information Management Systems like Veeva Vault.

     

    Key Responsibilities:

    • Contribute to preparation (including authoring where relevant) and delivery of regulatory maintenance submissions from either a global and/or regional perspective.
    • Preparation and review of Marketing Authorization Applications & Variations for various types of medicinal products (Orals & Parenterals) for filing in the EU through different procedures (DCP/MRP/National Procedures).
    • Prepare documentation for different types of Variation procedures like Super grouping, Grouping, and Work-sharing to the Marketing Authorizations.
    • Conduct regulatory reviews of DMFs, batch records, specifications, and stability data to ensure compliance with regulatory requirements.
    • Provide regulatory impact assessment for change proposals and identify required documentation for EU submissions.
    • Liaise closely with cross-functional members with aligned product responsibilities.
    • Execute and maintain submission delivery plans and submission content plans, and proactively provide status updates to designated stakeholders.
    • Prepare, review, and submit safety variations to Health Authorities and perform post-approval CMC-related updates.
    • Maintain and expand local and international regulatory knowledge within the clinical industry.
    • Develop knowledge of regulatory procedures within other Parexel functional areas.
    • Provide relevant training and mentorship to staff and project teams.

     

    Skills and Knowledge:

    • Strong communication skills and the ability to guide and mentor team members.
    • Excellent organizational skills and the ability to manage competing priorities.
    • Strong project management skills.
    • Detailed knowledge of global pharmaceutical legislation and guidance specifically linked to regulatory CMC aspects in the ICH countries.

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