Opportunity to work as Regulatory Affairs Associate at PAREXEL




PAREXEL is known for its significant contributions to the bio-tech and pharmaceutical industries, offering a wide range of services to support the development of new drugs and treatments on a global scale. Their expertise in contract research, medical communications, and consulting spans various therapeutic areas and serves pharmaceutical, biotechnology, and medical device companies worldwide.

Regulatory Affairs Associate

Job Description

Key Responsibilities at PAREXEL

  • Regulatory Framework Understanding: Gain expertise in regulatory affairs, particularly in CMC (Chemistry, Manufacturing, and Controls), and adapt to EU shifts.
  • Global Regulatory Insight: Stay updated on regional regulatory trends, encompassing small and large molecules, across different geographical regions.
  • Documentation Expertise: Provide regulatory guidance on procedural and CMC document requirements as specified by Health Authorities for assigned tasks, including:
    • Submission strategy
    • Document review
    • Analysis of regulatory procedures and special designations throughout product development, authorization, and extension phases.
  • Collaborative Engagement: Work closely with cross-functional team members sharing product responsibilities.
  • Submission Management: Develop, execute, and maintain submission delivery plans and content plans, while proactively updating stakeholders on progress.
  • Dossier Authoring: Write dossier sections based on changes to approved MAA (Marketing Authorization Application).
  • Change Evaluation: Apply knowledge of change evaluation according to country-specific guidelines.
  • Lifecycle Management: Experience in overseeing lifecycle activities in EU markets is preferred.
  • CTD Compliance: Possess knowledge of Common Technical Document (CTD) guidelines.

Additional Information

  • Job ID: R0000013325
  • Location: Bengaluru
  • Industry Type: Pharma / Healthcare / Clinical research
  • Application Deadline: 30th October 2023
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To apply for this job please visit jobs.parexel.com.