Opportunity to work as Regulatory Affairs Associate at PAREXEL

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
• For more articles, Kindly Click here.

  For pharmaceutical jobs, follow us on LinkedIn

  For more jobs, kindly visit our job section.

  www.pharmaceuticalcarrier.com/Jobs