Parexel is hiring B. Pharma/ M. Pharma as a Regulatory Affairs Associate (WFH) – Apply Now

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Attention B.Pharm/ M.Pharm Graduates: Parexel is Hiring Regulatory Affairs Associate for WFH Positions! Are you ready to delve into the dynamic world of regulatory affairs from the comfort of your home? Join our team and be part of shaping the future of healthcare. Apply today to kickstart your career with a global leader in life sciences consulting!
Position Regulatory Affairs Associate
Qualification B. Pharma/ M. Pharma
Experience Around 2 to 4 years of relevant experience in handling of pre and post approval life cycle management of drug products (small molecules as well as biologics) in various markets.
Salary Competitive

 

Roles and Responsibility

  • Good understanding of regulatory framework, including regional trends, for various types of applications and procedures
  • Contribute to preparation (including authoring where relevant) and delivery of simple, and with experience, increasingly more complex regulatory maintenance submissions from either a global and/or regional perspective.
  • Working knowledge of EU/US regulatory procedures including post approval requirements. Knowledge of ROW markets regulatory legislations would be an added advantage
  • Experience in handling CMC related health authority queries.
  • Good understanding of regulatory framework, including regional trends, for various types of applications and procedures for small and large molecules across all regions as well as knowledge of global pharmaceutical legislation and guidance specifically linked to regulatory CMC aspects in the ICH countries.
  • Preparation and review of Marketing Authorization Applications & Variations for various types of medicinal products (Orals & Parenterals) for filing in EU through different types of procedures (DCP/MRP/National Procedures).
  • Preparation of documentation for different types of Variation procedures like Super grouping,
  • Grouping and Work-sharing to the Marketing Authorizations.
  • Regulatory review of DMFs, batch records, specifications, and stability data to ensure their compliance with the regulatory requirements.
  • Providing regulatory impact assessment for change proposals and identification of required documentation for EU submissions
  • Liaise closely with cross-functional members with aligned product responsibilities.
  • Execute and maintain submission delivery plans, submission content plans, and proactively provide status updates to designated stakeholders.
  • To prepare, review and submit safety variations to Health Authorities and perform post Approval CMC related updates.
  • Working experience in Regulatory Information Management Systems like Veeva Vault.
  • Strong communications skills and ability to guide and mentor team members.
Job Location WFH/ Telangana
Job ID R0000017219
Category Regular/ Consulting
Date Posted 
04/30/2024
Apply Online
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