IQVIA Hiring Regulatory Affairs Officer in Bangalore

Are you a skilled professional in Regulatory Affairs looking for an exciting opportunity in Bangalore? IQVIA, a leading global provider of advanced analytics, technology solutions, and clinical research services, is currently hiring a Regulatory Affairs Officer for its Bangalore location.If you have the qualifications and are ready to advance your career with a top-tier company, this position could be the perfect fit for you.

Job Location and Type

Location: Bangalore, Karnataka
Job Type: Full-Time
Shift: Preferred EU time zone as requested by client.

Key Responsibilities

As a Regulatory Affairs Officer at IQVIA, Your main duties will include:

• Participates in the creation of submission content plans in Regulatory Document Management System or health authority submission portals (e.g., IRIS, CTIS) and monitors progress of the submission
• Authors administrative sections (including cover letters and submission forms) and manages preparation of other documents for routine submissions
  • Examples: investigator submissions, annual reports, PSURs, DSURs, Orphan Drug annual reports, and IND Safety Reports
  • Coordinates activities with other functional groups
• Coordinates submission documents through review cycles and provides guidance for uploading and managing documents in the regulatory submission document management system
  • Supports affiliates as needed
• Coordinates team meetings for major and routine submissions aligned with the GRL and EU/US Regulatory Strategy Leads
• Manages overall completeness of scheduled submissions and coordinates with the Publishing Lead on status of documents and submission timelines
  • Reviews published output
• Participates in operational excellence initiatives (improvement projects)

Qualifications

To qualify for the position of Regulatory Affairs Officer at IQVIA, candidates must meet the following criteria:

• Educational Background: A degree in Life Sciences, Pharmacy, or a related field.
• Skills: Strong understanding of Regulatory Information Management Systems, attention to detail, and the ability to follow defined procedures meticulously.
• Communication: Excellent communication skills to support and train users, as well as to liaise with clients and team members.

How to Apply

Apply now through the link below. Ensure your application showcases your relevant experience and qualifications.

Apply Here

Tagged as: Good Clinical Practice (GCP), Pharmaceutical Jobs