Reg Affairs Officer 2

7 days ago

Bengaluru Karnataka, India IQVIA Full time

**Key Responsibilities and Accountabilities**:

- Including, but not limited to the following_
- 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)

**Time Zone**: Preferred **EU time zone** as requested by client.

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