Job Description
MAIN PURPOSE OF ROLE
The APAC senior regulatory manager supports the APAC RA Director in the daily activities related to product registration, tracking and lifecycle maintenance.
This position ensures that product registrations across APAC countries are progressing according to timelines and supports regulatory compliance throughout the region.
A key responsibility includes monitoring and supporting execution for biosimilar registration plans, providing support and coordination to local RA teams as needed.
In addition, the position leads and executes various region-level projects and consolidations, including but not limited to:
Label Sanity Check Project (Project “Label Guard”)
SIR (Status Information Report) / RP (Registered Position) Improvement Project
Generics (Gx) / Competitor Monitoring
Other ad-hoc surveys and consolidations
MAIN RESPONSIBILITIES
1. Product...
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