Found Description
As a Site Regulatory Associate, you will be responsible for authoring and maintaining Chemistry, Manufacturing, and Controls (CMC) documentation to support global and local regulatory submissions. You will collaborate closely with global and country Regulatory Affairs (RA) teams, ensuring timely filings, managing regulatory queries, and assessing the impact of manufacturing and quality changes. This role is critical in bridging site operations with global regulatory strategies, ensuring compliance while enabling innovation.
Key Responsibilities :
- Author and review CMC sections of regulatory dossiers.
- Support new product filings, variations, renewals, and lifecycle management submissions.
- Partner with global RA teams to align submission strategies and timelines.
- Coordinate with country RA affiliates to meet local regulatory requirements.
- Manage responses to Health Authority queries, liaising with site experts an...