Junior Regulatory Associate

We are looking for a Junior Regulatory Associate to join our expanding team. The successful candidate will:

• Be responsible for the review and finalization of Global Regulatory Strategy Documents, CTD sections for IND, CTA, BLA, NDA, and ANDA submissions to ensure effective data presentation as per guidance
• Be responsible for effective co‑ordination with cross functional teams, site, and global Regulatory Affairs teams for the authoring, review, and finalization of dossiers for the pipeline products to ensure effective data presentation and quality
• Prepare quality dossiers for pipeline molecules and supplements to support product launch.
• Monitor and set timelines for filing MA transfers, variations, license renewals, product amendments/supplements, and other product life cycle management activities including annual reports and safety report filing, etc.
• Collaborate with both global and other regional regulatory client team...