Job Summary

Sr Regulatory Associate (CMC- EU, APAC, Gulf Countries)

Job Responsibilities

For non-complex submissions, independently fulfill the following responsibilities. For complex submissions, fulfill the following responsibilities under supervision and with guidance from more senior regulatory colleagues:

- Prepares and submits full application or components of IND, marketing and lifecycle maintenance applications to ensure compliance with government acts and regulations.
- Undertakes information processing activities with extremely high reliability at high quality and in tight timelines according to standard processes and operating procedures.
- Undertake project specific activities with minimal supervision from senior colleagues within cost and time estimates/contracts.
- Preparation of records and/or logs and maintenance or update of regulatory databases as per Syneos Health and/or client requirements.
- Conducts Quality Control reviews of documents and sends out for review, tracks until final submission or delivery to client.




- Attends client meetings as needed and builds client relationship in support of projects and deliverables.
- Systematically reviews Regulatory Associates or other Senior Associate s work, performance, and productivity tracking, coordinating with project manager and director for coordination of the project.
- Identifies risks to project delivery related to own workload and appropriate escalation. For identified non-complex issues, provide proposals for issue resolution.
- Assists in training and mentoring of team members depending upon project requirements.
- Maintenance of individual training records (Syneos Health or client related) and completion of all designated required training.

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.

📌 Sr Regulatry Associate (CMC- EU,APAC, gulf countries) (India)
🏢 Syneos Health
📍 India