Technical Associate - Regulatory affairs

Summary

With a startup spirit and 90,000+ curious and courageous minds, we have the expertise to go deep with the world’s biggest brands—and we have fun doing it. Now, we’re calling all you rule-breakers and risk-takers who see the world differently, and are bold enough to reinvent it. Come, transform with us.

Are you the one we are looking for?

We are inviting applications for the role of Technical Associate, “3014 Mailbox- Regulatory affairs”.

The person will be responsible for maintaining the mailbox where requesters send Regulatory requests for CMC only filings and creates/Submits Submission Planning and Archival Request to Publishing.

Responsibilities:

• Maintains the Outlook mailbox where requesters send Regulatory requests for CMC-only filings.
• Serves as the triage contact for Right-First-Time submission requests and processes.
• Creates/Submits Submission Planning and Archival Request to Publishing.
• Maintains the master list of all activities associated with these requests by entering assignments into the workload spreadsheet for tracking and throughput.
• Flexibility in responding to changing priorities or dealing with unexpected events.
• Provides operational and strategic input.
• Provides tactical “hands-on” support as well as mentorship and oversight of the India-based Submission Coordinators.
• Provides operational and strategic input into the development and optimization of business processes, which will contribute to continuous improvement and optimization of the current process.

Qualifications we seek in you!

Bachelor's or Master’s degree preferable in Pharmacy required in Biological science or related field (advanced degree preferred).