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Develop and execute regulatory strategies, providing leadership and guidance on pharmaceutical regulatory requirements across India and South Asia to support product registrations, market access, launches, lifecycle management, and post-market compliance.

Monitor QMS performance, conduct GMP training, track quality trends, and drive continuous improvement across plant operations. Sami-Sabinsa Group

To collaborate with internal and external stakeholders like CMC team, supply, commercial, IPR, legal, CROs, Consultants etc to ensure smooth regulatory submissions process

Senior Manager CETA, you will drive Therapeutic Area performance for CDC India by providing strategic trial insights, leading portfolio planning and execution, and ensuring operational excellence across clinical trial activities.

Bachelors degree in medical, Mechanical, Electric Life Science or other healthcare related majors. Set up new process for entering new data - Regulatory Information Management System.

Oversee manufacturing and packaging operations at external manufacturing sites to ensure compliance with current Good Manufacturing Practices and applicable regulatory expectations.

As a subject matter expert, you would be leading the workshop discussions on configurations with concerned business leads, understand & document business requirements. Solution designing, problem solving and working closely with other leads / consultants on a project assignment would be part of core responsibilities in this role.

Accountable for performance and results of Submission Management sub-team team by coordinating and supervising work as a team leader and by monitoring progress, timeliness, completion and quality.

Documentation and Document Control: Manage the complete lifecycle (preparation, issuance, retrieval, and destruction) of all QA documents, including SOPs, Logbooks, BMRs, and BPRs, while maintaining the documentation cell.