JOB TITLE:
Senior Regulatory Affairs Associate, Global eCTD Operations
EXEMPTION STATUS:
Exempt
POSITION LEVEL:

JOB CODE:

JOB GRADE:

JOB FAMILY:
SA-Regulatory Affairs
VERSION:

PURPOSE AND SCOPE:
The Senior Regulatory Affairs (RA) Associate, Operations, plays a critical role in the planning, preparation, and management of global electronic Common Technical Document (eCTD) submissions that support the approval and maintenance of licensed pharmaceutical products worldwide.

This position ensures full compliance with global electronic submission requirements, including those of the U.S. FDA, EMA, China NMPA, Health Canada, LATAM, and other regulatory authorities and contributes to continuous improvement of global submission standards, systems, and processes within the Regulatory Affairs Operations function..
PRINCIPAL DUTIES AND RESPONSIBILITIES:
- Serve as a subject matter expert (SME) in global eCTD publishing and submission management, ensuring compliance with regional regulations and technical requirements (U.S., EU, China, APAC, LATAM).
- Lead the preparation,



compilation, quality check, validation, and delivery of high-quality global regulatory submissions using eCTD and related formats.
- Collaborate cross-functionally with Global and Local Regulatory Affairs teams to ensure timely, accurate handoff and harmonization of submission components across regions.
- Apply deep understanding of global eCTD structure, lifecycle management, and validation standards to troubleshoot and resolve technical issues.
- Interpret and implement evolving global eCTD and electronic submission guidance, proactively ensuring readiness for current regulatory initiatives and format updates.
- Develop, maintain, and enhance departmental templates, standards, and workflows for electronic submissions and regulatory information systems.
- Manage submission content in accordance with company policies, ensuring data integrity, version control, and compliance across all submission types (IND/CT

📌 Senior Specialist, RA Operations (Bengaluru)
🏢 Fresenius Medical Care
📍 Bengaluru