Senior Specialist, RA Operations

**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 RESPONSIBILIT...