Regulatory Affairs Associate Senior 5-7Yrs

Job Description Description :

Responsible for publishing, reviewing, archiving, and dispatching eCTD, NeeS or paper regulatory submissions for Devices & Drugs Submissions.

• Manage and lead regulatory publishing operations for global submissions.
• Ensure submissions meet the global eCTD requirements and other regional formats (NeeS, paper).
• Coordinate with a cross functional team including Regulatory Affairs, CMC, Quality and Clinical team to plan submission strategy and timelines.
• Oversee and ensure timely publishing and dispatch of regulatory submissions using various publishing tools (e.g. Veeva Vault RIM, eCTDXpress, Extedo, Lorenz).
• Perform quality control checks of published submissions to ensure technical and formatting compliance.
• Should have expertise in health authority gateways for submission dispatch i.e. ESG, MHRA portal, CESP, EMA portal.
• Implement and maintain publishing SOPs, work instructions, and quality standards.
• Develop training programs and mentor junior team members.

Qualifications :