LifeScience Regulatory Svs Associate

Overview

LifeScience Regulatory Svs Associate focused on regulatory operations and lifecycle submission work for life sciences.

What you'll do

• Perform regulatory operations tasks like bookmarking and hyperlinking for granular submission documents following ICH guidelines and other health authority requirements.
• Transform source documents and complete quality control checks for submission components.
• Collect, collate, and evaluate scientific data gathered as part of R&D.
• Advise on legal and scientific restraints and requirements.
• Help ensure products comply with current regulations.
• Support end-to-end planning, coordination, compilation, publishing, and dispatch of global regulatory lifecycle submissions.

What you'll need

• Primary skill: Life Sciences Regulatory Affairs (P1 roles).
• Master of Pharmacy (M.Pharm) as a qualification.
• 1 to 3 years of experience.
• Experience managing regulatory dossiers and submission packages for eCTD and regional requirements.
• Ability to manage submission timelines, lifecycle activities, renewals, variations, supplements, annual reports, and post-approval changes.
• Use Regulatory Information Management Systems (RIMS), publishing tools, and quality review processes.

Details

• Location: Bengaluru, India.