Manager - Regulatory Affairs (Clinical Trails)

Overview

Manager - Regulatory Affairs (Clinical Trails) to lead and manage end-to-end regulatory submissions and lifecycle activities for clinical trial applications and life cycle management in India.

What you'll do

• Lead assigned products for end-to-end management of regulatory submissions for clinical trial applications and life cycle management.
• Ensure compliance with Indian regulations including NDCT Rule 2019, Drugs & Cosmetics Act 1940 and Rules 1945, and CDSCO requirements.
• Liaise with Global Regulatory Affairs, Medical, Clinical, and Pharmacovigilance to obtain required documentation and support submissions.
• Maintain and manage regulatory information, submissions, and lifecycle activities using regulatory databases and KPIs in Veeva Vault.
• Evaluate regulatory intelligence for risks, compliance impacts, and opportunities, and recommend actions.
• Ensure adherence to company SOPs, regulatory procedures, and documentation standards.

What you'll need

• Bachelor’s degree with specialization in Life Sciences/Pharmacy.
• 8-10 years of job-related experience.
• Skills listed include Regulatory Strategies.
• Skills listed include Digital Fluency.
• Skills listed include Problem Solving.
• Skills listed include Change Management.

Details

• Location: Worli, Mumbai, India (Maharashtra).