Senior Associate - Regulatory Affairs

Overview

Associate/Senior Associate role in Regulatory Affairs managing regulatory events, submissions and data within Veeva Vault RIM for ClinChoice clients.

What you'll do

• Review and manage all regulatory events (changes) initiated within the Veeva Vault RIM system.
• Perform system impact assessments for regulatory changes and ensure accurate documentation of outcomes.
• Create and maintain regulatory Activities, Regulatory Objectives, Submissions, Global Content Plans, and associated records.
• Ensure proper linkage and completeness of Event Details, Change Items, and Label Concepts within the system.
• Support CMC Product Strategists, Labelling Leads, and Country Regulatory Strategists through strategic and operational regulatory support.
• Assist in the lifecycle management of regulatory submissions and registrations across multiple regions.
• Track submission timelines and regulatory milestones, and ensure adherence to global submission schedules.
• Monitor regulatory workflows, submission tracking, and health authority interactions.
• Manage and maintain regulatory data within the Veeva Vault RIM.
• Perform data entry, validation, reconciliation, and quality control checks to ensure high data accuracy and completeness.
• Collaborate with cross-functional stakeholders to gather and define data requirements aligned with business processes and regulatory needs.
• Analyse regulatory datasets to identify trends, inconsistencies, and operational gaps.

What you'll need

• Bachelor's or master's degree in B. Pharm, M. Pharm, Pharm.D, B.Sc (Life Sciences), M.Sc (Life Sciences), Biotechnology, Biochemistry, or other Life Sciences disciplines.
• 3–5 years of relevant experience in RIM, preferably with hands-on exposure to Veeva Vault RIM.
• Strong understanding of regulatory systems, data structures, and end-to-end regulatory change management processes across global domains.
• Experience with data visualization tools such as Tableau or Power BI.
• Strong analytical and problem-solving skills with high attention to detail and accuracy.
• Excellent communication and stakeholder management skills.
• Ability to work independently as well as collaboratively in a fast-paced, global environment.

Details

• Employment type: Permanent, full-time.
• Location: BTM Layout, Bengaluru, India.
• Work type: Office-based.