Senior Associate - Regulatory Affairs

Job Title: Associate/Senior Associate – Regulatory Affairs

Employment Type: Permanent, Full-time

Location: BTM Layout, Bengaluru, India

Work Type: Office-based

Experience: 3–5 years

About ClinChoice

ClinChoice is a partner to the largest pharmaceutical, medical device, and consumer care innovators in the world. Established in 1995, we provide expertise in clinical operations, biometrics, regulatory affairs, pharmacovigilance, medical affairs, and toxicology to help our partners advance healthcare by accelerating clinical trials with data-driven insights, delivering the best strategies for product registration, and enhancing patient safety through real-world and clinical analyses.

Our global delivery network has expanded to centers and satellite offices in the United States, Mexico, the United Kingdom, Armenia, China, Japan, India, and the Philippines to help our customers maintain regulatory compliance locally and globally.

We have forged future-defining partnerships with industry bodies and technology companies to develop cutting-edge solutions that deliver our expertise with quality and precision.

Key Responsibilities

• 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 both 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.

Skills & Qualifications

• 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.