Associate- Regulatory Affairs

Job Summary:

We are seeking a detail-oriented and analytically strong Veeva Vault RIM Specialist to support end-to end Regulatory Information Management (RIM) activities within a global regulatory environment. The role is responsible for managing regulatory data, change events, submissions, and lifecycle documentation within the Veeva Vault Regulatory platform. The ideal candidate will ensure data integrity, regulatory compliance, and timely execution of regulatory processes while supporting strategic and operational needs of regulatory teams across CMC, labelling, and country regulatory functions. 

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 lifecycle management of regulatory submissions and registrations across multiple regions.
• Track submission timelines, 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, Other Life Sciences disciplines.
• 0–3 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.