Associate- Regulatory Affairs

ClinChoice; Bengaluru; On-site; INR 600,000 - 1,200,000; Full time

Job summary

ClinChoice in Bengaluru seeks a detail-oriented Veeva Vault RIM Specialist to manage regulatory data, changes, and lifecycle documentation within the Veeva Vault Regulatory platform.

The role supports CMC, labeling, and country regulatory functions, ensuring data integrity, regulatory compliance, and timely submissions in a global context.

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 related Life Sciences field.
• 0–3 years of relevant RIM experience, preferably with hands-on exposure to Veeva Vault RIM.
• Strong understanding of regulatory systems, data structures, and end-to-end regulatory change management across global domains.
• Experience with data visualization tools such as Tableau or Power BI.
• Excellent analytical, problem-solving, and attention to detail.

Responsibilities

• Review and manage regulatory events (changes) in Veeva Vault RIM.
• Perform system impact assessments and document outcomes.
• Create and maintain Regulatory Activities, Objectives, Submissions, and Global Content Plans.
• Ensure linkage and completeness of Event Details, Change Items, and Label Concepts.
• Support Regulatory Strategists and lifecycle management of submissions across regions.
• Track submission timelines and global regulatory milestones.

Skills

RIM basics

Veeva Vault RIM

Data visualization

Analytical skills

Stakeholder management

Communication

Independent & collaborative

Education

B.Pharm

M.Pharm

Pharm.D

BSc Life Sciences

MSc Life Sciences

Biotechnology

Biochemistry

Tools

Tableau

Power BI

Veeva Vault RIM

Job description

Job Description:

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.

Requirements: