Senior Associate - Regulatory Affairs New Bengaluru, India

ClinChoice; Bengaluru; On-site; INR 900,000 - 1,400,000; Full time

Job summary

ClinChoice is seeking a Regulatory Information Management specialist to manage regulatory events in Veeva Vault RIM and support global submissions. The role requires 3–5 years of RIM experience and a Life Sciences degree.

Proficiency in Tableau or Power BI and strong analytical skills are essential for success in a fast-paced, global environment. Ideal candidates will collaborate with cross-functional teams, ensure data accuracy, and drive regulatory milestones across multiple regions.

Qualifications

• Bachelor’s or master’s degree in life sciences or Pharm programs.
• 3-5 years of RIM experience, preferably with Veeva Vault RIM.
• Experience with data visualization tools (Tableau or Power BI).
• Strong analytical, problem-solving, and attention to detail.

Responsibilities

• Review and manage regulatory events in the Veeva Vault RIM system.
• Perform system impact assessments for regulatory changes.
• Create and maintain regulatory activities, objectives, submissions, global content plans, and records.
• Track submission timelines and regulatory milestones across regions.
• Collaborate with cross-functional stakeholders to gather data requirements.

Skills

Analytical thinking

Communication skills

Stakeholder management

Attention to detail

Education

Bachelors/Masters in Life Sciences or Pharm

Tools

Veeva Vault RIM

Tableau

Power BI

Job description

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.