ClinChoice is hiring for the position of Associate/Senior Associate – Regulatory Affairs at its BTM Layout location in Bengaluru, India. This is a permanent, full-time, office-based opportunity for candidates with 3–5 years of relevant experience in Regulatory Information Management (RIM).
Candidates with experience in Veeva Vault RIM, regulatory change management, submission lifecycle management, and regulatory data management can apply for this opportunity.
Job Details
| Particulars | Details |
|---|---|
| Company | ClinChoice |
| Job Role | Associate/Senior Associate – Regulatory Affairs |
| Job Location | BTM Layout, Bengaluru, India |
| Employment Type | Permanent, Full-Time |
| Work Mode | Office-Based |
| Experience | 3–5 Years |
| Job Function | Regulatory Affairs |
| Key System | Veeva Vault RIM |
Positions Available
Associate / Senior Associate – Regulatory Affairs
The selected candidates will support global regulatory operations, manage regulatory events and changes within Veeva Vault RIM, maintain regulatory records, and assist with submission lifecycle management across multiple regions.
Key Responsibilities
- Review and manage regulatory events and changes initiated within the Veeva Vault RIM system.
- Perform system impact assessments for regulatory changes and document assessment outcomes.
- Create and maintain Regulatory Activities, Regulatory Objectives, Submissions, and Global Content Plans.
- Ensure completeness and appropriate linkage of Event Details, Change Items, and Label Concepts.
- Provide strategic and operational regulatory support to CMC Product Strategists, Labelling Leads, and Country Regulatory Strategists.
- Support lifecycle management of regulatory submissions and registrations across multiple regions.
- Track submission timelines and regulatory milestones.
- Monitor regulatory workflows, submission tracking, and health authority interactions.
- Manage and maintain regulatory data within Veeva Vault RIM.
- Perform data entry, validation, reconciliation, and quality control checks.
- Collaborate with cross-functional stakeholders to define regulatory data requirements.
- Analyse regulatory datasets to identify trends, inconsistencies, and operational gaps.
Eligibility and Qualifications
Candidates should possess one of the following educational qualifications:
- B.Pharm
- M.Pharm
- Pharm.D
- B.Sc. Life Sciences
- M.Sc. Life Sciences
- Biotechnology
- Biochemistry
- Other Life Sciences disciplines
Experience Requirements:
- 3–5 years of relevant experience in Regulatory Information Management (RIM).
- Hands-on experience with Veeva Vault RIM is preferred.
Required Technical Skills
- Veeva Vault RIM: Experience managing regulatory information and regulatory events.
- Regulatory Change Management: Understanding of end-to-end regulatory change management processes.
- Regulatory Submissions: Knowledge of submission lifecycle management and regulatory milestones.
- Regulatory Data Management: Experience with data entry, validation, reconciliation, and quality control.
- Data Visualization: Experience with Tableau or Power BI.
- Regulatory Systems: Strong understanding of regulatory systems and data structures.
- Analytical Skills: Ability to identify data inconsistencies, trends, and operational gaps.
- Stakeholder Management: Effective communication and cross-functional collaboration.
About ClinChoice
Established in 1995, ClinChoice provides services to pharmaceutical, medical device, and consumer care companies across multiple areas of healthcare research and development.
Its areas of expertise include:
- Clinical Operations
- Biometrics
- Regulatory Affairs
- Pharmacovigilance
- Medical Affairs
- Toxicology
ClinChoice operates through a global delivery network with centers and satellite offices in the United States, Mexico, the United Kingdom, Armenia, China, Japan, India, and the Philippines.
