CLINCHOICE is hiring for the position of Associate – Regulatory Affairs in Bengaluru, Karnataka, India. The role focuses on Regulatory Information Management (RIM), regulatory change management, submission lifecycle management, and regulatory data quality using the Veeva Vault RIM platform.
This opportunity is suitable for pharmacy and life sciences graduates with 0–3 years of relevant experience who have an understanding of regulatory processes and strong analytical skills.
Job Details
| Particulars | Details |
|---|---|
| Company | CLINCHOICE |
| Job Title | Associate – Regulatory Affairs |
| Job Location | Bengaluru, Karnataka, India |
| Experience | 0–3 years |
| Department | Regulatory Affairs |
| Specialization | Regulatory Information Management (RIM) |
| Platform | Veeva Vault RIM |
| Eligible Qualifications | B.Pharm, M.Pharm, Pharm.D, B.Sc. or M.Sc. in Life Sciences, Biotechnology, Biochemistry, and other Life Sciences disciplines |
Position Overview
The Associate – Regulatory Affairs will support end-to-end regulatory information management activities in a global regulatory environment. The role involves maintaining regulatory records, assessing regulatory changes, managing submission-related documentation, monitoring timelines, and ensuring the accuracy and completeness of regulatory data.
The selected candidate will collaborate with CMC Product Strategists, Labelling Leads, Country Regulatory Strategists, and other cross-functional stakeholders.
Key Responsibilities
- Review and manage regulatory events and changes initiated in Veeva Vault RIM.
- Conduct system impact assessments for regulatory changes and document the outcomes accurately.
- Create and maintain regulatory activities, objectives, submissions, global content plans, and associated records.
- Ensure accurate linkage and completeness of event details, change items, and label concepts.
- Support CMC Product Strategists, Labelling Leads, and Country Regulatory Strategists.
- Assist with the lifecycle management of regulatory submissions and registrations across multiple regions.
- Track submission timelines, regulatory milestones, and global submission schedules.
- Monitor regulatory workflows, submission tracking, and health authority interactions.
- Perform regulatory data entry, validation, reconciliation, and quality control checks.
- Collaborate with stakeholders to define data requirements aligned with business processes and regulatory needs.
- Analyse regulatory datasets to identify trends, inconsistencies, and operational gaps.
Eligibility and Qualifications
Candidates must have a bachelor’s or master’s degree in one of the following disciplines:
- B.Pharm – Bachelor of Pharmacy
- M.Pharm – Master of Pharmacy
- Pharm.D – Doctor of Pharmacy
- B.Sc. or M.Sc. in Life Sciences
- Biotechnology
- Biochemistry
- Other Life Sciences disciplines
Applicants should have 0–3 years of relevant experience in Regulatory Information Management, preferably with hands-on exposure to Veeva Vault RIM.
Required Skills
- Understanding of regulatory systems and data structures.
- Knowledge of end-to-end regulatory change management processes across global domains.
- Experience with Tableau or Power BI for data visualization.
- Strong analytical and problem-solving abilities.
- High attention to detail and data accuracy.
- Effective communication and stakeholder management skills.
- Ability to work independently and collaboratively in a global, fast-paced environment.
