Job Title: Regulatory Affairs Associate – Regulatory Information Management (RIM)

5 - 7 Years
1 Opening
Bangalore, Hyderabad

Job Title: Regulatory Affairs Associate – Regulatory Information Management (RIM) - UST Band B1

Role detailed classification

RIM (Regulatory Information Management)

Job Summary: We are seeking highly skilled and experienced Life Sciences (LS) Regulatory Affairs (RA) Associate – RIM to join our LS Practice team. The successful candidate will be responsible for LS Regulatory Information Management (RIM) and/or other assigned RA activities. The role will involve knowledge of Global Regulatory Affairs guidelines, platforms and systems to undertake various assigned roles and responsibilities, included but not limited to below described activities.

Key Responsibilities:

Life Sciences Regulatory Affairs Associate - RIM plays a crucial role in ensuring compliance within the pharmaceutical, medical devices and biotechnology industries by managing the assigned regulatory affairs RIM activities for regulatory submissions, health authority queries, approvals, variations, renewals/ licence maintenance & regulatory compliance throughout the product lifecycle. This role involves preparing and reviewing regulatory information, maintaining compliance with global standards and regulations, and utilizing Regulatory systems to track and organize critical data for various assigned activities.

Specific RIM activities

1. Regulatory Information Management (RIM): Utilizing the assigned RIM system(s) to manage and maintain regulatory information, track submissions, health authority correspondence, and approvals across regions and functions. Support data migration, configuration, validation, and user acceptance testing (UAT).

2. Maintain and update regulatory data in RIM systems (e.g., Veeva Vault, ArisGlobal, EXTEDO etc.) to ensure accuracy, completeness, and compliance

3. Support regulatory submissions by coordinating data entry, document tracking, and metadata management

4. Collaborate with cross-functional teams (Regulatory Affairs, CMC, Clinical, Safety) to gather and validate submission-related information

5. Monitor regulatory changes and ensure timely updates to product registration and lifecycle data

6. Generate reports and dashboards for regulatory compliance, submission tracking, and data quality metrics

7. Assist in audits and inspections by ensuring traceability and readiness of regulatory records

8. Participate in system upgrades and validation activities, including testing and documentation

General responsibilities

9. Compliance and Standards: Ensuring adherence to global regulatory guidelines such as ICH, ICH-GCP, GMP and managing product registration and maintenance across different markets.

10. Cross-functional Collaboration: Working with various client teams (e.g., RA, QA etc.) to ensure timely and accurate regulatory information and ongoing compliance. Monitor regulatory changes and ensure RIM system compliance. Support audits and inspections by Notified Bodies and regulatory agencies by maintaining accurate records and submission history.

11. Data Management and Reporting: Maintaining accurate records of all regulatory activities and leveraging Document Management, Publishing and RIM tools to extract insights and support decision-making.

Qualifications & experience:

• Graduate/ Postgraduate degree in Pharmacy/ Life Sciences, or a related field.
• 4-6 years in LS RA-RIM
• Knowledge of and Proficiency in Regulatory RIM e-Systems e.g. Veeva Vault-RIM is mandatory.
• Good to have knowledge of eCTD, Lorenz, GlobalSubmit etc. Proven experience in requirement gathering, documentation, and stakeholder management, Familiarity with eCTD, IDMP, XEVMPD , and GxP compliance, Experience with CSV/validation support is a plus.
• Basic knowledge of industry standards and regulations related to Quality Management Systems (e.g., ISO 9001, ISO 13485, FDA & Global Health authority regulations).
• Experience with other regulatory systems (e.g., ArisGlobal, Lorenz, MasterControl) and knowledge of Veeva Vault Quality is an added advantage.
• Excellent communication, collaboration, presentation and stakeholder management skills.
• Strong analytical, attention to detail and problem-solving abilities.
• Stable track record in LS Regulatory RIM domain in a Mid-large Organisation.
• Proficiency in MS Office, Regulatory work processes and good knowledge of Global Regulatory submission requirements especially USFDA, MHRA, EMA, APAC, GCC, LatAm for Medical Devices and/or Medicinal/ Biotech products.

Regulatory Affairs, RIM systems,UAT, Data Management, Metadata,Testing and Documentations