Lead I - Business Analysis

5 - 7 years

5 Lacs

Posted:22 hours ago| Platform: Naukri logo

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Job Type

Full Time

Job Description

Job Title:

RIM (Regulatory Information Management)

Job Summary:

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

Regulatory Information Management (RIM):

Maintain and update regulatory data

Support regulatory submissions

Collaborate with cross-functional teams

Monitor regulatory changes

Generate reports and dashboards

Assist in audits and inspections

Participate in system upgrades and validation activities

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.

Required Skills

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

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