Associate Regulatory Affairs Specialist

Position : Associate Regulatory Affairs Specialist

Location : Mumbai, Maharashtra, India

Contract Position

Work Arrangement : Hybrid – On-site 2-3 days / week for training and collaboration Later REMOTE

Job Description :

We are seeking a detail-oriented and collaborative Regulatory Affairs Analyst to support global regulatory processes and compliance initiatives. This role will contribute to the automation and maintenance of regulatory documentation within a RIMS workflow solution, ensuring data integrity and timely reporting across multiple geographic regions. The ideal candidate will be based in Mumbai and work closely with cross-functional teams, with flexibility to support global operations across time zones.

Key Responsibilities

• Manage the global Registration, Notification, and Certification (RNC) process, including data entry, maintenance, and reporting in ETQ and other systems.
• Generate and analyze SAP reports to ensure regulatory compliance; identify new stop codes using Excel functions like VLOOKUP.
• Maintain and update master databases in Excel and Power BI; support monthly reporting and follow-ups with GRA teams.
• Validate and monitor data in EQT systems for accuracy and compliance.
• Collaborate with global teams to ensure timely regulatory submissions and documentation.
• Support audits and maintain documentation aligned with regulatory standards.
• Drive continuous improvement initiatives for data integrity and reporting processes.
• Provide functional expertise in regulatory documentation and RIMS workflows.
• Assist in maintaining standardized system approaches aligned with industry best practices.

Basic Qualifications

Preferred Qualifications

Additional Skills

Technical aptitude to assess needs, identify issues, recommend solutions, and lead change initiatives

Skills Required

Sap Erp, Power Bi, RIMS, Microsoft Excel