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