Associate Regulatory Specialist

Associate Regulatory Specialist Substance and Material CoE

Location: Pune, India (GBS+) | Function: Global Regulatory Affairs – Substance and Material CoE Role Purpose

Execute standardized substance and raw material regulatory activities that have been approved for globalization to the SSC. The role supports compliant, timely RM processes through documentation handling, SAP transactions, reporting, and task delivery under regional and global direction.

The role increases scale, data quality, and process efficiency while enabling the SMEs and Regional Leads to focus on strategic and authority-facing work.

Key Responsibilities

• Execute standardized substance and raw material regulatory tasks using approved SOPs, RIM workflows, and regional or global guidance.
• Maintain, validate, and update regulatory data, documentation, trackers, records, and system transactions in SAP, or other internal database or platform.
• Support compliance confirmations, regulatory surveys, impact analysis inputs, standard reports, RegHits, and audit-ready documentation.
• Escalate non-standard activities, interpretation needs, exceptions, or judgement-based decisions to regional SMEs.
• Complete assigned tasks for global and cross-regional initiatives focused on standardization, data quality, process efficiency, and scalable execution.

Qualifications

• Bachelor’s degree in Chemistry, Chemical Engineering or related field
• 1–5 years of regulatory operations or substance compliance experience
• Strong data, process, documentation, SAP, Excel, and Microsoft Office skills
• Experience in global or SSC environments preferred