SENIOR EXECUTIVE

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Date: Mar 4, 2026

Location: Bangalore, KA, IN

Company: bioconbiolP2

Company Overview

Role Purpose

The Team Member – GRA – Emerging Markets is responsible for supporting regulatory activities related to the registration and lifecycle management of pharmaceutical products in emerging markets, including regions such as Asia-Pacific (excluding Japan), Latin America, Africa, Middle East, CIS, and Eastern Europe. The role involves assisting in the preparation and submission of regulatory dossiers, managing documentation, and ensuring compliance with local regulatory requirements to support timely product approvals and post-approval changes.

Academic Stream

0

Work experience (in months)

0

Job Responsibility and key Decisions

Support the preparation, review, and submission of registration dossiers and lifecycle management filings for emerging market countries.

Collaborate with global and local regulatory teams to gather, compile, and format documentation as per countryspecific requirements.

Track submission timelines, approvals, and health authority queries, ensuring timely updates in internal systems.

Assist in managing countryspecific labeling requirements, renewals, and variations.

Maintain proper documentation and ensure inspectionaudit readiness of regulatory files.

Support query responses from health authorities in collaboration with senior regulatory personnel or affiliates.

Monitor changes in regulatory requirements through internal resources and update templates or checklists accordingly.

Key Decisions

Identify missing or outdated documents in regulatory dossiers and notify the responsible stakeholders.

Suggest improvements to submission tracking or document filing processes.

Prioritize assigned tasks to meet submission and approval deadlines, with guidance from team leads.