DEPUTY MANAGER

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Date: Mar 17, 2026

Location: Bangalore, KA, IN

Company: bioconbiolP2

Company Overview

Role Purpose

The Team Lead – GRA – Emerging Markets is responsible for leading regulatory submission planning, execution, and lifecycle management for pharmaceutical products across emerging market regions, including Asia (ex-Japan), Africa, Middle East, CIS, Latin America, and Eastern Europe. The role involves managing regulatory activities for both new product registrations and post-approval changes, ensuring full compliance with local health authority requirements and alignment with global regulatory strategies. The Team Lead supports cross-functional collaboration and acts as the primary regulatory point of contact for assigned countries or product portfolios in emerging markets.

Academic Stream

0

Work experience (in months)

0

Job Responsibility and key Decisions

Lead the preparation, review, and coordination of regulatory submissions new registrations and lifecycle activities across emerging markets.

Ensure regulatory filings comply with both global requirements and local country regulations.

Collaborate with global regulatory leads, country affiliates, and external consultants to ensure accurate and timely submissions.

Monitor and interpret evolving regulations in emerging markets and communicate implications to internal stakeholders.

Review and validate regulatory documents such as Product Information, local labeling, administrative forms, and qualityCMC modules.

Act as the regulatory liaison with local affiliates or incountry regulatory partners for ongoing submission support and query resolution.

Maintain submission tracking, metrics, and documentation in internal RIM or project systems.

Support auditinspection readiness and ensure adherence to regulatory SOPs and documentation standards.

Train and mentor junior regulatory staff involved in emerging market submissions.

Key Decisions

Determination of submission strategies, timelines, and documentation requirements for specific emerging market countries.

Escalation of risks related to regulatory compliance, submission delays, or HA queries.

Prioritization of work based on business impact, product launch plans, and marketspecific requirements.

Recommendations on resource planning and process optimization for regional submissions.