ASSOCIATE MANAGER

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Date: Feb 27, 2026

Location: Bangalore, KA, IN

Company: bioconbiolP2

Company Overview

Role Purpose

The Team Lead – GRA – Advanced Markets is responsible for leading the execution of regulatory strategies and managing regulatory submissions for pharmaceutical products in highly regulated markets such as the United States (FDA), European Union (EMA), Japan (PMDA), Health Canada, and Australia (TGA). The role involves ensuring timely and compliant submissions for both new product approvals and post-approval changes, in alignment with global regulatory plans and local market requirements. The Team Lead serves as a subject matter expert for advanced market regulations and supports regulatory interactions with health authorities.

Academic Stream

LIFE SCIENCES

Work experience (in months)

0

Job Responsibility and key Decisions

Lead regulatory submission planning and execution for advanced market regions, ensuring ontime delivery and full compliance.

Prepare, review, and compile regulatory submissions including INDs, NDAs, MAAs, BLAs, and associated lifecycle management filings.

Coordinate with global and regional stakeholders to align on submission strategies and ensure crossfunctional readiness.

Monitor and interpret regulatory requirements in advanced markets, advising internal stakeholders on implications and actions.

Support and guide interactions with health authorities, including meetings, briefing books, and response strategies.

Train and mentor junior team members or regulatory associates on best practices and regulatory expectations.

Maintain accurate and uptodate tracking of submission timelines, status, and approvals using internal systems.

Contribute to inspection readiness and ensure all documentation and processes are auditcompliant.

Support global regulatory projects, due diligence, or labeling initiatives as needed.

Key Decisions

Submission timelines, sequencing, and resource planning for assigned markets or products.

Regulatory approaches for postapproval changes or new filings in accordance with local and global requirements.

Escalation of risks and challenges related to submission readiness or regulatory compliance.

Recommendations on responses to health authority questions or deficiencies.

Contribution to internal SOPs and process improvements for regulatory operations.