ASSOCIATE MANAGER

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Date: Mar 18, 2026

Location: Bangalore, KA, IN

Company: bioconbiolP2

Company Overview

Role Purpose

The Team Lead – GRA – Lifecycle Management oversees and leads a team responsible for managing all post-approval regulatory activities related to pharmaceutical products. This includes regulatory variations, renewals, labeling updates, and compliance commitments across global markets. The role ensures that lifecycle submissions are executed accurately, on time, and in alignment with global regulatory strategies and local health authority requirements, supporting uninterrupted product availability and compliance.

Academic Stream

0

Work experience (in months)

0

Job Responsibility and key Decisions

Lead the team in planning, preparing, and submitting all postapproval regulatory documents globally.

Develop and execute regulatory strategies for lifecycle activities ensuring compliance with timelines and health authority expectations.

Collaborate with crossfunctional teams to assess the impact of changes and define regulatory pathways.

Monitor submission status and manage responses to health authority queries or deficiencies.

Maintain accurate records and tracking of all lifecycle submissions.

Ensure processes and documentation comply with global regulatory standards and audit requirements.

Coach and develop team members to enhance regulatory knowledge and performance.

Drive continuous improvement initiatives in lifecycle management processes.

Report key metrics, risks, and progress to senior management.

Key Decisions

Prioritization of lifecycle submissions and allocation of team resources.

Regulatory approach selection for postapproval changes.

Escalation and resolution of regulatory compliance issues.

Approval of submission content and regulatory strategies.

Decisions related to team training and performance management.