Business Development Coordinator

Role Overview

We are looking for a meticulous Regulatory Affairs (RA) & Business Development (BD) Coordinator to join the Managing Director's Office. This role is pivotal in managing regulatory affairs and facilitating cross-departmental collaboration, covering dossier tracking, regulatory Management Information Systems (MIS), and monitoring action items across multiple teams including RA, Research & Development (R&D), BD, Quality Assurance (QA), Finance, and Legal.

The coordinator will also work alongside senior leadership on business expansion efforts and strategic projects, while providing documentation and reporting support to the MD's Office and key executives.

Key Responsibilities

• Facilitate coordination among RA, R&D, BD, QA, and other departments to oversee regulatory documentation processes from initiation to final approval.
• Manage registrations, renewals, variations, amendments, and dossier updates for products across different markets, maintaining comprehensive trackers categorized by country, product, and customer.
• Maintain and monitor the Dossier Request Form (DRF) Tracker, comparing planned and actual timelines, following up on delays, and escalating issues to management as needed.
• Generate monthly regulatory MIS reports and dashboards; support reporting for management meetings including S&OP and BD reviews.
• Document Minutes of Meetings (MoMs) for regulatory and BD coordination sessions, keep a centralized Action Tracker, and ensure timely completion of critical or overdue tasks by following up with responsible parties.
• Implement business growth, research, and strategic initiatives assigned by senior management or the MD’s Office; project specifics will be defined on a case-by-case basis beyond core RA and BD duties.
• Maintain detailed documentation and record communications, decisions, and instructions issued by the MD's Office, management, and leadership.
• Prepare and archive MoMs from senior management meetings and track resulting action items until their resolution.