Key Responsibilities
Regulatory Strategy & Compliance
Prepare and submit product registration dossiers (CTD/ACTD format) for pharmaceuticals and medical devices.
Manage lifecycle activities including renewals, variations, site transfers, and labeling updates.
Monitor regulatory changes (NPRA, MDA, ASEAN, ICH) and communicate updates to internal teams.
Documentation & Submission
Maintain regulatory trackers and databases (e.g., Product Master List, Variation Tracker).
Ensure timely submission of product licenses and renewals to avoid business disruption.
Review and approve product labeling, promotional materials, and artwork for compliance.
Stakeholder Engagement
Liaise with NPRA, MDA, and other regulatory bodies to facilitate evaluations and approvals.
Coordinate with internal departments (Sales, QA, R&D, Operations) to align regulatory strategies.
Respond to regulatory queries, deficiency letters, and post-market surveillance requests. <...