Pharmasolution Hiring! Full Time Regulatory Affairs Executive in Federal Territory - Ricebowl

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 & Submissions

* 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.

* Operational Oversight

* Support pharmacovigilance activities including safety documentation and adverse event reporting.

* Assist in SOP development and revision to reflect current regulatory practices.

* Provide strategic input on regulatory pathways for unregistered oncology products under NPP

* Practical experience in pharmaceutical compounding and/or reconstitution of medicines, preferably within a hospital, pharmacy, clinical, or pharmaceutical environment.

* Basic knowledge and experience in Quality Assurance (QA) principles, including quality control procedures, documentation, SOP compliance, and good documentation practices.

* Familiarity with compounding procedures, aseptic techniques, preparation, handling, and storage of pharmaceutical products will be an advantage.