REGULATORY AFFAIRS EXECUTIVE

What You'll Be Doing
-Prepare and submit regulatory dossiers to the National Pharmaceutical Regulatory Agency (NPRA).
-Manage product registrations, variations, renewals, and regulatory maintenance.
-Ensure compliance with Good Distribution Practice (GDP) guidelines.
-Oversee pharmacovigilance activities including adverse event reporting.
-Maintain regulatory documentation and product licenses.
-Support audits, regulatory inspections, and quality compliance.
-Conduct product training and provide regulatory guidance to internal teams.

What We're Looking For
-Bachelor’s Degree in Pharmacy.
-Registered Pharmacist with the Pharmacy Board of Malaysia.
-3–4 years of Regulatory Affairs experience in the Malaysian pharmaceutical industry.
-Strong knowledge of Malaysian pharmaceutical regulations and NPRA submissions.
-Familiarity with pharmacovigilance and GDP compliance.
-Organized, detail-oriented, and able to manage regulatory timelines.