Regulatory Affairs Pharmacist

Regulatory Affairs & Quality Assurance Associate (Regulatory Pharmacist) is in charge of handling all transactions related to regulated drug products and medical devices. They will be the PDEA authorized pharmacist who is responsible in ensuring company compliance to rules and regulations. RA & QA Associate is also responsible for quality assurance process implementation of the company. As a regulatory affairs pharmacist, they will also have activities related to processing FDA applications such as registration renewals, post-approval applications, or assistance to dossier review for initial product applications.

DUTIES AND RESPONSIBILITIES

Maintains validity of FDA Licenses, Product Registrations and Certifications

Ensures company compliance to FDA regulations

Liaises with government offices such as FDA for the submission of applications

Handles and prepares regulatory documents to secure approval within the set timelines

Provides support to internal customers in providing regulatory documents for product inclusion

Support in departmental assigned task such as product quality checking, handling product complaint and pharmacovigilance practices, etc.

Summary of role requirements:

Looking for candidates available to work:

Monday: Morning, Afternoon

Tuesday: Morning, Afternoon

Wednesday: Morning, Afternoon

Thursday: Morning, Afternoon

Friday: Morning, Afternoon

2-3 years of relevant work experience required for this role

Working rights required for this role

Full time