Introduction

What are you going to do

Our client is a global pharmaceutical company with a wide product portfolio

Develop and implement regulatory strategies for new and existing products in the assigned regions.
Provide guidance to the company regarding regulatory requirements and ensure compliance with all relevant regulations.
Submission and coordination with H.S.A. and with Regional RA APAC & RA HO
Collaborate with PIC for RA/QA of Business Partner/ Distributor in Hong Kong, Taiwan, and Brunei.
Coordinate and liaise with necessary requirements for BE Study, CDP, BE site inspection, BE specific study.
To facilitate critical submissions to H.S.A. as per commercial priority.
Prepare a regulatory plan for submissions and renewals and ensure implementation as per agreed timelines.
Provides up to date Registration status and estimated timeline for submission/ MA Approval.
Proactively provides input on the current and upcoming New Regulation/Guideline and assess possible impact to registered/ upcoming registration product.
Preparation of documentation for GMP accreditation and keep monitoring and record activities related to GMP.
Provides support for all Pharmacovigilance / Quality Complaint Report.
Recognize issues, roadblocks, and project risks, and proactively address these or raise to the attention of management with proposed solutions.
Provide Technical support for Tender participation, Hospital listing and Medical enquiries.

What you should do now

Apply to this job ad or send your CV across to me at e.ng@brunel.net for a confidential discussion.

(Brunel International South East Asia Pte Ltd, Registration Number: 199603098R | Company License Number : 16S8067 | Eve Ng EAP Registration Number R2198025.)

Essential skills and knowledge

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