Regulatory Affairs Manager (Pharma)

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

Responsibilities

• 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.
• 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.
• Provide up to date Registration status and estimated timeline for submission/ MA Approval.
• Proactively provide input on the current and upcoming New Regulation/Guideline and assess possible impact to registered/ upcoming registration product.
• Prepare documentation for GMP accreditation and monitor and record activities related to GMP.
• Provide 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.