Regulatory Affairs and Quality Assurance Manager

Location: Kwun Tong, Hong Kong

Your day at Ferring

Job Responsibilities

Regulatory Affairs, Local Safety Officer, Local Complaint Officer, Quality Assurance, QP for product release, DRP

Regulatory Affairs

• Responsible of new product registration and new site registration.
• Product life cycle management and maintenance of product license and GMP certificate
• Provide regular regulatory updates to country GM and Regional RA Head
• Support M&S in regulatory arena
• Timely update and perform verification of RIMS records

Local Safety Officer

• Processing and reporting to GPV and Health Authorities all safety information received from market, post-authorisation studies, scientific literature and Health Authorities.
• Keep a system to gather the above information. Prepare and update local Pharmacovigilance. SOPs according to GPV procedures and policies.
• Training of all the employees with regard to safety reporting.

Local Complaint Officer

• Act as the responsible person for handling product complaints and recall according to national legislation and internal SOPs.
• Report product complaint to QA-track

Quality Assurance

• QRB report

2)TFDA GDP inspection

3)Support Third-Party selection, vendor assessment and technical agreement

• DRP for SOP management

QP for Product Release

• Handling of product release to ensure product on market in compliance with TFDA approval
• Management of temperature deviation and report QA-track

Behind our Talents, there is YOU

Job Requirements：

• Bachelor’s degree in bioscience
• 3+ years of RA experience in an MNC pharmaceutical company
• NCE NDA/BLA experience is a plus.
• People management experience is a plus.

Location

Ferring Hong Kong