Regulatory Affairs and Quality Assurance Manager

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

Regulatory Affairs:

1) Responsible of new product registration and new site registration.

2) Product life cycle management and maintenance of product license and GMP certificate

3) Provide regular regulatory updates to country GM and Regional RA Head

4) Support M&S in regulatory arena

5) Timely update and perform verification of RIMS records

Local Safety Officer:

1) Processing and reporting to GPV and Health Authorities all safety information received from market, post-authorisation studies, scientific literature and Health Authorities.

2) Keep a system to gather the above information. Prepare and update local Pharmacovigilance.  SOPs according to GPV procedures and policies.

3) Training of all the employees with regard to safety reporting.

Local Complaint Officer:

1) Act as the responsible person for handling product complaints and recall according to national legislation and internal SOPs.

2)  Report product complaint to QA-track

Quality Assurance:

1) QRB report

2)TFDA GDP inspection

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

4) DRP for SOP management

QP for Product Release:

1) Handling of product release to ensure product on market in compliance with TFDA approval

2) Management of temperature deviation and report QA-track

• 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.