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Open nowPosted today

Regulatory Affairs and Quality Assurance Manager

Ferring80 open roles

Where
Kwun Tong, Hong Kong
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Your applicationOpen nowRegulatory Affairs and Quality Assurance ManagerFerring · Kwun Tong, Hong Kong

  1. YouYes, apply to this one.

  2. CV RocketCV written for this posting.

  3. 25 readersRecruiter, hiring manager, skeptic. Round after round.

  4. CV RocketApplied on Ferring's own form.

The reply lands in your private mailbox

3×more interviews than doing it yourself with ChatGPT.

The clock on this job

Early applications get read.

13.9% of postings close within 7 days. Measured by our own scanner across the market. Ferring postings stay open a median of 13 days.

Share of postings closed within
  1. 2.2%1 day
  2. 4.7%3 days
  3. 13.9%7 days
  4. 22.4%14 days
  5. 38.1%30 days
  6. 59.0%60 days
This job: posted today

Ferring median: 13 days open

The posting

Job Description:

Your day at Ferring

Job Responsibilities:

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

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

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    The review screen in CV Rocket: how each CV was read, round by round.

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3×

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