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RA/QA Pharmaceuticals Manager

Job Title: RA/QA Pharmaceuticals Manager
Contract Type: Permanent
Location: Minato-ku, Japan
Industry:
Salary: 9000000 - 11000000
Reference: 10754
Contact Name: Agnes Lewandowski
Job Published: November 02, 2018 09:00

Job Description

POSITION OVERVIEW:

 

Top German Pharmaceutical and Medical Device company with international presence is looking for their Regulatory Affairs and Quality Assurance Manager for their Pharmaceutical division.


1.) PRIMARY RESPONSIBILITIES:

 

Primary responsibilities entail: Health Authority and Global/Region RA correspondence for Pharmaceutical Regulatory Affairs Pharma Product, Business license, FMA registration, GMP application and inspection, Reimbursement application. Quality AssurancePharmaceutical QA officer for the entity

Maintains and improves local Quality Management System including local SOPs. QA Audit correspondenceProduct releaseSafety Pharma for Safety reporting document.

 

Health Authority inquiry and request:

  • Corresponding health authority inquiry and inspection to maintain current Pharma business
  • Corresponding health authority request concerning Pharma business

 

Global RA inquiry and request:

  • Corresponding Global RA inquiry concerning Pharma business
  • Explaining Japan registration situation to Global RA
  • Updating Pharma Database concerning Japan related products

 

Registration:

  • Product/FMAo Product information gathering from Global RA and manufacturing facilityo Acquisition of Marketing Approval and/or Accreditation (MA) for
  • PharmaceuticalsMaintenance of Marketing Approval for Pharmaceuticals o FMR and its maintenance
  • Business LicenseAcquisition of necessary business license for Pharma business
  • Maintenance of acquired business license for Pharma business

 

GMP application and inspection:

  • Information gathering for GMP inspection application from Global RA and manufacturing facility
  • Corresponding health authority GMP inspection to maintain current Pharma business and to acquire

 

Reimbursement application :

  • Information gathering for Reimbursement application for Pharma product
  • Compiling and Submitting an application file for Reimbursement
  • Corresponding health authority inquiry about the application contents

 

Regulatory administration:

  • Importing non-approved product sample for evaluation
  • Submitting an application file for reimbursement acquisition and maintenance
  • Scheduling and keeping timeline for both product registration and business license
  • Preparing and keeping budget for both product registration and business license
  • Reporting product registration status to related division

 

QMS:

  • Maintains and improves local Quality Management System including local SOPs.
  • Acts as a QM Contact in MU Japan and communicates with Regional/Global QM
  • Audit correspondence
  • CAPA management

 

Team building:

  • Supporting RA Director to build RA/QA/Safety organization
  • Supporting team members concerning both Pharma product and business license

 

 


2.) QUALIFICATIONS AND EXPERIENCE: (Academic, Professional, Relevant Job Knowledge)

 

Experience & Academics

  • New drug application for approval
  • Gap analyses of dossiers provided by overseas sites in comparison with Japanese regulations
  • Communication with HAs (negotiations/consultations/meetings)
  • GMP application for approval for new drug application/PCA/periodical GMP compliance application
  • New application/Renewal of FMA
  • Preparation of QA agreement under GQP ordinance
  • Manufacture site audit under GQP ordinance
  • Product license changes(labeling/other changes)and maintenance of approved products
  • Handling/creating of SOPs related to pharmaceutical quality system
  • Management of outsource companies
  • Proper Manufacturing Control and Quality Control of the approved products
  • Controlling Market Release of the approved products
  • Mutual collaboration among the internal departments or responsible persons concerned with the Quality Assurance Duties including the safety control management department
  • Handling the information on quality defects, etc.
  • Knowledge
    • GQP ordinance
    • GVP ordinance
    • ICH, Japanese regulatory requirements
  • Preferable
    • More than 5year experience of CMC/Regulatory CMC and more than 2-3year experience of QA for pharmaceuticals
    • Experiences with MD submission including STED preparation
    • Pharmacist

 

  • Organizational Knowledge
    • Understand the company systems and processes – QA, QC, Marketing, Sales, Customer service, IT, HR, GA, Finance, Manufacturing, Supply chain, Warehouse, Technical Service
    • Understand the global culture and different business manner

 

Personal Style

    • Be based on scientific evidence
    • Take careful consideration
    • Accepts reality
    • Self-starter

 

 

3.) SPECIAL SKILLS REQUIRED:

 

Behavioral Competencies

  • Cross-cultural communication skill
  • Team Building skill

 

Functional Competencies

  • Grasp overview of business project
  • Regulatory, quality and safety awareness
  • Business & market awareness