Quality Assurance & Regulatory Affairs Manager – Japan

Position Overview 

Reporting to Japan Country Lead & Head of Complinance & PV Manager, as the Quality Assurance and Regulatory Assurance Manager, the person is responsible for supervising quality management operations and maintains the system to ensure that it is carried out properly and smoothly. In addition, ensures submission of regulatory application documents of products & obtaining approvals.

Key Responsibilities 

 Hinseki/Qsuality Assurance Manager should:

1. Supervise quality management operations and maintains the system to ensure that it is carried out properly and smoothly.

2. Where necessary, written communication or instructions are given to Manufacturers, etc., Marketing Authorisation Holders, Pharmacy Establishments, Hospital and Clinic Establishments and other relevant persons.

3. Decide the market release of the products.

4. Periodically check whether manufacturers etc. are carrying out proper manufacturing and quality control in accordance with the arrangements and prepare records.

5. Instruct manufacturers, etc. to take improvement measures in manufacturing and quality control as necessary, and evaluate and confirm the results.

6. Instruct manufacturers, etc. to take necessary measures, such as improvements, for changes that may have a significant impact on quality.

7. Evaluate quality information and take remedial action based on the evaluation or investigation of causes.

8. Take necessary measures, including product recalls, when quality defects or the risk of such defects are identified.

9. Ensure close cooperation with the Safety Management Control Division and other relevant divisions to ensure the smooth implementation of such measures.

10. Conduct periodic self-inspections of quality control operations.

11. Take necessary improvement measures based on the results of the self-inspection.

12. Provide education and training for persons engaged in quality control operations.

13. Report to Sokatsu as necessary in the above operations.

14. Work closely with the global QA department.

Regulatort Assurance Manager

1. Submission of regulatory application documents of products & obtaining approvals
   1. Writes, obtains, and maintains approvals for the Japanese market and plan the strategy.
   2. Plans submission schedule and monitor the status.

• Prepares import/reimbursement application documents and maintains the approvals.

1. Collects information of new product under development.

2. Change control of already-approved products including regulatory submissions

   1. Collects and assesses product change information to take necessary actions.
   2. Submits and obtains approvals of product variations to ensure up to date product compliance

3. RA Document control  & regulatory intelligence

   • Collects updated PMD Act related notices and takes necessary actions including interpretation in the context of iNova’s business and products, and implements risk mitigation strategies.
   • Collects information directly from the industry to secure company’s benefits.

4. Education and training for developing skills

Other projects

Other global, local and ad-hocl projects related to regulatory affairs & medical affairs may be assigned based on the skill & experience

Qualifications 

• Bachelor’s Degree required.

• Pharmacist Liscence (welcome but not required)

• 10- 15 years solid regulatory affairs background in the pharmaceutical industry

Skills & Experience

• Deep understanding of relevant regulatory requirements for medicines, devices, complementary medicines, dietary supplements, cosmetics and foods (Desirable)

• Familiar with fundamental principles of clinical, regulatory, registration and compliance issues in the regions and how those regulations impact on the development, introduction, manufacture, quality, registration and marketing of iNova’s products

• Strong project planning and organisational skills and a high degree of multi-project tasking; ability to handle multiple projects within an active and wide range of health care products

• Understanding of matrix organisational issue and ability to communicate to multiple stakeholders to facilitate achievement of key strategic objectives

• Demonstrated strong interpersonal, communication and influencing skills

• Demonstrated leadership skills; proven decision-maker, hands-on and action-oriented style

• Native level Japanese language and business level English required.

Soft Skill

• Ability to work effectively within a team in a fast-paced environment

• Establish good working relationship with both internal and external parties

• Demonstrate ability to handle multiple projects

• Strong organizational, planning and follow-up skills

• Good IT skill is an added advantage but not mandatory (Proficient in Microsoft Office)

• High level of attention to details and accuracy

• Strong communication skills (both oral and written) and time-management skills

• Able to interact with internal and external stakeholders in a professional manner

• Self-motivated, able to prioritize, multi-task and meets deadline in a timely manner

• Positive, proactive attitude and a keen learner

• Proven track record of developing people with specific focus on ambition and passion

• High capability in delivering results among strategy changes and transformations

• Decisive, self-motivated

Additional Requirments 

Adhere to company values at all times