Regulatory Affairs Specialist | 薬事スペシャリスト

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Job details

Company overview

Our client is a globally recognized leader in advanced medical technology, specializing in orthopedics, sports medicine, and wound management. With a strong presence in Japan, they have established a dedicated branch that plays a crucial role in delivering innovative healthcare solutions to the local market. Supported by a vast network of over 17,500 employees and multiple branches worldwide, including a significant footprint in Asia, our client remains committed to improving patient outcomes through cutting-edge products and services. Their expertise and dedication make them a trusted partner in the healthcare industry, both in Japan and globally.

Responsibilities

There are currently three staff members in the team. One staff member will be on maternity/childcare leave, so we would like you to take charge of the regulatory affairs during that time. In order to quickly obtain regulatory approvals related to new businesses, you will obtain information appropriately and apply early or submit notifications at the appropriate time. Obtain information and apply early and submit notifications at the appropriate time. In order to comply with pharmaceutical regulations, take appropriate action in accordance with the content agreed upon by the team.For tasks other than applications, you will play an active and central role as a project leader or core member.
Main responsibilities:

• General duties (10%)
  • Make and implement improvement proposals for business operations. 
  • Provide support for various improvement proposals from other members. 
  • Properly maintain and manage internal documents, etc.
• Regulatory Affairs (90%)
  • Plan and implement appropriate strategies for approval applications, approval, and insurance coverage for approved items. 
  • Plan and implement strategies for applications, certification, and insurance coverage for certified items. 
  • Prepare and submit manufacturing and sales notifications at the appropriate time. 
  • Provide internal process support such as creating package inserts after approval/certification/notification until market launch. 
  • Consider and implement change management for existing products and pharmaceutical change procedures for approval/certification/notification forms. 
  • Review and edit advertisements and other external documents in accordance with pharmaceutical regulations. 
  • Communicate with overseas manufacturers and related internal departments for pharmaceutical application work. 

Requirements

Minimum requirements:

• Bachelor's degree in science, medicine or engineering or product knowledge/experience in the field of pharmaceutical affairs/wound care
• +3 years of experience in medical device regulatory affairs
• Consistently meets regulatory/quality requirements

Preferred qualifications:

• Experience working for a foreign company in the pharmaceutical, medical device, or similar industry
• Understands clinical requirements
• Good understanding of the Japanese medical system and industry
• Have a successful track record of quality/analysis or business process development
• Excellent explanation of product technology and methods
• Excellent written and verbal communication skills (TOEIC 700 or above or equivalent)
• Proficient in MS Office suite.
• Competencies (required behavioral characteristics)
• Excellent strategy execution and strategic thinking
• Highly effective interpersonal skills and ability to build relationships with internal/external stakeholders.
• Able to report appropriately on the progress of work
• Understanding high customer demands
• Highly effective personal time management
• Practical problem-solving skills
• Professionalism, integrity and honesty
• Excellent written and verbal communication skills
• Familiar with the latest techniques and knowledge in relevant organizations
• Familiar with compliance requirements

The appeal

【Location】

• Hybrid work system consisting of mostly remote and in-office work
• Depending on the job, you may need to commute to the head office.
• Remote work in distant locations is also possible

【Working Hours】

• Full flextime system (no core time)
• Standard monthly working hours: 160 hours

Salary

8 - 14 million yen

Location