Regulatory & Quality Director, JP and KR

Job Title: Regulatory & Quality Director, JP and KR

Location: Tokyo, Japan

Overview

We are seeking an experienced Regulatory & Quality Director to join a prominent organization in Tokyo. This role is critical for overseeing regulatory compliance and quality assurance across Japan and Korea. The ideal candidate will have a strong background in regulatory affairs, quality management systems, and a passion for ensuring product safety and efficacy.

Key Responsibilities

• Regulatory Compliance:
  Lead the regulatory strategy for Japan and Korea, ensuring compliance with local regulations and industry standards for product registration and maintenance.

• Quality Management:
  Oversee the development, implementation, and continuous improvement of quality management systems to ensure product quality and safety.

• Cross-Functional Collaboration:
  Work closely with R&D, manufacturing, and marketing teams to align regulatory and quality strategies with business objectives.

• Risk Management:
  Identify and mitigate regulatory and quality risks, developing action plans to address potential issues proactively.

• Training and Development:
  Provide training and guidance to internal teams on regulatory requirements and quality standards, fostering a culture of compliance and excellence.

• Stakeholder Engagement:
  Maintain strong relationships with regulatory authorities and industry associations, representing the organization in meetings and discussions.

• Performance Monitoring:
  Track and analyze key performance indicators related to regulatory and quality initiatives, preparing regular reports for senior management.

Qualifications

• Education:
  Bachelor’s degree in Life Sciences, Pharmacy, Engineering, or a related field; a master’s degree is preferred.

• Experience:
  10+ years of experience in regulatory affairs and quality management, with a focus on the pharmaceutical or healthcare industries.

• Leadership Skills:
  Proven ability to lead and develop teams, with strong project management skills and a collaborative approach.

• Analytical Skills:
  Excellent analytical and problem-solving abilities, with a thorough understanding of regulatory requirements in Japan and Korea.

• Communication Skills:
  Strong verbal and written communication skills in English and Japanese/Korean, with the ability to effectively engage diverse stakeholders.

• Detail-Oriented:
  A meticulous approach to regulatory and quality documentation and processes.

Why Join This Organization?

This is an exceptional opportunity to lead regulatory and quality initiatives in a dynamic and innovative environment. If you are a dedicated professional with a passion for compliance and quality assurance, we invite you to apply and contribute to a team committed to excellence and safety in products!