Job Title: Regulatory Affairs Specialist
Location: Tokyo, Japan
Job Type: Full-time (permanent)
Our client, a leading pharmaceutical company dedicated to improving global health through innovative medicines. They are committed to excellence in research, development, and regulatory compliance.
Job Summary: The Regulatory Affairs Specialist will be responsible for ensuring that the products comply with all regulations and standards set by the Japanese regulatory authorities. This role involves preparing and submitting regulatory documents, maintaining product licenses, and collaborating with cross-functional teams to achieve regulatory compliance.
Key Responsibilities:
- Prepare and submit regulatory documents for product registration, amendments, and renewals to the Pharmaceuticals and Medical Devices Agency (PMDA).
- Maintain and secure product licenses, ensuring compliance with local regulations, company policies, and global standards.
- Monitor and interpret regulatory requirements and guidelines, providing strategic advice to internal teams.
- Collaborate with R&D, Quality Assurance, and Marketing teams to ensure regulatory requirements are met throughout the product lifecycle.
- Manage regulatory submissions, including Clinical Trial Applications (CTAs), New Drug Applications (NDAs), and post-marketing surveillance reports.
- Liaise with regulatory authorities and represent the company in regulatory meetings and inspections.
- Ensure timely reporting of adverse events and product complaints in accordance with regulatory requirements.
- Maintain up-to-date knowledge of regulatory changes and industry trends.
Qualifications:
- Bachelor's degree in Pharmacy, Life Sciences, or a related field.
- Minimum of 3-5 years of experience in regulatory affairs within the pharmaceutical industry.
- In-depth knowledge of Japanese pharmaceutical regulations and guidelines.
- Strong project management and organizational skills.
- Excellent communication and interpersonal skills.
- Proficiency in both Japanese and English (written and spoken).
- Ability to work independently and as part of a team.
- Attention to detail and a proactive approach to problem-solving.
