R41248 Regulatory Manager or Associate

Today, Lonza is a global leader in life sciences operating across three continents. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world.

Job Responsibilities

• Regulatory compliance evaluation for hard capsules and their raw materials (mainly for health foods)
• Regulatory compliance evaluation for liquid-filled hard capsules and their raw materials
• Regulatory compliance evaluation for imported raw materials
• Compliance with regulatory changes
• Responses to regulatory authorities
• Maintenance of ISO 9001
• Maintenance of GMP
• Audit support
• Creation of regulatory parts for management reviews

Required Qualifications

Mandatory (MUST)

• 3+ years of quality assurance experience in the healthcare industry (pharmaceuticals, food, etc.)
• Communication skills in Japanese and English
• English proficiency (business level preferred, but not required)
• Problem recognition and resolution skills
• Goal achievement skills
• Management skills (for Manager position)

Desirable (WANT)

• 3+ years of experience in a pharmaceutical or food factory
• Knowledge and practical experience of pharmaceutical laws
• Knowledge of food-related regulations
• Pharmacist license

Desired Candidate Profile

• Self-motivated and growth-oriented
• Cross-functional communication skills
• Information sharing and collaboration with overseas locations
• Customer focus

• Stress tolerance
• Compliance with safety, health, and environmental management

Working Hours, etc.

• 8:15-16:30 (7.25 hours of actual work) or 9:00-17:15
• Annual holidays: Saturdays, Sundays, and holidays, 5 days off, and other calendar-based holidays

Every day, Lonza's products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.

People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.

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