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Job Overview:
The Regulatory Compliance Specialist plays a crucial role in ensuring the compliance of manufacturing sites with GMP regulations in Japan. This involves collaborating with stakeholders to maintain the accuracy and integrity of approval files.
- GMP Compliance Inspection: Ensure timely collection of required documents and information for inspections.
- Communication: Maintain effective communication with manufacturing sites and stakeholders to ensure compliance.
The ideal candidate will have strong quality standards knowledge, effective communication skills, and the ability to manage critical information and track document timelines.
Key Responsibilities:
- Partial Change Application (PCA) Inspections: Collect required information for changes post-drug approval.
- New Drug Application (NDA) Inspections: Collaborate with stakeholders to ensure compliance of new drug approvals.
- Periodic Inspections: Conduct regular checks on manufacturing sites every five years.
Required Skills and Qualifications:
- Quality Standards and Design Principles: Knowledge of quality standards and design principles.
- Effective Communication and Collaboration: Ability to communicate effectively with stakeholders and collaborate with manufacturing sites.
- Information Management: Ability to manage critical information and track document timelines.
- Continuous Learning and Improvement: Continuous learning and improvement mindset.
