Head of Regulatory Affairs (規制業務責任者)

Head of Regulatory Affairs - Tokyo, Japan

A leading pharmaceutical company that is currently in search of an experienced individual for their Head of Regulatory Affairs role in Tokyo. This integral position provides the chance to spearhead and shape the organization's regulatory compliance strategies and operations.

As the Head of Regulatory Affairs, you will:

• Direct and manage regulatory operations, ensuring compliance with applicable laws, regulations, and industry guidelines
• Maintain a robust knowledge of changes in regulatory requirements and interpretations
• Lead and guide regulatory strategic planning and decision-making
• Foster and cultivate solid relationships with Japanese regulators and industry representatives
• Oversee preparation and submission of comprehensive regulatory documents, ensuring strict adherence to Japan's pharmaceutical affairs act
• Promote regulatory awareness within the organization through training and communication

The successful candidate will possess:

• Proven experience in regulatory affairs or a similar role, within the relevant industry
• Exceptional knowledge of regulatory guidelines and laws
• Strong leadership skills and the ability to make strategic decisions
• Excellent communication and negotiation skills
• Strong analytical abilities and attention to detail
• Proficiency in English, both spoken and written