Director of Regulatory Submissions (Global Pharma)

Director of Regulatory Submissions (Global Pharma)

Our client are a global Pharma group, recruiting a Director of Regulatory Submissions. You'll manage all aspects of the Japan regulatory submission process during the development / approval stage of new pharmaceutical products & ensure compliance with global regulations.

This is a management role, with team leadership responsibility.

Some details are confidential. For more information, please click "apply".

Responsibilities

• Lead & manage a team.
• Manage all aspects of regulatory submissions (incl. preparation, review, and timely filing of documents to regulatory agencies)
• Ensure compliance with relevant regulations / guidelines.
• Collaborate with other departments (eg. R&D, Clinical, and Quality Assurance).
• Identify areas for process improvement.

Qualifications

• +3 years of experience in regulatory affairs.
• Extensive experience in pharmaceuticals.
• Relevant degree (preferred).
• Understanding of regulatory requirements and guidelines.
• Team management ability.
• Must be fluent in Japanese.