Regulatory Affairs Manager, Japan

The Opportunity:

This role offers the opportunity to contribute to the development of innovative precision oncology therapies by supporting regulatory strategy, health authority interactions, and regulatory submissions in Japan.

The Regulatory Affairs Manager, Japan will support assigned development programs and products, working closely with cross-functional teams and global regulatory colleagues to ensure successful execution of regulatory activities.

Key Responsibilities

Regulatory Strategy & Execution

• Support the development and execution of regulatory strategies for assigned programs and products in Japan.

• Assess regulatory requirements and provide recommendations to support development and registration activities.

• Monitor changes in the regulatory environment and communicate potential impact to project teams.

Health Authority Interactions & Regulatory Submissions

• Support the preparation and execution of PMDA consultations and regulatory interactions.

• Contribute to the preparation of briefing packages, regulatory responses, and submission documents.

• Support NDA/J-NDA submissions and post-approval regulatory activities.

Cross-Functional Collaboration

• Partner with Clinical Development, Clinical Operations, Medical Affairs, Safety, CMC, Quality, and other functions to support regulatory objectives.

• Participate in global project teams and contribute Japanese regulatory perspectives.

Vendor & CRO Management

• Coordinate activities performed by regulatory consultants, vendors, and CRO partners.

• Monitor timelines, deliverables, and quality of outsourced activities.

Required Skills, Experience and Education:

• Bachelor's degree in Life Sciences, Pharmacy, Medicine, or a related discipline.

• Typically 5+ years of pharmaceutical or biotechnology industry experience, including Regulatory Affairs experience.

• Familiarity with Japanese pharmaceutical regulations and drug development processes.

• Experience supporting regulatory submissions and health authority interactions.

• Strong communication and organizational skills.

Preferred Skills:

• Oncology drug development experience.

• Experience supporting PMDA consultations.

• Experience with NDA/J-NDA submissions.

• Experience working on global development programs.

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