(Senior) Project Manager / 薬事申請プロジェクトマネージャー

About This Opportunity

We are representing a confidential pharmaceutical consulting organization with a strong presence in Japan. Our client works primarily with international biotech companies, supporting new drug development from strategic planning through regulatory approval. We are seeking a (Senior) Project Manager to lead regulatory submission projects in the Japanese market.

This role offers exposure to the complete drug development lifecycle, including regulatory requirement comparisons across countries, PMDA consultation coordination, key opinion leader engagement, and CTD documentation support. You will serve as the primary liaison between clients and consulting teams, managing all aspects of project delivery from inception to completion.

Responsibilities

• Serve as the primary point of contact for clients, confirming business requirements including statements of work, budgets, and expectations
• Understand and define project scope and requirements based on client needs
• Schedule and facilitate client meetings to discuss regulatory service needs, identify issues, and develop strategic plans
• Manage timelines, costs, and resources throughout the entire project lifecycle from team formation to project closure
• Collect information from consultants and manage schedule and resource changes accordingly
• Set up required systems and tools according to SOPs and project management plans, including timecode configuration
• Coordinate and attend PMDA consultations
• Arrange and manage training requirements
• Prepare materials for project meetings
• Coordinate with vendors such as interpreters and provide necessary files
• Drive improvements in project efficiency and performance
• Create, analyze, and review budget management reports

What We're Looking For

Required qualifications:

• Strong problem-solving abilities
• Project leadership and management knowledge
• Excellent interpersonal and cross-cultural communication skills
• Client-focused approach to service delivery
• Demonstrated teamwork and collaboration capabilities
• Professional-level English communication skills (written and verbal)
• Proven project management experience

Preferred qualifications:

• Experience in the pharmaceutical industry

Career development: This position offers pathways to advance into regulatory consulting roles or expand into project leadership across multiple service areas. Your English skills will be utilized daily in this international environment.

Reporting structure: You will report to a manager based in Europe.

How We Work With You

Get A Job.ai is managing the full recruitment process for this confidential client. Here's how it works:

• Submit your application through the Get A Job.ai platform
• Our recruiting team will screen qualified candidates and conduct initial interviews
• We will present selected candidates to our client for consideration
• Please do not attempt to contact the client directly, as this may disqualify your application

Pay

Compensation details will be discussed with qualified candidates during the screening process based on experience level and qualifications.

Equal Employment Opportunity: Get A Job.ai is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.