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About the Role

A global biopharmaceutical company is seeking a highly motivated and energetic professional to join its International Regulatory Affairs team. The role will be responsible for developing regulatory strategies, preparing and executing regulatory submissions and post-marketing activities in Japan, and providing regulatory insight and support for clinical development. The position will also serve as a key liaison with Japanese regulatory authorities and collaborate closely with regional and global teams.

Responsibilities

Develop Japanese regulatory filing strategies and identify potential risks and gating factors.
Lead the strategic planning and preparation of complex regulatory submissions, including new drug applications and post-marketing maintenance activities.
Ensure regulatory submissions are prepared in accordance with applicable Japanese regulations and requirements.
Serve as a primary liaison with Japanese regulatory authorities, including MHLW and PMDA, and support regulatory discussions and negotiations as required.
Lead the preparation for and execution of regulatory agency meetings.
Work closely with cross-functional global teams and international colleagues to align on strategic and operational deliverables.
Monitor and evaluate new and emerging Japanese regulations and guidance, advising internal stakeholders on potential impacts to products and development plans.
Contribute regulatory expertise and strategic input to clinical development activities in Japan.

Requirements

Bachelor’s degree in life sciences or a related field.
Pharmacist qualification is a plus.
Fluency in Japanese and English.
10+ years of relevant industry experience, including significant Regulatory Affairs experience within the pharmaceutical or biotechnology industry.
Strong knowledge and understanding of the Japanese regulatory environment.
Proven experience preparing, submitting, and obtaining approvals for Japanese regulatory applications.
Thorough understanding of relevant drug development regulations and guidelines.
Strong written and verbal communication, presentation, planning, and coordination skills.
Experience in clinical development and/or strong understanding of clinical development processes is highly desirable.
Strong proficiency with standard business software and tools.
Ability to collaborate effectively with stakeholders across Japan, APAC, and global teams.

Skills

Japanese regulatory filing strategies
Risk identification
Gating factor identification
Strategic planning
Regulatory submission preparation
New drug applications
Post-marketing maintenance
Japanese regulations
Regulatory requirements
Liaison with Japanese regulatory authorities
MHLW liaison
PMDA liaison
Regulatory discussions
Regulatory negotiations
Regulatory agency meetings
Cross-functional collaboration
International collaboration
Strategic alignment
Operational alignment
New regulation monitoring
Emerging regulation monitoring
Guidance monitoring
Impact assessment
Clinical development input
Regulatory expertise
Written communication
Verbal communication
Presentation skills
Planning skills
Coordination skills
Clinical development experience
Business software proficiency
Business tools proficiency

Location

Tokyo

Work Type

Full-time

Experience Level

10+ years

Education Level

Bachelor's degree in life sciences or a related field
Pharmacist qualification

About the Company

A global biopharmaceutical company