Senior Manager - Associate Director, Regulatory Strategy

About the Company

Our client is a global biopharmaceutical company focused on developing innovative therapies for serious diseases. With a robust clinical pipeline and a growing international presence, the organization is committed to advancing science, improving patient access, and delivering meaningful healthcare solutions worldwide.

Position Summary

Will lead the development and execution of regulatory strategies to support clinical development, product registration, and lifecycle management in Japan. Working closely with global and local cross-functional teams, this role ensures regulatory activities align with business objectives while maintaining compliance with Japanese regulatory requirements.

The successful candidate will provide strategic regulatory leadership across development programs, manage interactions with Japanese health authorities, and contribute to regulatory excellence through process improvements and team development.

Key Responsibilities

• Develop and execute regulatory strategies for clinical development, product registration, and lifecycle management in Japan.
  


• Provide strategic regulatory guidance throughout all stages of product development, including post-approval activities.
  


• Prepare, review, and oversee regulatory submissions, ensuring compliance with Japanese regulatory requirements and project timelines.
  


• Lead interactions with Japanese regulatory authorities, including regulatory meetings, submissions, and issue resolution.
  


• Advise cross-functional teams on Japanese regulatory requirements, risk assessment, and regulatory strategy.
  


• Monitor changes in the Japanese regulatory landscape and assess their impact on development programs and business objectives.
  


• Support the preparation and review of regulatory documentation for clinical trial applications, marketing applications, and post-approval submissions.
  


• Drive regulatory process improvements and promote best practices within the organization.
  


• Mentor, develop, and manage regulatory team members, fostering a collaborative and high-performing environment.
  


• Partner effectively with internal stakeholders and external collaborators to support successful product development and commercialization.
  

Preferred Qualifications

• Significant experience in Regulatory Affairs within the pharmaceutical or biotechnology industry.
  


• Strong knowledge of Japanese regulatory requirements, drug development, and registration processes.
  


• Experience leading regulatory strategies across multiple stages of product development.
  


• Proven ability to manage interactions with Japanese health authorities.
  


• Strong leadership, project management, and cross-functional collaboration skills.
  


• Excellent communication and stakeholder management abilities.
  


• Experience mentoring or managing regulatory professionals is preferred.
  

Requirements

Benefits

• Competitive compensation package, including performance-based incentives.
  


• Equity participation or long-term incentive opportunities (where applicable).
  


• Comprehensive benefits package.
  


• Ongoing learning and professional development opportunities.
  


• A collaborative, inclusive, and high-performing global work environment.
  


• The opportunity to contribute to the development of innovative therapies that improve patient outcomes worldwide.
  

Diversity & Inclusion

Our client is an equal opportunity employer committed to fostering a diverse and inclusive workplace. Employment decisions are based on qualifications, experience, merit, and business needs, without regard to any protected characteristic under applicable law.

Core Leadership Competencies

Successful candidates are expected to demonstrate:

• Collaboration and teamwork
  


• Clear and effective communication
  


• Integrity and constructive feedback
  


• Self-awareness and accountability
  


• Inclusivity and respect for diverse perspectives
  


• Initiative and ownership
  


• Entrepreneurial and solution-oriented thinking
  


• Continuous learning and adaptability
  


• Analytical and strategic problem-solving
  


• Results orientation and execution excellence
  


• Sound business and financial acumen
  


• Resilience in a dynamic, fast-paced environment