The Regulatory Affairs Senior Manager / Manager role offers the opportunity to play a key role in bringing innovative therapies to patients by leading regulatory strategy and submissions in Japan. This position is ideal for an experienced regulatory professional who enjoys working in a global environment, partnering cross-functionally, and driving successful regulatory outcomes across a diverse portfolio of biologics and small molecules.
Responsibilities
Regulatory Strategy
Develop and implement regulatory strategies for portfolio assets, including biologics, small molecules, and lifecycle management activities, aligned with local and global business objectives.
Plan and execute regulatory interactions and expedited regulatory pathways in Japan in alignment with global strategies.
Ensure compliance with Japanese regulatory requirements, including PMDA and MHLW guidelines.
Regulatory Submissions and Approvals
Oversee the preparation, submission, and approval of regulatory dossiers in Japan, including CMC, clinical, and safety documentation.
Manage interactions and negotiations with PMDA to address regulatory queries and support timely approvals.
Global Collaboration
Act as the primary liaison between the local regulatory team and global regulatory affairs functions, ensuring alignment of strategies and processes.
Foster collaboration with global counterparts and cross-functional teams to achieve shared regulatory and business goals.
Regulatory Intelligence
Monitor and interpret changes in Japanese regulatory guidelines and communicate implications to relevant stakeholders.
Provide regulatory guidance and risk assessments to cross-functional teams, including R&D, manufacturing, and commercial functions.
Cultural Leadership
Promote teamwork and shared accountability to achieve regulatory and business objectives.
Demonstrate agility and adaptability in responding to regulatory challenges and evolving requirements.
Maintain a results-focused approach while ensuring compliance and high-quality regulatory standards.
Uphold integrity, transparency, and a psychologically safe environment for effective communication.
Requirements
Professional Competencies
In-depth knowledge of Japanese regulatory requirements and guidelines, including PMDA and MHLW regulations.
Familiarity with international regulatory frameworks, including ICH guidelines.
Proven experience as a regulatory strategy lead for projects in Japan.
Proven experience managing regulatory submissions and approvals in Japan.
Experience with biologics, small molecules, and regulatory CMC activities.
Preferably, leadership experience in building and developing high-performing teams.
Excellent communication skills with the ability to convey regulatory strategies to diverse stakeholders.
Strong collaboration skills and the ability to work effectively across cross-functional and cross-cultural teams.
Education
Preferably a licensed Pharmacist in Japan.
Experience
Minimum 8–10 years of experience in regulatory affairs within the pharmaceutical or biotechnology industry.
Proven track record of managing regulatory submissions and approvals with PMDA and MHLW.
Preferably experienced in overseeing regulatory CMC activities and ensuring compliance with local and global standards.
Preferably 3–5 years of managerial experience, including leading teams of regulatory professionals.
Experience working within multinational organisations or alongside global regulatory teams.
Preferred: 3 years or more experience in Patient Safety or Product Quality.
Business-level English communication skills, both written and verbal.
Benefits
Comprehensive welfare coverage.
Comprehensive insurance coverage.
About the Company
A company in the pharmaceutical industry, this global organisation focuses on developing innovative treatments for psychiatric and neurological disorders. With a long-standing commitment to advancing healthcare, the company works to improve patients’ lives through the development and delivery of pioneering therapies worldwide.