Overall Purpose of the role
Regulatory Affairs in Japan is responsible for the local regulatory affairs function, ensuring compliance with Japanese regulatory requirements, and aligning strategies with global objectives. This role leads regulatory strategy in Japan for specific portfolio projects, incl. leading regulatory submissions and approvals, while fostering collaboration with cross-functional teams and global counterparts. The Senior RA specialist will be part of a team of regulatory professionals.
Future successor to HoD RA, who is responsible for driving performance, building capabilities, and contributing to Lundbeck’s mission of improving the lives of people living with brain diseases.
Key Responsibilities and Working Relationships
Geographical responsibility:
This role is local, based in Japan, but involves close collaboration with Lundbeck’s global regulatory affairs organization.
Management Responsibility:
• NA for Senior RA specialist function
• HoD function manage 4-5 individuals, and is responsible for the development, mentorship, and performance management of the regulatory affairs team.
Responsibilities:
1. Regulatory Strategy
• Develop and implement regulatory strategies for Lundbeck portfolio assets incl biologics, small molecules, and for lifecycle management in alignment with local and global business goals.
• Plan and execute regulatory interactions and expedited regulatory pathways in Japan as aligned with global
• Ensure compliance with Japanese regulatory requirements, including PMDA and MHLW guidelines.
2. Regulatory Submissions and Approvals
• Oversee the preparation, submission, and approval of Japan regulatory dossiers, including CMC, clinical, and safety documentation.
• Manage interactions and negotiations with PMDA to address regulatory queries and facilitate approvals.
3. Global Collaboration
• Establish primary liaison between the local regulatory team and global regulatory affairs, ensuring alignment of strategies and processes.
• Foster a collaborative mindset by working closely with global counterparts and cross-functional teams to achieve shared goals.
4. Regulatory Intelligence
• Monitor and interpret changes in Japanese regulatory guidelines and communicate implications to stakeholders.
• Provide regulatory advice and risk assessments to cross-functional teams, including R&D, manufacturing, and commercial teams.
5. Lundbeck Behaviors
• Collaborate to Win: Foster teamwork and shared accountability across the organization to achieve regulatory and business objectives.
• Agility and Adaptability: Show flexibility in handling regulatory challenges and adapting strategies to changing guidelines and business needs.
• Drive Performance: Maintain a results-oriented approach, ensuring timely submissions and approvals while upholding compliance standards.
• Act with Integrity: Uphold ethical standards and transparency in all regulatory dealings and communications. Ensure psychological safe environment for communication.
Working Relationships:
• Internal Stakeholders: Collaborate with R&D, manufacturing, quality assurance, and commercial teams to ensure alignment of regulatory strategies.
• External Stakeholders: Build and maintain relationships with PMDA, MHLW, and other regulatory authorities.
• Global Teams: Work closely with Lundb
Role Specific Competencies
Professional Competencies:
• In-depth knowledge of Japanese regulatory requirements and guidelines (PMDA and MHLW).
• Familiarity with international regulatory frameworks, including ICH guidelines.
• Proven experience as regulatory strategy lead for projects in Japan
• Proven experience with submissions and approvals in Japan, for, biologics, small molecules, incl. regulatory CMC activities.
• Preferentially – leadership skills with experience in building and developing high-performing teams.
• Excellent communication skills to effectively convey regulatory strategies to diverse stakeholders.
• Collaborative mindset and ability to work across cross-functional and cross-cultural teams.
Level of Education:
• Preferable: Licensed Pharmacist from Japan.
Required Experience:
• Minimum of 8–10 years of experience in regulatory affairs within the pharmaceutical or biotechnology industry.
• Proven track record of managing regulatory submissions and approvals in Japan with PMDA and MHLW.
• Preferably – experience with overseeing regulatory CMC activities and ensuring compliance with local and global standards.
• Preferably - at least 3–5 years of managerial experience, including leading teams of regulatory professionals.
• Experience working in a multinational organization or with global regulatory teams.
• Preferred: 3 years or more experience within Patient safety or Product Quality
• Communication in English required, written and verbal
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