Planet Pharma
Job Description
Job Description: Title:
Senior Manager / Associate Director, Regulatory Affairs Location:
Tokyo, Japan Reports To:
Head of Regulatory Affairs - Innovative Medicines Employment Type:
Full-time, Permanent Employer : Top pharmaceutical company
Position Overview This position is responsible for developing and executing regulatory strategies for innovative pharmaceutical products in Japan. The role requires leadership in planning, preparing, and submitting key regulatory documents, including clinical trial notifications, consultation materials, and marketing authorization dossiers. The successful candidate will have a strong command of Japanese regulatory processes, a solid understanding of global development alignment, and experience engaging with health authorities in Japan.
Key Responsibilities
Regulatory Strategy & Submissions
Lead the development and implementation of regulatory strategies for products in development and registration phases. Develop robust, forward-thinking strategies aligned with both local and global regulatory objectives. Oversee preparation and submission of key documents including meeting requests, consultation materials, clinical trial notifications (CTNs), and new drug applications. Ensure all submissions meet regulatory standards and are delivered in accordance with agreed timelines and quality expectations. Health Authority Interaction
Plan, coordinate, and lead meetings and communications with Japanese regulatory authorities. Prepare briefing documents and responses to regulatory queries. Build and maintain productive, trust-based relationships with regulatory agencies. Cross-functional Leadership
Act as the primary regulatory representative for Japan in global and regional project teams. Collaborate closely with cross-functional departments (clinical, quality, medical, and commercial) to ensure compliance and alignment of regulatory activities. Identify operational gaps, propose solutions, and ensure implementation of best practices across teams. Compliance & Systems Management
Ensure all regulatory activities comply with local and international regulatory requirements and internal procedures. Maintain accurate documentation in internal systems, ensuring transparency and traceability of all submissions. Strategic Contribution
Contribute to global regulatory strategy discussions from the Japan perspective. Provide regulatory input on business development evaluations and product portfolio planning. Stay informed on evolving Japanese and international regulatory frameworks, providing insights to senior leadership.
Qualifications and Experience
Bachelor's or Master's degree in a scientific discipline (Pharmacy, Chemistry, Biology, Biotechnology, or related field). Minimum of 5 years' experience in regulatory affairs within the pharmaceutical or biologics industry. Demonstrated experience leading submissions and interactions with Japanese regulatory authorities. Strong understanding of CTN and NDA processes, including dossier preparation in CTD format. Familiarity with global regulatory standards and ICH guidelines. Proven project leadership and communication skills; capable of managing multiple priorities simultaneously. Fluent in Japanese (written and spoken); Business-level English required.
Working Model
Hybrid work arrangement available (Tokyo-based, with 2-3 office days per week). Must be employed as a full-time staff member (contract-based arrangements not applicable).
Candidate Profile
Candidates with regulatory affairs experience (including CMC) will be considered, even without prior strategic-level exposure. Open to Manager-level candidates with demonstrated leadership potential and technical expertise.
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it's from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.
Job Description: Title:
Senior Manager / Associate Director, Regulatory Affairs Location:
Tokyo, Japan Reports To:
Head of Regulatory Affairs - Innovative Medicines Employment Type:
Full-time, Permanent Employer : Top pharmaceutical company
Position Overview This position is responsible for developing and executing regulatory strategies for innovative pharmaceutical products in Japan. The role requires leadership in planning, preparing, and submitting key regulatory documents, including clinical trial notifications, consultation materials, and marketing authorization dossiers. The successful candidate will have a strong command of Japanese regulatory processes, a solid understanding of global development alignment, and experience engaging with health authorities in Japan.
Key Responsibilities
Regulatory Strategy & Submissions
Lead the development and implementation of regulatory strategies for products in development and registration phases. Develop robust, forward-thinking strategies aligned with both local and global regulatory objectives. Oversee preparation and submission of key documents including meeting requests, consultation materials, clinical trial notifications (CTNs), and new drug applications. Ensure all submissions meet regulatory standards and are delivered in accordance with agreed timelines and quality expectations. Health Authority Interaction
Plan, coordinate, and lead meetings and communications with Japanese regulatory authorities. Prepare briefing documents and responses to regulatory queries. Build and maintain productive, trust-based relationships with regulatory agencies. Cross-functional Leadership
Act as the primary regulatory representative for Japan in global and regional project teams. Collaborate closely with cross-functional departments (clinical, quality, medical, and commercial) to ensure compliance and alignment of regulatory activities. Identify operational gaps, propose solutions, and ensure implementation of best practices across teams. Compliance & Systems Management
Ensure all regulatory activities comply with local and international regulatory requirements and internal procedures. Maintain accurate documentation in internal systems, ensuring transparency and traceability of all submissions. Strategic Contribution
Contribute to global regulatory strategy discussions from the Japan perspective. Provide regulatory input on business development evaluations and product portfolio planning. Stay informed on evolving Japanese and international regulatory frameworks, providing insights to senior leadership.
Qualifications and Experience
Bachelor's or Master's degree in a scientific discipline (Pharmacy, Chemistry, Biology, Biotechnology, or related field). Minimum of 5 years' experience in regulatory affairs within the pharmaceutical or biologics industry. Demonstrated experience leading submissions and interactions with Japanese regulatory authorities. Strong understanding of CTN and NDA processes, including dossier preparation in CTD format. Familiarity with global regulatory standards and ICH guidelines. Proven project leadership and communication skills; capable of managing multiple priorities simultaneously. Fluent in Japanese (written and spoken); Business-level English required.
Working Model
Hybrid work arrangement available (Tokyo-based, with 2-3 office days per week). Must be employed as a full-time staff member (contract-based arrangements not applicable).
Candidate Profile
Candidates with regulatory affairs experience (including CMC) will be considered, even without prior strategic-level exposure. Open to Manager-level candidates with demonstrated leadership potential and technical expertise.
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it's from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.