Position Summary:
The Regulatory Affairs Manager will lead regulatory assessment and execution of post-approval changes for products in Japan, collaborating with internal teams, global colleagues, and external partners to ensure compliant and timely change controls. This role involves evaluating CMC and related changes, determining regulatory pathways, defining data needs, and managing submissions such as partial and minor changes, notifications, and consultations. This role supports lifecycle management and works cross-functionally to maintain business continuity and compliance. A strong knowledge of Japanese pharmaceutical regulations, change control, CMC, quality concepts, and company procedures is essential to provide regulatory advice, risk assessment, and coordination for marketed products.
Key Accountabilities:-
Post-Approval Regulatory Change Control Strategy and Execution for Marketed Products
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Regulatory Compliance and Lifecycle Maintenance
Major Tasks & Activities:
1. Post-Approval Regulatory Change Control Strategy and Execution for Marketed Products
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Assess proposed post-approval changes for assigned products and determine the appropriate regulatory pathway in Japan, including partial change approval applications, minor change notifications, consultations, notifications, and authority responses as applicable.
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Lead regulatory impact assessments for CMC, manufacturing, testing, packaging, labeling, supply chain, and related operational changes, and define regulatory requirements, data gaps, implementation timing, and risk mitigation plans.
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Prepare, review, and coordinate high-quality regulatory documentation and submission packages for change controls, including preparation of FD application forms using Open Trusty, Gateway notifications, and submission of applications and other regulatory documents to health authorities, and ensure timely execution in collaboration with local and global stakeholders.
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Lead and/or support regulatory strategy and execution for lifecycle expansion activities for marketed products, including indication expansion and dosage and administration expansion, in alignment with business priorities and Japanese regulatory requirements.
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Provide practical regulatory guidance to internal and external stakeholders, including global teams and external clients, primarily overseas companies, on Japan-specific post-approval change requirements and implementation conditions.
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Lead and conduct interactions, negotiations, and consultations with health authorities (MHLW/PMDA), acting as a primary regulatory contact point.
- Lead and support post-approval change management across product modalities, including both small molecules and biologics, by applying appropriate regulatory strategies and data requirements based on product characteristics and change complexity.
2. Regulatory Compliance and Lifecycle Maintenance
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Maintain regulatory compliance for marketed products by tracking approvals, conditions, commitments, implementation timelines, and required submissions associated with lifecycle maintenance activities.
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Provide regulatory intelligence by monitoring and interpreting changes in Japanese pharmaceutical laws, regulations, guidance, and authority expectations, and proactively advising stakeholders on potential business impact and required actions.
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Participate in relevant industry association activities, including the Tokyo Pharmaceutical Manufacturers Association, to support regulatory intelligence gathering, external engagement, policy awareness, and internal communication of industry trends and implications.
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Support and/or lead post-marketing administrative consultations with health authorities for marketed products, including preparation of briefing materials, discussion points, meeting requests, and follow-up actions.
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Maintain regulatory aspects of business licenses and site registrations relevant to Japan operations, including Marketing Authorization Holder license, manufacturing site licenses, and Foreign Manufacturer Accreditation, by identifying required updates, coordinating submissions, and ensuring ongoing compliance.
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Assess, prepare, and coordinate drug supply instability reporting and related regulatory communications to health authorities in accordance with applicable Japanese requirements and internal escalation processes.
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Manage revisions and corrections of package inserts and other labeling-related documents for marketed products, including assessment of regulatory requirements, preparation and review of supporting documentation, and coordination of implementation with relevant stakeholders.
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Contribute to inspections, audits, SOP updates, training, and process improvements related to post-approval regulatory maintenance, change control governance, and supply continuity.
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Communicate regulatory status, risks, dependencies, and required actions clearly to management and cross-functional stakeholders, and support prioritization of activities based on compliance and business impact.
3. Other Regulatory Tasks
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Carry out other regulatory tasks and responsibilities as reasonably required from time to time
Requirements
- Strong knowledge of Japanese pharmaceutical regulations, post-approval change management, CMC concepts, and lifecycle maintenance requirements.
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Demonstrated ability to assess regulatory impact, manage competing priorities, and make pragmatic, risk-based recommendations.
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Minimum 5+ years of experience in regulatory affairs, CMC regulatory affairs, quality, pharmaceutical development, or other relevant functions, including experience with post-approval changes.
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Business level English and Japanese communication skills, including the ability to explain local regulatory requirements to global stakeholders.
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Bachelor’s degree or above in pharmacy, chemistry, biology, engineering, or another relevant scientific discipline.
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Preferred qualifications include experience with Japanese change submission categories (e.g., partial change approval, minor change notification, consultations), dossier preparation, authority interactions, cross-functional project leadership, and change management for both small molecules and biologics.
