Reporting to the Japan Leadership Team, the Head of RA leads regulatory affairs, quality, and vigilance functions in Japan, managing regulatory strategies, daily operations, and cross-functional collaboration. This role is responsible for ensuring compliance and product safety in the complex and evolving Japanese regulatory environment, with a focus on medical devices.
Responsibilities
Contribute regulatory expertise to business and organizational decision-making and support the achievement of business and people objectives as a key member of the Japan Leadership Team
Fulfill the responsibilities of the Marketing Authorization Holder General Manager ("Sokatsu") in accordance with applicable local regulations
Lead the development and execution of regulatory strategies in Japan, ensuring regulatory compliance, appropriate risk management, and successful product registrations
Oversee all regulatory operations, including license maintenance and vigilance system oversight, to ensure product safety and regulatory compliance
Partner with local and global stakeholders to promote understanding of Japan-specific regulatory requirements and align regulatory strategies with business priorities
Lead and develop the Regulatory Affairs, Quality, and Vigilance functions through people development, coaching, and organizational capability building
Remain actively involved in day-to-day regulatory activities while providing strategic leadership to support business needs
Provide strategic regulatory advice and guidance to the Japan leadership team
Take accountability for delivering project objectives by aligning regulatory strategies with business priorities while remaining actively involved in operational activities
Lead the development and execution of regulatory strategies in Japan and provide proactive recommendations regarding regulatory requirements, timelines, and feasibility
Actively support day-to-day regulatory operations to meet business needs
Perform Sokatsu responsibilities in accordance with applicable local regulations
Lead regulatory submissions, including new registrations and change applications, and manage interactions with health authorities to support business objectives
Ensure ongoing compliance of marketed products through lifecycle management activities, including change control, license maintenance, and labeling updates
Proactively identify regulatory risks and challenges throughout the product lifecycle and work cross-functionally to develop effective solutions
Review and approve promotional and non-promotional materials, including product labeling, to ensure compliance with local regulations, industry codes, and company policies
Communicate the status of regulatory applications and product changes to relevant local and global stakeholders in a timely manner
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Evaluate and update product labeling to ensure regulatory compliance while supporting commercial competitiveness and timely product launches
Maintain regulatory documentation, records, and databases, including Regulatory Information Management Systems (RIMS), to ensure accuracy and compliance
Maintain required business licenses and import permits
Develop and implement local SOPs, work instructions, and processes to bridge gaps between global policies and local regulatory requirements
Ensure local implementation of global regulatory SOPs and mandatory training requirements
Monitor regulatory developments, legislative changes, industry trends, and competitor activities and incorporate relevant insights into regulatory strategies
Support the introduction and launch of new products in collaboration with cross-functional teams
Build and maintain effective relationships with external stakeholders, including the Ministry of Health, Labour and Welfare (MHLW), Pharmaceuticals and Medical Devices Agency (PMDA), Tokyo Metropolitan Government (TMG), consultants, and distributors
Support regulatory inspections, audits, and assessments by health authorities and certification bodies
Support post-market activities as needed
Lead the company's compliance program and promote adherence to global guidelines as well as local laws and regulations
Foster a culture of integrity, ethics, and compliance throughout the organization
Monitor compliance with internal standards and applicable regulations governing interactions with healthcare professionals (HCPs)
Oversee the operation of the local vigilance system in compliance with global SOPs, third-party agreements, and local regulatory requirements
Review and approve local vigilance-related SOPs and supporting documentation
Act as Deputy Local Safety Officer and support the maintenance of a 24/7 vigilance coverage system
Ensure readiness for vigilance inspections and audits and support inspection activities as a key local contact
Lead, coach, develop, and motivate Regulatory Affairs, Quality, and Vigilance team members
Foster strong and collaborative working relationships across functions
Represent the company in relevant industry associations, working groups, or professional committees when required
Partner with corporate functions on trademark management and trade compliance matters
Ensure compliance issues are appropriately investigated, documented, and addressed through effective Corrective and Preventive Action (CAPA) management
Comply with all applicable laws, regulations, the Galderma Code of Ethics, company policies, and SOPs
Requirements
Bachelor's degree or above in Pharmacy, Life Sciences, Engineering, or a related discipline
Minimum 10 years of Regulatory Affairs experience within the medical device or pharmaceutical industries
Experience developing regulatory strategies, managing product registrations, and supporting lifecycle management activities within the medical device sector
Experience working within a global or matrix organization
Strong knowledge of regulatory requirements and approval processes for medical devices and pharmaceuticals in Japan
Experience leading or making significant contributions to product registrations from submission through approval
Experience interacting with regulatory authorities such as the Ministry of Health, Labour and Welfare (MHLW), Pharmaceuticals and Medical Devices Agency (PMDA), and Tokyo Metropolitan Government (TMG)
Working knowledge of Quality Management Systems (QMS), quality, and safety-related requirements, with experience partnering effectively across functions
Experience leading and developing small teams
Business-level proficiency in both English and Japanese, written and spoken
Good understanding of the commercial drivers of the health care industry, particularly consumer health products, and an associated ability to provide advice/guidance that takes these into consideration
Analytical skills and attention to detail with the capability to appropriately define issues, questions, and data and to propose solutions to address the issues with an appropriate sense of urgency
Excellent communication skills: good, positive, and proactive communication and the ability to foster excellent working relations with both internal and external customers, including Health Authorities, Industry Associations, and internal stakeholders
Skills such as project management, problem-solving, ability to present information in an easily understood format at internal and external meetings, good time management, negotiation, and interpersonal skills
Ability to work both independently (hands-on) and as part of a team as required
Ability to balance company commercial needs with compliance requirements
Ability to think strategically and innovatively for the resolution of regulatory issues, envisioning the future and deciding on strategic priorities
Commitment to continued improvement in function processes and performance
Self-starter who proactively contributes to a positive team attitude and highly productive work environment
Driving excellent execution and consequently delivering results
High level of integrity and credibility
Ability to combine strategic thinking with hands-on execution and lead by example
Ability to effectively communicate and promote understanding of QMS and regulatory requirements across the organization
Ability to build trust and collaborate effectively with diverse stakeholders
Open, transparent, and constructive communication style
Adaptability and resilience in a fast-paced and evolving business environment
Nice to have:
A valid pharmacist license in Japan
Experience within cosmetics sectors
Experience within aesthetics, dermatology, or related healthcare sectors
About the Company
Galderma is an emerging pure-play dermatology category leader, present in approximately 90 countries. It delivers an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermatological Skincare, and Therapeutic Dermatology. Since its foundation in 1981, Galderma has focused on the human body's largest organ, the skin, meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals. The company is advancing dermatology for every skin story, understanding that the skin we are in shapes our lives.
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