Head of RA

About This Role

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
• 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

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. ``