規制業務・品質ディレクター（日本）

as Deputy Local Safety Officer, supporting 24/7 vigilance coverage Ensure readiness for vigilance-related audits and inspections People Leadership Lead, coach, and develop the Regulatory Affairs, Quality, and Vigilance team Build strong, collaborative relationships across functions Represent the company in relevant industry associations or professional committees as needed Requirements Education Bachelor's degree or above in Pharmacy, Life Sciences, Engineering, or a related field A valid pharmacist license in Japan is a plus Experience (required) 10+ years of Regulatory Affairs experience within the medical device and/or pharmaceutical industries Hands-on experience developing regulatory strategy, managing product registrations, and leading lifecycle management activities, particularly within medical devices Experience working within a global or matrix organization Solid knowledge of Japan's regulatory requirements and approval processes for medical devices and pharmaceuticals Experience leading a product registration from submission through to approval Experience engaging directly with regulatory authorities such as MHLW, PMDA, and/or the Tokyo Metropolitan Government Working knowledge of Quality Management Systems (QMS) and related quality/safety requirements, with experience partnering across functions Experience managing or leading a small team Nice to have Experience within the cosmetics sector Experience within aesthetics, dermatology, or a related healthcare sector Language Japanese: business-level proficiency or above (reading, writing, and speaking ) Basic daily conversational skills in English are sufficient Key Skills & Attributes Commercial understanding of the healthcare industry, particularly consumer health, and the ability to advise with that context in mind Strong analytical and problem-solving skills, with sound judgment on prioritization Excellent communication and stakeholder management skills Ability to balance business needs with compliance requirements Able to combine strategic thinking with hands-on execution and lead by example Adaptable and proactive in a fast-changing environment About the Organization Our client is a global healthcare company specializing in skin health, with an established consumer healthcare and aesthetic-medicine presence in Japan. Operating across international markets, the company brings a science-led, premium brand portfolio to both everyday skincare and clinic-administered aesthetic treatments. The Japan business has entered a growth phase in recent years, marked by renewed leadership and an expanding product portfolio across both areas. Location / Employment Type Location: Tokyo, Japan Employment Type: Full-time...