Regulatory Affairs Manager

Job description

Galderma is the emerging pure-play dermatology category leader, present in approximately 90 countries. We deliver 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 our foundation in 1981, we have dedicated our focus and passion to the human body's largest organ - the skin - meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals. Because we understand that the skin, we are in shapes our lives, we are advancing dermatology for every skin story. We look for people who focus on getting results, embrace learning and bring a positive energy. They must combine initiative with a sense of teamwork and collaboration. Above all, they must be passionate about doing something meaningful for consumers, patients, and the healthcare professionals we serve every day. We aim to empower each employee and promote their personal growth while ensuring business needs are met now and into the future. Across our company, we embrace diversity and respect the dignity, privacy, and personal rights of every employee. At Galderma, we actively give our teams reasons to believe in our bold ambition to become the leading dermatology company in the world. With us, you have the ultimate opportunity to gain new and challenging work experiences and create an unparalleled, direct impact. Profile Requirements Education/Training: Bachelor's degree in Pharmacy, Pharmaceutical Sciences, Chemistry, Biology, or other relevant Life Sciences discipline. A Master's degree is an advantage. Work Experience: Minimum 8 years of progressive Regulatory Affairs experience in the cosmetics and/or quasi-drugs industry, including direct responsibility for product registrations and lifecycle management in Japan. Experience working in an international matrix organisation Strong knowledge of Japanese regulations and registration requirements governing cosmetics and quasi-drugs, including product notifications, licensing requirements, labeling, advertising and claims compliance, ingredient regulations, and post-market obligations. Demonstrated experience leading end-to-end regulatory assessments, submissions, registrations, approvals, and lifecycle maintenance activities for cosmetics and quasi-drug products in Japan. Experience interacting with Japanese regulatory authorities and industry associations regarding cosmetics and quasi-drug regulatory matters. Language: Fluent Japanese and business-level English communication skills. Required pre-requisites skills/experience for this position: Strong understanding of the commercial dynamics of the cosmetics and quasi-drugs industry, with the ability to provide pragmatic regulatory guidance that supports business objectives while ensuring compliance. Strong analytical and critical thinking skills, with the ability to assess complex regulatory issues, identify risks and opportunities, and develop effective solutions. Excellent communication, stakeholder management, and influencing skills, with the ability to build and maintain effective relationships with Health Authorities, industry associations, global functions, and cross-functional teams, while effectively communicating complex regulatory matters to both technical and non-technical audiences. Strong project management, planning, negotiation, and interpersonal skills, with the ability to effectively manage multiple priorities, deliver high-quality outcomes within agreed timelines. Ability to work independently and collaboratively in a matrix environment, driving alignment and influencing stakeholders to achieve shared objectives. Strategic mindset with the ability to anticipate regulatory developments, evaluate business impact, interpret evolving regulatory requirements, and provide actionable guidance to support product development, registration, commercialization, lifecycle management, and proactive regulatory strategies. Commitment to continuous improvement of regulatory processes, systems, and ways of working to enhance efficiency, compliance and organizational capability. Self-motivated, proactive, and results-oriented, with a strong focus on execution and the ability to drive initiatives through to successful completion. High level of integrity, professional credibility, and commitment to ethical conduct and compliance.