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About the Role
Galderma is a leading dermatology company focused on delivering innovative, science-based products across Injectable Aesthetics, Dermatological Skincare, and Therapeutic Dermatology. We are seeking a regulatory affairs professional to support our operations in Japan.
Responsibilities
- Lead end-to-end regulatory assessments, submissions, registrations, approvals, and lifecycle maintenance activities for cosmetics and quasi-drug products in Japan.
- Provide pragmatic regulatory guidance that supports business objectives while ensuring compliance.
- Manage multiple priorities and deliver high-quality outcomes within agreed timelines.
- Drive alignment and influence stakeholders to achieve shared objectives.
- Anticipate regulatory developments, evaluate business impact, and interpret evolving regulatory requirements.
- Provide actionable guidance to support product development, registration, commercialization, lifecycle management, and proactive regulatory strategies.
- Commit to continuous improvement of regulatory processes, systems, and ways of working.
Requirements
- Minimum 8 years of progressive Regulatory Affairs experience in the cosmetics and/or quasi-drugs industry.
- Direct responsibility for product registrations and lifecycle management in Japan.
- Experience working in an international matrix organization.
- Strong knowledge of Japanese regulations and registration requirements governing cosmetics and quasi-drugs.
- Experience interacting with Japanese regulatory authorities and industry associations regarding cosmetics and quasi-drug regulatory matters.
- Ability to work independently and collaboratively in a matrix environment.
Skills
- Product registrations
- Lifecycle management
- Japanese regulations
- Product notifications
- Licensing requirements
- Labeling
- Advertising and claims compliance
- Ingredient regulations
- Post-market obligations
- Regulatory assessments
- Submissions
- Approvals
- Commercial dynamics of the cosmetics and quasi-drugs industry
- Pragmatic regulatory guidance
- Analytical and critical thinking
- Risk identification
- Solution development
- Communication
- Stakeholder management
- Influencing skills
- Project management
- Planning
- Negotiation
- Interpersonal skills
- Strategic mindset
- Continuous improvement
- Self-motivated
- Proactive
- Results-oriented
- Execution focus
- High level of integrity
- Professional credibility
- Commitment to ethical conduct and compliance
Location
- Japan
Work Type
- Full-time
Experience Level
- 8+ years of progressive Regulatory Affairs experience
Education Level
- Bachelor's degree in Pharmacy, Pharmaceutical Sciences, Chemistry, Biology, or other relevant Life Sciences discipline
- Master's degree is an advantage
About the Company
- 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.