Regulatory Affairs Manager

Whether it's the unique breadth of our integrated offering that covers Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology products; or our commitment to recognizing and rewarding people for the contribution they make - working here isn't like anywhere else.

At Galderma, we actively give our teams reasons to believe in our 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.