Senior Regulatory Affairs Specialist for UK and Ireland

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. At Galderma we’re unique and we embrace difference. Whether it’s the unique breadth of our integrated offering that covers Aesthetics, Consumer, and Prescription products; or our commitment to recognising 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. Job Title: Regulatory Affairs Manager – UK & Ireland Location: London, UK – By 2027: 4 times a week office based Job Description Main purpose of the role: As a business partner/enabler, lead local Regulatory Affairs activities for medicinal products, and as applicable medical devices and cosmetics, ensuring regulatory compliance and supporting product registration and lifecycle management across the UK and Ireland. Key Responsibilities Lead regulatory activities for the registration and lifecycle management of Galderma products across the UK and Ireland. Develop and execute local regulatory strategies in partnership with Global and Regional Regulatory Affairs. Manage post-approval activities, including marketing authorisation transfers, variations, renewals, PSURs/PBRERs and changes to registered details. Support the successful launch and continued availability of products, collaborating with Marketing, Commercial, Supply Chain, Medical Affairs, Pharmacovigilance and other relevant functions. Review and approve promotional and non-promotional materials to ensure compliance with local regulations, industry codes and internal guidelines. Coordinate local artwork and packaging updates through Veeva PromoMats. Build and maintain effective relationships with the MHRA and HPRA, including regulatory submissions, pre-submission meetings and post-approval interactions. Monitor regulatory, legislative and industry developments and assess their impact on Galderma’s portfolio. Contribute regulatory expertise to health authority and GxP inspections and ensure compliance with applicable legislation and company procedures. Skills & Qualifications Degree-level qualification in Life Sciences or a related scientific discipline. Minimum 5 years of hands-on Regulatory Affairs experience across pre- and post-approval activities. Proven experience within a local affiliate environment covering both the UK and Ireland. Strong experience with medicinal products, including POM and P/OTC products. Demonstrated experience interacting with MHRA and HPRA, including regulatory submissions, pre-submission meetings and post-approval activities. Strong understanding of the pharmaceutical regulatory environment across the UK and Ireland. In-depth knowledge of the post-Brexit regulatory landscape, including the Windsor Framework and International Recognition Procedure (IRP). Experience working in a multinational pharmaceutical environment and collaborating with global and regional teams. Strong project management, communication and stakeholder management skills, with sound judgement, attention to detail and a proactive, collaborative approach. Fluency in English. What we offer in return At Galderma, we offer an opportunity to work with innovative dermatology products and treatments in a leading global company. The role provides broad exposure to local, regional and global Regulatory Affairs activities, with the opportunity to contribute directly to product launches, ongoing product availability and the growth of Galderma’s portfolio across the UK and Ireland. Next Steps If your application is successful and your profile is a match, we will invite you for a first virtual conversation with the recruiter. The next step is a virtual conversation with the Hiring Manager. The final step is a panel conversation with the extended team. Our people make a difference At Galderma, you’ll work with people who are like you. And people that are different. We value what every member of our team brings. Professionalism, collaboration, and a friendly, supportive ethos is the perfect environment for people to thrive and excel in what they do.