Regulatory Affairs Associate

Detalles de la oferta

.With a unique legacy in dermatology as well as decades of cutting-edge innovation, Galderma is the pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that spans the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermo-cosmetics, 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're 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.Further supporting our growth and innovation momentum, we are establishing a new Global Capability Center in Barcelona to deploy new capabilities to effectively support its global commercial and functional teams. Located in the upscale Eixample District in the heart of Barcelona, Galderma's Global Capability Center offers numerous possibilities for professional development such as exposure to global and cross-functional projects and access to global career opportunities.Job Title : Specialist, Regulatory Affairs StrategyLocation: Barcelona, Spain (hybrid)Job DescriptionThe Regulatory Affairs Strategist delivers innovative, breakthrough global regulatory strategies for clinical trial registration with health authorities. The RA Strategist is responsible for regulatory aspects related to clinical trial regulatory submissions in alignment with the global business strategy and in partnership with the functional subject matter experts within the Global R&D.Key ResponsibilitiesCreating and managing clinical trial regulatory strategy for biologics, executing clinical trial regulatory activities in alignment with agreed clinical timelines, including responses to health authority queries, amendments to clinical trial dossiers, regulatory SUSAR reporting, or any other regulatory activities as needed.Oversight of clinical trial regulatory submissions, ensuring accurate and compliant dossiers


Salario Nominal: A convenir

Fuente: Jobtome_Ppc

Requisitos

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