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Barcelona, Barcelona, España Galderma A tiempo completoJob Title: Regulatory Affairs CMC SpecialistWe are seeking a highly skilled Regulatory Affairs CMC Specialist to join our team at Galderma. As a key member of our Regulatory Affairs department, you will be responsible for preparing and updating CMC dossier sections for assigned products, contributing to global regulatory CMC strategies, and ensuring...
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Ra-Cmc Specialist
hace 3 meses
.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:Regulatory Affairs CMC SpecialistLocation:BarcelonaJob DescriptionWe are looking for an expert in Regulatory Affairs for preparing and updating the CMC (Chemistry, Manufacturing and Control) dossier sections of assigned products (Rx or non-monograph OTC drugs).This person will contribute to develop RA-CMC strategies for geographical extension and for post-approval CMC activities.Key ResponsibilitiesContribute to global regulatory CMC strategies.Assess regulatory impact of proposed CMC changes and contribute to the CMC regulatory strategies that support change implementation.Reviews data provided to support dossier preparation; identify gaps and risksand work with stakeholders to solve them.Writes/assembles CMC sections of regulatory submissions.Develop and maintain project plans and schedules for CMC submissions.Ensures all CMC dossiers are stored in the company database
