With a unique legacy in dermatology as well as decades of cutting-edge innovation, Galderma is the leading company solely dedicated to skin and advancing the future of dermatology. 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 to promote their personal growth all the 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 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 unparalleled, direct impact.
Job DescriptionAs a Senior Project Manager, Global Regulatory Affairs you are part of the global regulatory affairs department under the biologics team. You work on development plans for the prescription business unit and therefore advise and validate on the regulatory filing plan and tasks for the business outside of US and Europe.
Key ResponsibilitiesYou maintain a global regulatory filing plan, including input from local and regional regulatory representatives. Close collaboration with international colleagues on approval efforts is essential.You execute regulatory tasks for product development projects in line with corporate objectives, timelines, and budgets.You prepare documentation packages for global regulatory submissions ensuring completion, accuracy and quality and support the regions with health authority interactions, regulatory submissions and other activities required to support licensure.You provide project updates and risks to the regulatory leadership team and program directors across the organization, including the development of regulatory presentations to the product development project teams and pipeline council.You act as an enabler between the regional and global organization and represent the Regulatory Affairs organization on project teams, ensuring smooth collaboration between both internal and external stakeholders.You create, implement, and maintain continuous improvement projects and processes in compliance with the local and global landscape to increase efficiency across the organization.Skills & QualificationsYou have a Bachelor's in a scientific discipline and knowledge of the pharmaceutical or preferably the biotechnology industry in either a project manager role or within a regulatory affairs department.You have knowledge and understanding of regulatory requirements for pharmaceutical/biological product development and approval in more than one key region (US, LATAM, JPAC, EU, Middle East, Africa).You can communicate the regulatory filing plan, issues, and risks in written and verbal format to the regulatory senior leadership team and other governing bodies.You can manage vendors and interact with regulatory agencies.What We Offer in ReturnYou will be working for an organization that embraces diversity & inclusion and believes we will deliver better outcomes by reflecting the perspectives of our diverse customer base.You will receive a competitive compensation package with bonus structure and extended benefits.You will be able to work in a hybrid work culture.You will participate in feedback loops, during which a personalized career path will be established.You will be joining a growing company that believes in ownership from day one where everyone is empowered to grow and take on accountability.Process StepsSend your CV in English.If your profile is a match, we will invite you for a first virtual conversation with Talent Acquisition.The next step is a virtual conversation with the hiring manager.The final step is a panel conversation with the extended team.
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