Regulatory Affairs Associate

hace 10 horas

Barcelona, España Galderma Pharma S.A A tiempo completo

.Regulatory Affairs Associate 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. 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. Job Title : Specialist, Regulatory Affairs Strategy Location: Barcelona, Spain (hybrid) Job Description The 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 Responsibilities Creating 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. Archiving clinical trial documentation. Managing health authority interaction for assigned regions in alignment with agreed regulatory strategy. Identifying and assessing risks associated with the clinical regulatory submissions and recommend strategies to mitigate these risks. Providing regular updates to global regulatory lead and indication regulatory leads regarding specific clinical trials. Managing of outside vendors. Skills & Qualifications Knowledge and understanding of regulatory requirements for pharmaceutical/biological product development. Experience with performing regulatory submissions in at least one key regulatory region. Experience with communicating the regulatory strategy, issues, and risks in written and verbal format to regulatory senior leadership team and other governing bodies. Experience interfacing with regulatory agencies and skill at implementing successful regulatory strategies. Experience with documenting regulatory strategies in coordination with clinical plans and marketing objectives

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