Regulatory Program Manager

4 weeks ago


London, Greater London, United Kingdom Novartis Farmacéutica Full time

{"h1": "Global Program Regulatory Manager", "p": "At Novartis Farmacutica, we are seeking a highly skilled Global Program Regulatory Manager to join our team. This role offers a unique opportunity to work on the development and implementation of global regulatory strategies for programs through development, registration, and post-approval in assigned regions.", "ul": [{"li": "Develop and implement global regulatory strategies for programs through development, registration, and post-approval in assigned regions."}, {"li": "Provide input to global program regulatory strategy, including regulatory designations and innovative approaches."}, {"li": "Coordinate regulatory readiness with other line functions, Country Organizations, and Regions, representing RA or leads in regional RA or cross-functional activities providing strategic input into cross-functional deliverables."}], "h2": "Key Responsibilities", "ul": [{"li": "Lead planning, preparation, and submission of clinical trials."}, {"li": "Lead implementation of the defined global registration strategy into regional submissions worldwide by country organizations."}, {"li": "Coordinate, plan, and prepare for submission of initial registrations and post-approval applications, and the preparation, review, and maintenance of local product information as assigned."}, {"li": "Lead regulatory activities during HA reviews, responding to questions and HA interactions."}], "h2": "Requirements", "ul": [{"li": "Science-based bachelor's degree, plus an understanding of pharmaceutical development, clinical trials."}, {"li": "Track record of involvement in regulatory or pharmaceutical development, in one or more major regions."}, {"li": "Compliance and Quality mindset."}, {"li": "Fluency in English."}], "h2": "Commitment to Diversity and Inclusion", "p": "Novartis Farmacutica is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve."}



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