Develop and maintain integrated project plans for global regulatory submissions, ensuring adherence to scope, timelines, budgets, and quality standards.
Act as the primary regulatory timeline contact across Clinical, Nonclinical, CMC, Quality, and Commercial functions, fostering collaboration and alignment.
Identify and mitigate project risks, prepare teams for agency meetings, and lead responses to regulatory queries from global health authorities.
Centessa Pharmaceuticals is a clinical-stage company developing orexin receptor 2 agonists for narcolepsy and other sleep-wake disorders. As a wholly owned subsidiary of Eli Lilly and Company, it shares a culture of caring and impact with over 50,000 employees.
Lead end-to-end labeling activities across the product lifecycle for pre- and post-market products.
Guide global labeling strategy, document development, and cross-functional regulatory teams.
Provide strategic labeling expertise to support safe and effective product use and regulatory compliance.
A global regulatory affairs organization focused on pharmaceutical product labeling. It provides a collaborative, science-driven environment with cross-functional and international exposure.
Develop, implement, and monitor outcome-based reporting systems for high-risk diagnoses, patient groups, and care processes.
Collaborate with interdisciplinary teams to prepare quality reports for clinical departments and regulatory bodies.
Apply performance improvement methods like Lean Six Sigma and Rapid Cycle PDSA to enhance patient care outcomes.
Cooper University Health Care is a leading healthcare provider committed to extraordinary care and clinical innovation. With a large team of professionals, it offers competitive benefits and opportunities for career growth.