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..Job Description: We're looking for people who are determined to make life better for people around the world. Purpose: The Senior Director/Executive Director, Global Regulatory Affairs (GRA)-EMEA or Regional Regulatory Scientist is accountable to establish the local regulatory strategy and plan for assigned product(s) in region/country, ensure local plan aligns to the global regulatory strategy (i.E. RSD) and ensure local regulations and region/country business needs are included. The Senior Director/Executive Director, Global Regulatory Affairs (GRA)-EMEA Regional Regulatory Scientist is accountable to provide regional regulatory leadership and oversight in delivering high quality and efficient regulatory submissions, approvals,and local labelling for their assigned product(s). The Senior Director/Executive Director is responsible for leading meetings and other interactions with region/country regulators. The Senior Director/Executive Director, Global Regulatory Affairs (GRA)-EMEA Regional Regulatory Scientist performs regulatory evaluations of external business opportunities, as requested by management, and effectively manages alliance/CRO relationships in regulatory area. Primary Responsibilities: Regulatory Expertise for Assigned Program/Product(s) in Region/Country Provide region/country input and review of global strategic plans and global/regional submission plan and documents. Contribute during key governance committees on regional regulatory strategy decisions, if requested (e.G. when key discussion topics impact the region). Ensure approval and delivery of content for local regulatory submissions, engaging cross functional partners in contributing to development of submission content.Own relationship and lead meetings and interactions with regulators in assigned region and engage cross functional partners to contribute to regulator interactions. Influence the regulator in favor of the planned development. Lead development of local/regional labelling strategy (product information and packaging) and network for alignment across region/affiliate team to enable timely completion of registration milestones (i.E. submission, approval, and launch). Apply labelling expertise, competitor knowledge, and regulatory precedent to propose labelling content to influence commercially viable labelling in region/country. Lead team during negotiation with regulators by providing responses to labeling questions. Ensure compliance with all applicable regulations and internal quality systems.Provide up-to-date expertise on regional registration procedures. Interpret and anticipate impact of new guidelines and initiate change in response to changing environment. Own all regulatory activities in support of assigned marketed product(s) in the region/country El anuncio original lo puedes encontrar en Kit Empleo:Https://www.Kitempleo
