**Scope of the role** Possesses and applies comprehensive strategic and advanced knowledge, skills/abilities and understanding of the regulatory and legal frameworks, regulatory requirements, legislation, processes and procedures.Assesses links between global, societal and economic trends; stakeholder concerns and regulatory issues and requirements; and the implications for regulatory strategy Assesses all requirements and potential obstacles for market access and distribution (federal, provincial/territorial/state, reimbursement, Provides in-depth understanding and ability to incorporate regulatory strategies to expedite development for products intended for serious or life-threatening medical conditions or that address unmet medical needs (e.g. orphan, conditional approval, breakthrough therapy)Develops and manages programs that train stakeholders on current and new regulatory requirements to ensure organization-wide compliance Provides strategic input and technical guidance on global regulatory requirements to product development terms Provides knowledge and critical analysis of preapproval inspections, GCP inspections and clinical investigator relationships Ensures clinical and nonclinical data are consistent with the regulatory requirements and support the proposed product claims **Education / work experience** Typically, a minimum of 9 relevant RA years' experience**Knowledge / competencies** Leverages a well-grounded knowledge of applicable laws, regulations and policies to develop and execute plans and programsEnsures strategies, analyses, and plans consider anticipated long-range requirements and are not just based on the current situationDemonstrates the ability to build agreement and acceptance through an ability to present a compelling case for ideas, negotiate persuasively, and address disagreements constructively
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