Senior Director Global Regulatory Lead Early Clinical DevelopmentSenior Director Global Regulatory Lead Early Clinical Development
Our client, a global pharma company, is currently recruiting for a Senior Director Global Regulatory Lead Early Clinical Development to join their team on a permanent basis. As Senior Director Global Regulatory Lead Early Clinical Development, you will be the regulatory regional lead for assigned molecules in development. You will be responsible for driving the regulatory strategy for development in the US and Canada from discovery through the start of registration studies. You will partner with other global regulatory scientists to develop and execute global regulatory strategy outside the US and Canada. In this role, you will be expected to take reasoned risks and leverage innovative regulatory strategies that can accelerate the development of assigned molecules. This is a very exciting opportunity to join a company with a strong product portfolio and pipeline. This role offers hybrid working.
Responsibilities Provide leadership by developing and executing innovative regulatory strategiesWork independently in a role that demonstrates organizational influence within and across functions, influencing cross-functional teams on clinical development strategy and trial designAct as direct liaison with FDA and Health CanadaExecute high quality communications with regulators and internal customers to articulate and ensure understanding of the regulatory strategy and complex issuesActively seek to deepen regulatory knowledge through constant learningReadily share information and regulatory knowledge with othersEngage in, influence, and shape external environment initiatives related to portfolio assetsRequirements: Bachelor's degree in scientific area and at least 10 years of industry-related experience in regulatory affairs and/or drug development OR Advanced scientific degree (e.g., PhD, PharmD) with at least 8 years of industry-related experience in regulatory affairs and/or drug developmentKnowledge of FDA and Health Canada procedures and practices and awareness of evolving regulatory initiatives desirableDemonstrated deep knowledge of the drug development processDemonstrated ability to assess and manage risk in a highly regulated environmentDemonstrated strong written, spoken and presentation communication skillsDemonstrated ability to negotiate and influenceDemonstrated attention to detailDemonstrated effective teamwork skills; able to adapt to diverse interpersonal situations
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