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3 semanas atrás
The Director, Regulatory Affairs Latin America is responsible for developing regulatory strategies and providing guidance to product development and commercial teams in support our products Portfolio. Key Responsibilities Prepares regulatory product strategies. Prepares and manages regulatory submissions, including new applications and amendments, annual reports, supplements and variations and responds to regulatory information. Analyzes and interprets information that impacts regulatory decisions. Seeks expert advice and technical support as required for strategies and submissions. Ensure the timely submission of NDAs, amendments, and supplements for assigned products/projects. Develops strategies for regulatory agency meetings. Manages preparation for agency meetings, and content of pre-meeting submissions. Serves as the point of contact for the regulatory agency meetings. Manage products and change control with an understanding of regulations and company policies and procedures. Analyzes and approves manufacturing change requests. Represents regulatory affairs on cross-functional teams, for assigned projects; negotiates with and influences team members with support of management to maximize chances for first pass approval of regulatory submissions. Stays abreast of regulatory procedures and changes in regulatory climate. Analyzes legislation, regulation and guidance, provides analysis to the organization. Serve as the Regulatory Affairs representative on project teams; manage the progress of projects by providing direction, solutions, and feedback to the teams. Maintain awareness of and communicate changing regulatory agency requirements; provide training and regulatory intelligence to the organization, may include formal supervisory responsibilities Required Qualifications Minimum of 5 years of experience in Regulatory Affairs, managing Latin America scope. A minimum of a Bachelor's degree is required, pharmacy, Chemistry, Biology or Pharmacology. Experience with INDs, NDAs, ANDA and leading health authority meetings in Mexico and Brazil. Preferable other Latin America countries' authorities. Experience working with industry counterparts and trade association committees and task groups is preferred. Experience working in a matrix environment. Strong oral and written communication in English and Portuguese. Spanish is preferable. We ensure confidentiality.
