Director of regulatory affairs
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 ResponsibilitiesPrepares 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 responsibilitiesRequired QualificationsMinimum 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.
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Director Of Regulatory Affairs
Há 2 horas
São Paulo, Brasil Multinational Pharmaceutical Company Tempo inteiroThe 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 ResponsibilitiesPrepares regulatory product strategies.Prepares and manages regulatory submissions, including new applications and amendments, annual...
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Director of Regulatory Affairs
2 semanas atrás
São Paulo, Brasil Multinational Pharmaceutical Company Tempo inteiroThe 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 ResponsibilitiesPrepares regulatory product strategies. Prepares and manages regulatory submissions, including new applications and amendments, annual...
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Director of Regulatory Affairs
2 semanas atrás
São Paulo, Brasil Multinational Pharmaceutical Company Tempo inteiroThe 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...
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Director of Regulatory Affairs
2 semanas atrás
São Paulo, Brasil Multinational Pharmaceutical Company Tempo inteiroThe 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...
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Director of Regulatory Affairs
3 semanas atrás
São Paulo, Brasil Multinational Pharmaceutical Company Tempo inteiroThe 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...
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Director of Regulatory Affairs
3 semanas atrás
São Paulo, Brasil Multinational Pharmaceutical Company Tempo inteiroThe 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...
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Director of Regulatory Affairs
2 semanas atrás
São Paulo, São Paulo, Brasil Multinational Pharmaceutical Company Tempo inteiroThe 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 ResponsibilitiesPrepares regulatory product strategies. Prepares and manages regulatory submissions, including new applications and amendments, annual...
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Head of Regulatory Compliance
2 semanas atrás
São Paulo, SP, Brasil beBeeRegulatory Tempo inteiro €100.000 - €120.000Director of Regulatory Affairs The Director of Regulatory Affairs is a crucial role within our organization, responsible for developing and implementing strategies to ensure regulatory compliance. This includes preparing regulatory product submissions, analyzing information impacting regulatory decisions, and seeking expert advice when necessary. About the...
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Associate Director, Regulatory Affairs
Há 5 dias
São Paulo, Brasil IQVIA Tempo inteiro**We are looking for a forward-thinking, metrics-driven leader with study start-up experience, who has served as a Department Head and brings cross-functional and strategic expertise. This role will involve managing 8-10 direct reports and requires strong financial acumen to drive success.** Job Overview Line Management responsibilities for a team of...
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Latin America Regulatory Expert
2 semanas atrás
São Paulo, SP, Brasil beBeeRegulatory Tempo inteiroDirector of Regulatory Affairs The Director, Regulatory Affairs Latin America is a critical role responsible for developing and executing regulatory strategies that support our product portfolio. Develops and implements effective regulatory product strategies to ensure compliance with relevant regulations and guidelines. ,
