Regulatory Affairs Director

hace 2 días


Ciudad de México, Ciudad de México Novartis Farmacéutica A tiempo completo

About the Role

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As a Regulatory Affairs Leader at Novartis Farmacéutica, you will play a crucial role in ensuring compliance with regulatory requirements and maintaining the technical documentation change system.

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The ideal candidate will have experience managing global regulatory submission projects, providing strategic input on regulatory strategy, intelligence, and knowledge required to develop, register, and maintain global products.

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You will contribute to the implementation of global systems, tools, and processes to support global development projects and/or marketed products, frequent internal company and external contacts, and represent the organization on specific projects.

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Responsibilities include:

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  • Managing medium to small level global regulatory submission projects;\
  • Providing submission and contributing to the technical related regulatory strategy, intelligence, and knowledge required to develop, register, and maintain global products;\
  • Contributes to strategic and technical input/support to drive implementation of global systems, tools and processes to support global development projects and/or marketed products;\
  • Frequent internal company and external contacts;\
  • Represents organization on specific projects - Works on problems of moderate scope where analysis of situations or data requires a review of a variety of factors;\
  • Reporting of technical complaints/adverse events/special case scenarios related to Novartis products within 24 hours of receipt - Distribution of marketing samples (where applicable).\
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The successful candidate will have a strong background in regulatory affairs and excellent communication skills. You will be responsible for analyzing and evaluating data, extracting pertinent information, preparing information abstracts and executive summaries of material searched, and maintaining extensive knowledge of product information and continuous contacts with local, regional, and divisional customers.

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We offer a competitive salary range of $140,000 - $180,000 per year, depending on experience, plus benefits such as health insurance, retirement plan, and paid time off.

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If you are a motivated and detail-oriented professional looking for a challenging role in regulatory affairs, we encourage you to apply.



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