Regulatory Affairs Manager - Latin America

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Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world.

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Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.

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We are searching for the best talent for Regulatory Affairs Manager to be in Mexico City, MX; Mendoza, AR; Bogotá, CO or São Paulo, BR.

Purpose: The Regulatory Affairs Manager for the Latin America region is responsible for the regulatory science and crafting the strategies to advance projects for early stages of research and develop submissions and approvals for initial marketing authorization applications and lifecycle managements of the products assigned.

This role involves working closely with local, global, and other cross-functional partners to ensure compliance with requirements and outstanding strategies for the assets in the market.

You will be responsible for:
• Performing the preparation, submission, and maintenance of filings.
• Collaborating with senior department members to expedite commercialization of new technologies, new indications and line extensions.
• Providing early inputs to identify barriers and needs to craft global development plan.
• Interpreting local and international requirements.
• Providing support to cross-functional teams and representing the company in interactions with authorities and industry associations.
• Collaborating with teams of varied strengths to ensure alignment and consistency in strategies and submissions.
• As the Regulatory Affairs Manager, you will play a crucial role in making a significant impact on public health and contributing to the successful access of innovative therapies for the LATAM population, being part of a team that values excellence, collaboration, and continuous learning.• Education Required: Licenciatura or Bachelor's degree
• Experience Required: At least 6 years of expe...