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Regulatory Affairs Technician (LATAM)

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Description

About the role

Do you want to take the next step in your career in Regulatory Affairs with a focus on LATAM? In this role, you will assume a key role in international regulatory strategy, leading dossier management, the preparation of technical documentation, and the coordination of sanitary registrations in different countries, with a high level of autonomy and responsibility in a dynamic and global environment.

What you'll do

  • In your day-to-day: -You will lead the regulatory strategy for LATAM markets, ensuring compliance with the sanitary requirements and regulations of each country. -You will manage the registration processes for new products, coordinating the preparation, review, and submission of regulatory dossiers to the corresponding sanitary authorities. -You will supervise the preparation, adaptation, and updating of technical dossiers. -You will coordinate regulatory variations, renewals, transfers of ownership, and other modifications related to the product lifecycle. -You will maintain fluid communication with subsidiaries, distributors, local partners, and sanitary authorities to ensure the correct development of regulatory procedures. -You will monitor the progress of procedures and submitted applications. -You will review and coordinate modifications to labeling, regulatory texts, packaging materials, and other technical documentation. -You will identify legislative and regulatory changes in different markets, evaluating their impact on products and defining the necessary actions to ensure regulatory compliance.

What we're looking for

  • You are the person we are looking for if: - You have a Degree in Pharmacy or similar. - You have more than 7 years of experience as a Regulatory Affairs Technician in the pharmaceutical industry. - Your experience has been in Rest Of The World markets. - Your English level is B2 or higher.

What you'll get

  • We offer: - Permanent contract. - Full-time working day from Monday to Thursday. Intensive Friday. - Flexible start and end times. - Hybrid work modality. - Competitive salary + variable. - Social benefits.

Skills

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