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Regulatory Affairs Technician
Negotiable Salary
Indeed
Full-time
Onsite
No experience limit
No degree limit
C. Enrique O. de la Madrid 102, Donacar PRI, 28910 Madrid, Col., Mexico
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Description

- Responsible for the preparation, variation and maintenance of the company's product registration documentation (CTD drug dossiers, technical files for medical devices, DENT registrations, CPNP registrations). * Interact with Health Authorities, Regulatory Agencies and Notified Bodies; and participate in corresponding audits and inspections. * Manage relevant computer applications (RAEFAR, LABOFAR, AEMPS Telematic Submissions, CNCps, CESP Portal, Telematic Batch Editing). * Ensure that applicable technical documentation for the company, its suppliers and active ingredients remains valid (CEP, QP declaration, GMP or GDP certificates, ISO standards, CE Markings, Declarations of Conformity, Declarations of Equivalence...). * Manage authorizations for the export and import of medicinal products. * Review and control the company's product artworks to ensure compliance with applicable regulations and product authorization. * Participate in the review and declaration of medicinal product advertising. * Coordinate new product registrations in foreign countries, leading all regulatory-related activities. * Be part of the audit team Number of vacancies: 1 Work mode: On-site Contract type: Permanent Annual salary: To be determined "**Requirements** Medicinal product registrations (variations, MDR, DCP) Technical documentation for medical devices (MDR) Minimum education level Bachelor's degree in Health Sciences *Specialty:* Bachelor's degree in Pharmacy Languages Advanced level English. Minimum experience 3 years Willingness to travel 20% of working time

Source:  indeed View original post
Juan García
Indeed · HR

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