Tengo una nueva vacante como Regulatory Affairs Technician (sólidos) para una importante empresa farmacéutica.
El puesto es indefinido y hay muy buen ambiente laboral, además ofrecen muchas oportunidades de promoción.
La vacante es office based con un día de teletrabajo a la semana.
Responsibilities Stay updated on changes in legislation and regulations and advise on the potential impact to product registration, marketing, manufacturing, or development.
Advise the R&D team on regulatory requirements for registration dossiers.
Compile required information for registration dossiers.
Submit registration and follow up with Health Authorities and Licensees until product approval and launch.
Collaborate with the marketing team to achieve objectives for launching any product.
Coordinate and prepare answers to deficiency letters received from Health Authorities.
Maintain regulatory files/database and chronologies in good order.
Establish and maintain a system for tracking changes in documents submitted to agencies or licensees.
Collaborate with Technical-Admin RA in reviewing product labeling for compliance with regulatory requirements.
Review and advise on product changes for impact on regulatory filings worldwide.
Provide technical support to the sales department with the technical requirements of customers.
Serve as regulatory liaison throughout the product lifecycle.
Serve as regulatory representative to marketing, R&D teams, and regulatory agencies.
Submit dossiers during first submission waves.
Collaborating in New Opportunities Submission of new dossiers (EU/out of EU).
Submission portfolio products.
Requirements At least 3 years of experience working in Regulatory Affairs with CMC/module 3.
Experience with solids is considered an advantage.
Fluent in Spanish and good level of English.
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