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Regulatory Affairs Technician-solidos-top Pharma
hace 2 semanas
Tengo una nueva vacante como Regulatory Affairs Technician (solidos) para una importante empresa farmaceutica, el puesto es indefinido y hay muy buen ambiente laboral, ademas ofrecen muchas oportunidades de promocion. La vacante es office based con un dia de teletrabajo a la semana.
**Responsibilities**:
To stay updated on changes in legislation and regulations and advises and gives interpretation on the potential impact to the product registration, marketing, manufacturing or development.
To advice R&D team on Regulatory requirements for registration dossier.
Compilation of required information for registration dossiers.
Registration submission and follow up with Health Authorities and Licensees, until product approval and launch. Collaborate with any submission with port marketing team to achieve the objective for launching any product
Coordination and preparation of Answers to deficiencies letters received from Health Authorities.
Maintains regulatory files/database and chronologies in good order. Establish and maintain system for tracking changes in documents submitted to agencies or licensees.
Collaborate with Technical
- Admin RA reviewing product labelling for compliance with regulatory requirements.
Review and advice on product changes for impact on regulatory filings worldwide.
Technical support to the sales department with the technical requirements of the customers.
Serves as regulatory liaison throughout product lifecycle.
Serves as regulatory representative to marketing, R&D teams and regulatory agencies.
Submission of dossiers during first submission waves.
**Collaborating in new opportunities**: submission new dossiers (EU/out of EU): submission portfolio products.
Audits
**equirements**:
At least 3 years of experience working on Regulatory Affairs with CMC/module 3
Experience with solids is considered an advantage
Fluent in Spanish and good level of English
**and personal skillsEducation**: Degree in Pharmacy, Chemistry or Biology. Master is a plus.Languages: Fluent Spanish and English, knowledge of other languages will be an asset.Experience (years/area): 1-4 years of experience in the same functions.Specific Knowledge: Very good knowledge of general pharmaceutical legislation and regulations, including GMP, and expertise in ICH guidelines and registration dossier CTD format content. Proficiency with standard software tools (Word, Excel, PowerPoint, Project, etc.).Travels: Occasionally
