Registration of generic medicinal products already approved by SRA (EU, MHRA, Canada etc) in accordance with national regulations of the Brazil, Mexico, Columbia, Chile, Costa Rica, Argentina, Peru, Uruguay
Communication with state authorities and/or local agents during the registration process.
Supervision and maintenance of up-to-date registration documentation in the post-registration period: variations, renewals.
Responsibility for the transfer of registration (MAH transfer) within implementation timelines.
Close cooperation with Headquarter company management.
Coordinate where applicable the translations for SmPC, product labelling, artwork and patient information.
Keep records and files of Regulatory activities and databases.
Monitoring changes in legislation and regulations and ensuring their implementation in the company
In charge of the EU dossiers that will pass to LATAM, focused on modul 1 and 2 (module 3 / CMC will come from EU sites)
Main requirement for the candidate is the competency and knowledge to adapt EU dossier for LATAM countries.
Be able to answer questions about the module 3 documents adaption, programs and platforms used for adapting EU dossiers to LATAM standards.
Remote / Home Office 100% (Barcelona or Madrid based)
Unique opportunity to join the company in very exciting phase of business growth.
Extensive motivation program.
Dynamic work environment.
Career development opportunities, professional as well as personal growth.
Requisitos mínimos
University Degree in science, preferably in chemistry, pharmaceutical technology or pharmacy
Minimum 5 years experience RA Generics for LATAM region
In-depth understanding of regional and global regulatory requirements for pharmaceuticals.
Strong analytical and problem-solving skills.
Responsible and independent
Excellent communication and interpersonal skills.
Ability to work effectively in a team environment.
Exceptional attention to detail and organisational skills.
Ability to manage multiple projects and deadlines in a fast-paced environment.
Proficiency in Microsoft Office (e.g., Word, Excel, Outlook).
