• Generic Drugs (inyectable, solid, semi-solid)
• Barcelona or Madrid based (100% remote)

¿Dónde vas a trabajar?

European Pharmaceutical Company.

Descripción

• 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.

¿A quién buscamos (H/M/D)?

• 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).
• Advanced English level and Spanish native

¿Cuáles son tus beneficios?

• 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.