International Regulatory Affairs Specialist (Pharma) en Madrid , España

Excellent opportunity to keep growing your professional career as a International RA Specialist for LATAM region

Client Details

European Pharmaceutical Company

Description

• 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)

Profile

• 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

Job Offer

• 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.