Gk-823 International Regulatory Affairs (Brazil & Mexico)

Global Responsibility: Support new regulatory submissions and assist with the lifecycle management of the existing portfolio, ensuring that any variations and/or renewals are submitted on time to maintain regulatory compliance.Specific Responsibilities:Support and provide the necessary documentation to local affiliates and clients for national submissions.Assist local affiliates and clients in responding to the LoDs with the aim of receiving the MA as soon as possible.Prepare the necessary documentation needed for the submission of administrative, quality, and safety variations.Submit renewals in a timely manner and communicate timelines with all partners.Archive essential documents, such as product information, and ensure quality parts of the dossier are archived and updated in line with company procedures.Ensure that essential information from the dossier post-approval is shared with implicated departments according to relevant procedures.Maintain the regulatory database up to date for projects in the region.Stay informed on the latest regulatory requirements in the region.Inform interested parties, such as commercial, business development, and top management, about the regulatory status in the respective area.Requirements and Personal Skills:Education: Degree in Health Sciences (preferably Pharmacy, but also Chemistry, Biology, Biochemistry, Veterinary or similar).Languages: Fluent in Spanish and English. Knowledge of other languages will be an asset; Portuguese is desirable.Experience: 5+ years in relevant field.Specific Knowledge: Knowledge in eCTD dossier; preferably have previous experience with generic or branded generics. Knowledge of International Standards in drug registration and Brazilian and Mexican legislation is required.Personal Skills: Initiative and proactivity, ability to make decisions autonomously, and decisiveness.#J-18808-Ljbffr