Seeking a highly experienced Regulatory Affairs professional to manage regulatory activities for parenteral (injectable) products across the LATAM region.
Experience in Pharmaceutical Regulatory Affairs, prepare & submit Regulatory documentation to authorities, Compile original ANDA modules submission knowledge of changing FDA requirements for solid oral, injectable, MDI.
The global pharmaceutical industry is undergoing a massive transformation. Moving beyond traditional drug manufacturing, the sector is now driven by biotherapeutics, digital health, data analytics, and patient-centric care models. This shift has created an urgent demand for professionals who not only understand pharmaceuticals but can also lead businesses strategically.
This role is pivotal in managing activities pertaining to product lifecycle management, quality management and pharmacovigilance, including variations and renewals, SOP development, risk management, and trainings.
Experience and expertise in authoring, compiling and submission of country specific submissions (MAA,BLA, and post approval changes) of Biologics/Biosimilar products in various markets- Regulated (EU/US/Canada) and emerging markets.
Contributes to the development and implementation of regulatory strategy for assigned region as a member of the Global Regulatory Affairs functional team
Expected M.Pharm by education with 3+ years experience for Document requisition and review, Dossier Preparation, CTD, ACTD, Country specific for ROW Market