Regulatory Affairs Sr Manager
hace 1 semana
Medison is a global pharma company providing access to highly innovative therapies to patients in international markets. Medison commercializes highly innovative therapies across international markets, helping to save and improve the lives of patients suffering from the most challenging diseases. Medison is rapidly growing in the international markets backed by more than 25 years of established operations in Israel, global infrastructure and partnership network. Medison is headquartered in Israel, with its international markets HQ in Switzerland and commercial hubs across the Baltics, Central and Eastern Europe, the Balkans, Greece as well as Canada, Latam and Australia. Requirements Minimum requirement: Bachelor’s Degree in Pharmacy Strong background in Regulatory Affairs, Pharmacovigilance, and Quality Assurance A minimum of 6+ years pharmaceutical industry experience with at least 4 years in Regulatory Affairs area, Technical Officer (responsible pharmacist), and PV in Argentina Experience in Uruguay, Chile, and Paraguay is a nice to have Experience with rare diseases and oncology drugs is appreciated Experience in a large innovative healthcare organization preferred Experience working with multinational staff organizations Experience in managing and interfacing effectively with CEO level stakeholders, negotiating and synthesizing messages Experience in hands‑on batch release activities Excellent local and English language and overall communication skills Strong problem solving and analytical skills Ability to work in a highly dynamic and fast‑growing organization with demonstrated capability to be at ease in a matrix structure and ability to influence Responsibilities Responsible for all regulatory activities in Argentina (South Cone – Chile, Uruguay, Paraguay), covering RA, PV and QA areas. Take an active part in building the QMS and procedures to cover the relevant GxP activities in the territory. In charge of developing, leading and managing all regulatory activities. Oversee all discussions and negotiations with local vendors and healthcare authorities. Prepare and execute the development of comprehensive plans for preparation and submission of regulatory submissions. Provide independent tactical/scientifically related guidance cross‑functionally on aspects of regulatory affairs. Use knowledge and experience in the regulatory field to influence functional objectives. Develop and implement SOPs in Argentina (South Cone – Chile, Uruguay, Paraguay). Review, approve and monitor all GxP related activities and ensure proper training for local employees. Serve as the Technical Officer to ANMAT and South Cone regulatory bodies and take regulatory responsibility for the products within the territory. Maintain a compliant and efficient Quality Management System, in accordance with local regulations and guidelines. Oversee pharmacovigilance activities in the territory in accordance with applicable regulations. #J-18808-Ljbffr
-
Regulatory Affairs Sr Manager
hace 2 semanas
Capital Federal, Buenos Aires, Argentina Medison Pharma A tiempo completoMedison is a global pharma company providing access to highly innovative therapies to patients in international markets. Medison commercializes highly innovative therapies across international markets, helping to save and improve the lives of patients suffering from the most challenging diseases._ - Medison is rapidly growing in the international markets...
-
Regulatory Affairs Manager
hace 2 semanas
Buenos Aires, Buenos Aires C.F., Argentina Kaizen Gaming A tiempo completo $900.000 - $1.200.000 al añoLet's start with the roleThe Regulatory Affairs Manager will oversee Kaizen Gaming's regulatory compliance and public affairs strategy, ensuring full adherence to gaming regulations while actively shaping policy at local and international levels. This role serves as the company's representative to regulators and industry stakeholders, driving compliance and...
-
Regulatory Affairs Sr Specialist
hace 7 días
Buenos Aires, Argentina Directa24 A tiempo completoRegulatory Affairs Sr Specialist - LATAM Johnson & Johnson At Johnson & Johnson, the largest healthcare company in the world, we come together for one purpose: to transform the history of health in humanity. Diversity & Inclusion are essential to continue building our history of pioneering and innovation, which has been impacting the health of more than 1...
-
Quality & Regulatory Affairs Manager
hace 2 semanas
Buenos Aires, Argentina Fullscript A tiempo completoQuality & Regulatory Affairs Manager Join to apply for the Quality & Regulatory Affairs Manager role at Fullscript. 1 week ago Be among the first 25 applicants. About Fullscript Founded in ****, Fullscript started by solving one problem: helping practitioners access and prescribe the products they trust to deliver integrative care. What began as a simple...
-
Quality & Regulatory Affairs Manager
hace 2 semanas
Buenos Aires, Argentina Fullscript A tiempo completoQuality & Regulatory Affairs Manager Join to apply for the Quality & Regulatory Affairs Manager role at Fullscript . 1 week ago Be among the first 25 applicants. About Fullscript Founded in ****, Fullscript started by solving one problem: helping practitioners access and prescribe the products they trust to deliver integrative care. What began as a simple...
-
Regulatory Affairs
hace 2 semanas
Capital Federal, Buenos Aires, Argentina Medison Pharma A tiempo completoMedison is a global pharma company providing access to highly innovative therapies to patients in international markets. Medison commercializes highly innovative therapies across international markets, helping to save and improve the lives of patients suffering from the most challenging diseases. Medison is rapidly growing in the international markets...
-
Senior Regulatory Affairs
hace 7 días
Buenos Aires, Argentina linscaninspection A tiempo completoA global pharmaceutical company is seeking a Regulatory Affairs & Pharmacovigilance Manager in Buenos Aires. The role involves managing regulatory affairs operations, establishing quality management systems, and acting as the Technical Director. Candidates must have a Bachelor's degree in Pharmacy and at least 6 years of pharmaceutical industry experience,...
-
Senior LATAM Regulatory Affairs Specialist
hace 7 días
Buenos Aires, Argentina Directa24 A tiempo completoA global healthcare company is searching for a Regulatory Affairs Sr Specialist to consult on documentation for submissions across LATAM markets. The role requires 3-4 years of experience in the regulatory environment and knowledge of LATAM regulations. Applicants should hold a Bachelor’s degree in life sciences. The position involves preparing...
-
Regulatory Affairs
hace 1 semana
Buenos Aires, Argentina linscaninspection A tiempo completoRegulatory Affairs & Pharmacovigilance Manager (Senior) Medison Pharma Medison is a global pharma company providing access to highly innovative therapies to patients in international markets. Medison commercializes highly innovative therapies across international markets, helping to save and improve the lives of patients suffering from the most challenging...
-
Cmc Regulatory Affairs Associate
hace 4 días
Buenos Aires, Argentina Parexel A tiempo completo**Join Our Growing Team of CMC Regulatory Professionals!** As we prepare for future growth, we are looking for Regulatory Affairs professionals with CMC experience to join a large, dedicated client FSP program. As a **CMC Regulatory Affairs Associate,** you will: - Play a crucial part in coordinating various Global regulatory submissions ie. INDs, IMPDs,...
