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Regulatory 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 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 Bachelor’s degree in Pharmacy (required) Strong background in Regulatory Affairs, Pharmacovigilance, and Quality Assurance Minimum of 6 years of experience in the pharmaceutical industry, including at least 4 years in Regulatory Affairs, Pharmacovigilance, and as a Technical Officer (Responsible Pharmacist) in Argentina. Experience in Uruguay, Chile, and Paraguay is preferred Experience with rare diseases and oncology products is preferred Hands‑on experience with batch release activities Strong problem solving and analytical skills Experience in a large, innovative healthcare organization is preferred Experience working within multinational and cross‑cultural team environments Demonstrated ability to engage effectively with executive‑level stakeholders, including CEO staff, with strong negotiation and message synthesis skills Comfortable working in a fast‑paced, high‑growth environment, with a proven ability to navigate matrix structures and influence across functions Fluent in Spanish and English, with excellent communication skills Responsibilities Play a key role in establishing the Quality Management System (QMS) and developing procedures to ensure compliance with all relevant GxP activities in the region. Lead and manage all regulatory affairs operations, including oversight of interactions and negotiations with local vendors and health authorities. Serve as the designated Technical Director for Argentina. Drive the implementation of Medison’s new QA Laboratory in Argentina, including setup, operational readiness, and overseeing laboratory operations. Prepare and execute the development of comprehensive plans for the 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 and the South Cone region (Chile, Uruguay, Paraguay), review, approve, and monitor all GxP‑related activities, and ensure proper training for local employees. Oversee pharmacovigilance activities in the territory in accordance with applicable regulations. Thrive in a dynamic, fast‑paced environment, demonstrating adaptability, initiative, and a passion for highly innovative therapies that can dramatically improve patients’ lives. Msl ABBVIE GLOBAL MEDICAL AFFAIRS PURPOSE: Medical Science Liaisons (MSLs) are key members of the affiliate medical department. These field‑based roles focus on medical and scientific engagement with AbbVie stakeholders (including research and healthcare professionals, payers, and… Medical Lead Oncology Why Patients Need YouPfizer's Worldwide Medical and Safety colleagues play a key role in connecting evidence based medical decision support with colleagues and stakeholders to enable better health and treatment outcomes. Whether you are creating framework necessary to… Fso Ems Senior - Ey Global Delivery Services EY Role name and descriptionSenior - EMS (Engagement Management Services) Team in EY is responsible for providing key operational support to the Tax and Accounting practices which EY provides to its multinational clients. EMS offers the ease of managing clients (also referred… Indero Description:Projects Managers are crucial to the success of Clinical Trials managed by Indero. They are the main point of contact internally as well as externally, ensuring all activities and deliverables are completed on time, on budget, and as expected.Great project… Global Tax Reporting Services Assist/staff - Ey EY At EY, you’ll have the chance to build a career as unique as you are, with the global scale, support, inclusive culture and technology to become the best version of you. And we’re counting on your unique voice and perspective to help EY become even better, too. Join us and… #J-18808-Ljbffr
