Regulatory Affairs Sr Manager

Description
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.
ResponsibilitiesJob Description The Regulatory Affairs Sr Manager will be 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.
Manage all regulatory activities and oversee discussions and negotiations with local vendors and health care authorities.Thrive in an environment of rapid change; work effectively within cross-functional teams; possess a passion for highly innovative therapies that can dramatically improve patients' lives.Prepare and execute comprehensive plans for the preparation and submission of regulatory submissions.
Provide independent tactical/scientific guidance cross-functionally on aspects of regulatory affairs.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.RequirementsRequired Education and Experience: Minimum requirement: Bachelor's Degree in PharmacyStrong background in Regulatory Affairs, Pharmacovigilance, and Quality AssurancesA 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 haveExperience with rare diseases and oncology drugs is appreciatedExperience in a large innovative healthcare organization preferredExperience working with multinational staff organizationsExperience in managing and interfacing effectively with CEO Staff level stakeholders, negotiating and synthesizing messagesExperience in hands-on batch release activitiesExcellent local and English language and overall communication skillsStrong problem solving and analytical skillsAbility to work in a highly dynamic and fast-growing organization with demonstrated capability to be at ease in a matrix structure with ability to influence
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