Regulatory Affairs & Quality Assurance Manager (Senior)

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.

We are seeking a Regulatory Affairs & Quality Assurance Manager (Senior) to lead regulatory, pharmacovigilance (PV), and quality assurance (QA) activities in Argentina and the South Cone region (Chile, Uruguay, Paraguay). This role will also serve as the local Technical Director and play a key role in establishing Medison’s QA Laboratory in Argentina.

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 local Technical Director.
• 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.

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 Director (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