- Regulatory Affairs Manager
- Medison group in Buenos Aires, Buenos Aires, Ciudad Autónoma de, Argentina
- jobs
- 1 week ago
jobs description
Argentina
Medison group
A tiempo completo
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.
Responsibilities
Job Description
The Regulatory Affairs Manager will be responsible for all regulatory activities in Argentina (South Cone - Chile, Uruguay, Paraguay), covering RA, PV, and QA areas.
Build and oversee the QMS and procedures for relevant GxP activities in the territory.
Develop, lead, and manage all regulatory activities, including discussions and negotiations with local vendors and healthcare authorities.
Work effectively within cross-functional teams and thrive in a dynamic environment.
Prepare and execute comprehensive plans for regulatory submissions, providing guidance on regulatory affairs.
Develop and implement SOPs in Argentina (South Cone - Chile, Uruguay, Paraguay), review, approve, and monitor all GxP activities, and ensure proper training for local employees.
Serve as the Technical Officer to ANMAT and other South Cone regulatory bodies, taking regulatory responsibility for products within the territory.
Maintain a compliant and efficient Quality Management System in accordance with local regulations.
Oversee pharmacovigilance activities in the territory per applicable regulations.
Requirements
Required Education and Experience:
Strong background in Regulatory Affairs, Pharmacovigilance, and Quality Assurance.
Minimum of 6+ years in the pharmaceutical industry, with at least 4 years in Regulatory Affairs, Technical Officer (responsible pharmacist), and PV in Argentina. Experience in Uruguay, Chile, and Paraguay is a plus.
Experience with rare diseases and oncology drugs is appreciated.
Experience in a large innovative healthcare organization preferred.
Experience working with multinational teams and managing relationships with senior stakeholders.
Hands-on experience with batch release activities.
Excellent communication skills in local language and English.
Strong problem-solving and analytical skills.
Ability to work effectively in a fast-paced, matrix organization and influence stakeholders.
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