Regulatory Affairs Sr Manager

at  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:

REQUIRED EDUCATION AND EXPERIENCE:

• Minimum requirement: Bachelor’s Degree in Pharmacy
• Additional requirements: strong background in Regulatory Affairs, Pharmacovigilance and Quality Assurances
• 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 appreciate
• Experience in a large innovative healthcare organization preferred
• Experience working with multinational staff organizations
• Experience in managing and interfacing effectively with CEO Staff 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 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
• 
  Responsibilities:

JOB 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.

• He/she will take an active part of building the QMS and procedures to cover the relevant GxP activities in the territory. Will be in charge of developing, leading and managing all regulatory activities. S/He will also oversee all discussions and negotiations with local vendors and the health care authorities.
• The successful candidate will have the ability to thrive in an environment of rapid change; work effectively within cross-functional teams; will have a passion for highly innovative therapies that can dramatically improve patients’ lives.
• Regulatory Affairs Sr Manager will be responsible to prepare/execute the development of comprehensive plans for preparation and submission of regulatory submissions. Provides independent tactical/scientifically related guidance cross functionally on aspects of regulatory affairs. Uses knowledge and experience in the regulatory field to influence functional objectives.
• Regulatory Affairs Sr Manager will be responsible to develop and implement SOPs in Argentina (South Cone - Chile, Uruguay, Paraguay -, review, approve and monitor all GxP related activities and ensure proper training for the 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.

• He/she will take an active part of building the QMS and procedures to cover the relevant GxP activities in the territory. Will be in charge of developing, leading and managing all regulatory activities. S/He will also oversee all discussions and negotiations with local vendors and the health care authorities.
• The successful candidate will have the ability to thrive in an environment of rapid change; work effectively within cross-functional teams; will have a passion for highly innovative therapies that can dramatically improve patients’ lives.
• Regulatory Affairs Sr Manager will be responsible to prepare/execute the development of comprehensive plans for preparation and submission of regulatory submissions. Provides independent tactical/scientifically related guidance cross functionally on aspects of regulatory affairs. Uses knowledge and experience in the regulatory field to influence functional objectives.
• Regulatory Affairs Sr Manager will be responsible to develop and implement SOPs in Argentina (South Cone - Chile, Uruguay, Paraguay -, review, approve and monitor all GxP related activities and ensure proper training for the 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