The team is involved in developing regulatory product strategies, leading regulatory efforts in the development stage and post marketing of drug products in the Israeli market.
Main responsibilities:
Serve as Appointed Pharmacist, responsible for all matters related to medical products as specified by the Ministry of Health
Ensure compliance with local Israeli regulations and requirements
Manage regulatory aspects of product lifecycle from development through post-marketing including:
– Define registration and maintenance plans
– Coordinate country dossier preparations
– Manage registration, renewal, and post-authorization variation processes
– Update product labels and packaging materials
– Contributing to the Global Regulatory Product Strategy
Review promotional and non-promotional materials for regulatory compliance
Implement processes and quality systems
Monitor changes in the regulatory environment in Israel
Build strong external network with Health Authorities and Trade Associations
Experience:
Minimum 3 years of industry experience in regulatory affairs
Regulatory strategy development and implementation
Experience with Israeli Ministry of Health submissions
Experience with post-approval regulatory activities and lifecycle management
Soft and technical skills:
Knowledge of local and global pharmaceutical regulations and requirements, Health related regulations (i.e., ICH, FDA, EU, Israeli Ministry of Health)
Strong coordination and leadership abilities
Excellent negotiation and communication skills
Ability to manage large workload under pressure and meet tight deadlines
Proficiency in electronic document management systems (e.g., Veeva vault, Plai)
Detail-oriented with strong organizational skills
Ability to adapt rapidly to different products and regulatory environments
Education:
Bachelor in Pharmacy degree required
Master of Science preferred
Languages:
Fluent in Hebrew and English
