Responsibilities:
* Provide professional regulatory advice to Medison’s business units and partners.
* Planning and executing regulatory activities, periodic updates of approved dossiers and managing the change control process for pharmaceutical products.
* Good relationships with regulatory authorities and Medison’s partners and advancing timelines in the registration processes.
* Preparing registration dossiers, including content verification according to SOPs, submission, and tracking of registration dossiers with the Ministry of Health.
* Preparing packaging materials, including review and submission in accordance with the Ministry of Health requirements and in compliance with the product's registration
* conditions.
* Handling all types of submissions, new products, changes, and renewals.
* Ensuring that publications intended for the medical staff comply with Ministry of Health requirements and adhere to the product's registration conditions.
* Preparing registration dossiers for medical devices, including submitting registration applications, renewing licenses according to SOPs, and supporting the company's
* medical equipment and devices unit with registration requirements.
City:
Petah Tikva
* Bachelor’s degree in Pharmacy and a valid Ministry of Health (MOH) license.
* At least 3 years of proven experience as an appointed pharmacist, with in-depth knowledge of regulatory requirements, pharmaceutical operations, and QA.
* Demonstrated ability to work effectively with multiple internal and external interfaces, including commercial, supply chain, medical, and external stakeholders such as health authorities and manufacturers
* Strong understanding of business processes with the ability to align regulatory and pharmaceutical activities with organizational goals, demonstrating strategic thinking and decision-making capabilities.
* Solid knowledge of local and international pharmaceutical regulations, with the ability to ensure compliance and manage audits and inspections.
* Excellent verbal and written communication skills in both Hebrew and English, with the ability to clearly convey complex information and influence stakeholders at all levels.
* Strong analytical mindset with the ability to identify risks, evaluate solutions, and implement effective corrective actions.
* Ability to manage multiple tasks, prioritize effectively, and meet deadlines in a dynamic environment
