Medison offers hope to patients suffering from rare and severe diseases by forming partnerships with emerging biotech companies to accelerate access to highly innovative therapies in international markets. As the creator and leader of the global partnership category in the pharma industry, we strive to be Always Ahead and work relentlessly to bring therapy to patients in need, no matter where they live. Our values are at the core of every action we take, and we are committed to going above and beyond for the benefit of the patients we serve. We are a dynamic, fast-paced company operating in over 30 countries on 5 continents. We are looking for out-of-the-box thinkers, people who are passionate, caring, agile, and adaptive, to join us on our mission. If you want to make a difference in people's lives, we invite you to join us! The Regulatory Affairs Appointed Pharmacist will supports all Regulatory Affairs activities, including but not limited to preparation of registration dossiers, ensuring compliance with regulatory requirements, drafting product documentation, developing patient leaflets, overseeing packaging design, and managing updates to product labeling.
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
Requirements: * 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
This position is open to all candidates.