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Required Regulatory Affairs Appointed Pharmacist, Israel
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 our 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 our 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.

Required QPPV, Israel
The QPPV is a senior position within the pharmacovigilance team, responsible for ensuring that we comply with all regulatory requirements related to the safety of its medicinal products. The QPPV is the primary point of contact for the Israeli MoH and our global partners and ensures that we meet our legal obligations regarding the monitoring, assessment, and reporting of adverse drug reactions
Responsibilities
Communicating with the Ministry of Health regarding pharmacovigilance activities, ensuring compliance with local regulations. This includes timely submission of safety reports and responding to inquiries and requests
Overseeing the internal PV system, ensuring its effectiveness and continuous improvement, including processes, tools, and personnel
Managing the safety agreements with our global partners and external suppliers, if applicable
leading PV audits conducted by our global partners and inspections conducted by the Ministry of Health
Communicating with our global partners, including participation in periodic meetings, as required
Monitoring the compliance of our employees with internal procedures, including corrective actions as needed
Collaborating with internal departments such as Regulatory Affairs and Medical Affairs to address pharmacovigilance issues
Ensuring coordination with the Quality Assurance team to ensure pharmacovigilance processes align with company standards
Additional tasks as defined by the manager.