Regulatory Affairs Pharmacist

Description: We at Janssen are looking for an Appointed Pharmacist for our RA department.

Activities and Responsibilities

• Submissions of new drug applications/additional indications/dosage regimen changes of a pharmaceutical product to the Control and Standards of Medicine product Institute and/or Medicine Registration of the Ministry of Health. The appointed pharmacist will make sure the application is in accordance with all regulations and guidelines of the Israeli Ministry of Health as for the structure and content and in alignment with company SOPs/WIs.
• Maintenance of registered Rx products lifecycles
  
  

2.1. Submissions of renewal applications of a pharmaceutical product to the Control and Standards of Medicine product Institute and Medicine Registration of the Ministry of Health. The appointed pharmacist will make sure the application is in accordance with all regulations and guidelines of the Israeli Ministry of Health as for the structure and content and in alignment with company SOPs/WIs.

2.2. Submissions of CMC variations applications of a pharmaceutical product to the Control and Standards of Medicine product Institute and Medicine Registration of the Ministry of Health. The appointed pharmacist will make sure the application is in accordance with all regulations and guidelines of the Israeli Ministry of Health as for the structure and content and in alignment with company SOPs/WIs.

2.3. Submissions of temporary or permanent marketing cessation applications of a pharmaceutical product versus the Israeli Ministry of Health. The appointed pharmacist will make sure the application is in accordance with all regulations and guidelines of the Israeli Ministry of Health as for the structure and content and in alignment with company SOPs/WIs.

2.4. Review and submission of HCP, Patients and public materials including submission of requests for raising illness awareness Campaign, materials for assuring patients treatment adherence, PSP materials etc. The appointed pharmacist will make sure the materials are in accordance with all regulations and guidelines of the Israeli Ministry of Health as for the structure and content and in alignment with company SOPs/WIs.

2.5. Submission of updates to label (physician information / patient leaflets) and assure on-time implementation. The appointed pharmacist will make sure the materials are in accordance with all regulations and guidelines of the Israeli Ministry of Health as for the structure and content and in alignment with company SOPs/WIs.

2.6. Submission of updates to artwork (carton, label, blister, leaflet etc) and assure on-time implementation. The appointed pharmacist will make sure the materials are in accordance with all regulations and guidelines of the Israeli Ministry of Health as for the structure and content and in alignment with company SOPs/WIs.

2.7. Provide cross functional functions with the most up-to-date product registration documentation and approved packaging materials according to company SOPs/WIs.

• Provide support with National Health Basket list (reimbursement) as necessary.
• Being main point of contact versus the Israeli MOH, cross functional contacts locally and globally, vendors etc. Providing answers to any questions raised relating products in scope.
• Coordination of different global regulatory data systems and databases.
• Management of registered Rx products lifecycles in Palestinian Authority, providing regulatory data and support as needed.
  
  

Qualifications:

• B.Pharm Degree – mandatory
• Previous experience in a Global Pharma company as a regulatory pharmacist – a must
• Experience as an Appointed Pharmacist – an advantage
• Strong organizational, project management, and problem-solving skills with exceptional multi-tasking abilities.
• Experience in working in a computer-literate environment, using Microsoft Office – a must, and other computer systems.
• Ability to learn new processes and applications “on-the-fly”.
• Good organizational and project planning skills.