Appointed Pharmacist Regulatory Affairs

Description:

Johnson & Johnson is currently seeking Appointed Pharmacist Regulatory Affairs to join our TEAM located in Kibbutz Shefayim.

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and where solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity. Learn more at https://www.jnj.com/.

Essential Job Duties 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:
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
  
  

• B.Pharm Degree – mandatory.
• Previous Relevant regulatory affairs work experience (preferably in a Global Pharma company as a regulatory pharmacist).
• Highly customer-focused with an awareness of the importance of Company results.
• Innovative with the ability to coordinate and drive a complex and changing environment.
• Awareness of and adherence to the International Health Care Business Integrity Guide. and related procedures, all local regulations and Codes of Conduct, Janssen Credo Values.
  
  

• Highly experienced and motivated in aspects of teamwork and collaboration.
• Skilled in organizational and planning skills, with the ability to see a wide scope of business and organizational long-term needs and goals.
• Agile and focused thinking and approach.
• 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), Excel - Must, and others.
• Ability to learn new processes and applications “on the fly.”
• Motivated with regards to networking and customer-relations development.