Position Overview

The Appointed Pharmacist is responsible for managing regulatory activities related to pharmaceutical products in Israel, ensuring compliance with Ministry of Health (MOH) regulations and alignment with global and local company standards. The role supports the full product lifecycle—from new drug applications to post‑approval maintenance—while collaborating closely with cross‑functional local and global teams.

The position plays a critical role in advancing regulatory approvals, maintaining regulatory competitiveness, and supporting business objectives through timely, compliant submissions.

Key Responsibilities

1. Regulatory Submissions – New Products and Changes

• Prepare and submit:
  • New Drug Applications (NDAs)
  • Additional indications
  • Dosage regimen changes
    to the Control and Standards of Medicine Institute and/or the Medicine Registration Department of the Israeli Ministry of Health.
• Ensure all submissions comply with Israeli MOH regulations, guidelines, and company global/local standards (SOPs/WIs).
• Drive regulatory competitiveness while challenging and accelerating submission timelines wherever possible.

2. Lifecycle Management of Registered Rx Products

• Renewals

  • Prepare and submit renewal applications in compliance with MOH regulations and company standards.

• CMC Variations

  • Prepare and submit CMC variation applications, ensuring regulatory compliance and alignment with internal procedures.

• Marketing Cessation

  • Prepare and submit temporary or permanent marketing cessation applications to the Israeli MOH.

• Promotional & Educational Materials

  • Review and submit materials intended for HCPs, patients, and the general public, including:
    • Disease awareness campaigns
    • Patient support programs (PSPs)
    • Treatment adherence materials
  • Ensure full compliance with MOH requirements and internal SOPs/WIs.

• Labeling Updates

  • Prepare and submit updates to:
    • Physician Information (PI)
    • Patient Information Leaflets (PILs)
  • Ensure on‑time implementation.

• Artwork Updates

  • Manage submissions and implementation of updated artwork (cartons, labels, blisters, leaflets, etc.).

• Cross‑Functional Collaboration

  • Foster effective collaboration with local and global cross‑functional teams to support strategic company objectives.

3. Reimbursement Support

• Provide regulatory support as required for National Health Basket (reimbursement) submissions.

4. Regulatory Liaison

• Serve as the primary point of contact with:
  • Israeli Ministry of Health
  • External vendors and partners
• Lead and facilitate regulatory approval processes and respond to MOH inquiries related to products in scope.

5. Regulatory Excellence & Compliance

• Drive continuous improvement in regulatory compliance standards.
• Coordinate and maintain global and local regulatory data systems and databases.

6. Palestinian National Authority (PNA) Regulatory Support

• Support regulatory submissions for:
  • New drug applications
  • Additional indications
  • Dosage regimen changes
• Manage lifecycle activities of registered Rx products in the Palestinian Authority, providing regulatory data and support as required.

Minimum Qualifications

• B.Pharm degree – mandatory
• Previous relevant experience in Regulatory Affairs, preferably in a global pharmaceutical company.
• Strong customer‑focused mindset with awareness of business results.
• Ability to operate effectively in complex, fast‑changing environments.
• Full adherence to:
  • International Health Care Business Integrity Guide
  • Local regulations and Codes of Conduct
  • Company Credo Values

Additional Requirements & Skills

• Strong teamwork and cross‑functional collaboration skills.
• Excellent organizational, planning, and prioritization abilities.
• Strategic mindset with the ability to understand long‑term business goals.
• Agile thinking and strong execution capabilities.
• Proven project management and problem‑solving skills with outstanding multi‑tasking ability.
• High level of computer literacy:
  • Microsoft Office – mandatory
  • Excel – mandatory
• Ability to quickly learn new systems, processes, and applications.
• Strong motivation for networking and relationship building with internal and external stakeholders.

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