Appointed Pharmacist

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 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.comJob Function:Regulatory Affairs GroupJob Sub Function:Regulatory AffairsJob Category:ProfessionalAll Job Posting Locations:Kibbutz Shefayim, Center District, IsraelJob Description:Position OverviewThe 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 Responsibilities1. Regulatory Submissions – New Products and ChangesPrepare and submit:New Drug Applications (NDAs)Additional indicationsDosage regimen changesto 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 ProductsRenewalsPrepare and submit renewal applications in compliance with MOH regulations and company standards.CMC VariationsPrepare and submit CMC variation applications, ensuring regulatory compliance and alignment with internal procedures.Marketing CessationPrepare and submit temporary or permanent marketing cessation applications to the Israeli MOH.Promotional & Educational MaterialsReview and submit materials intended for HCPs, patients, and the general public, including:Disease awareness campaignsPatient support programs (PSPs)Treatment adherence materialsEnsure full compliance with MOH requirements and internal SOPs/WIs.Labeling UpdatesPrepare and submit updates to:Physician Information (PI)Patient Information Leaflets (PILs)Ensure on‑time implementation.Artwork UpdatesManage submissions and implementation of updated artwork (cartons, labels, blisters, leaflets, etc.).Cross‑Functional CollaborationFoster effective collaboration with local and global cross‑functional teams to support strategic company objectives.3. Reimbursement SupportProvide regulatory support as required for National Health Basket (reimbursement) submissions.4. Regulatory LiaisonServe as the primary point of contact with:Israeli Ministry of HealthExternal vendors and partnersLead and facilitate regulatory approval processes and respond to MOH inquiries related to products in scope.5. Regulatory Excellence & ComplianceDrive continuous improvement in regulatory compliance standards.Coordinate and maintain global and local regulatory data systems and databases.6. Palestinian National Authority (PNA) Regulatory SupportSupport regulatory submissions for:New drug applicationsAdditional indicationsDosage regimen changesManage lifecycle activities of registered Rx products in the Palestinian Authority, providing regulatory data and support as required.Minimum QualificationsB.Pharm degree – mandatoryPrevious 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 GuideLocal regulations and Codes of ConductCompany Credo ValuesAdditional Requirements & SkillsStrong 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 – mandatoryExcel – mandatoryAbility to quickly learn new systems, processes, and applications.Strong motivation for networking and relationship building with internal and external stakeholders.#LI-LM5Required Skills:Preferred Skills:Analytical Reasoning, Business Writing, Coaching, Collaborating, Communication, Legal Support, Problem Solving, Product Licensing, Public Policies, Regulatory Affairs Management, Regulatory Compliance, Regulatory Development, Regulatory Environment, Regulatory Reporting, Risk Assessments, Strategic Thinking