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מודים לך שלקחת חלק בשיפור התוכן שלנו :)
29/05/2025
חברה חסויה
Location: Yakum
Job Type: Full Time
Join us in one of our corporate functions and you can play a vital part in the performance of our entire business while helping to make an impact on millions around the world.

As a Quality Assurance in Israel, you will ensure compliance with global quality standards through documentation management and process control. You will oversee training programs, monitor quality metrics, and manage local GxP subcontractor oversight. You will drive continuous improvement through risk management and quality audits to maintain the highest standards of quality assurance

Main responsibilities:

Support the maintenance of Country Quality documentation management system in compliance with global procedures and quality standards.

Deviation and Corrective-Preventive Actions (CAPA) management: maintain the process to manage deviations and CAPAs related to all GxP and health-regulated activities

Change Control management: maintain the process to manage the changes that may impact GxP or health-regulated process or operations by leading multidisciplinary exchanges and action plans when necessary

Training: organize and manage information sharing, training sessions or programs related to processes owned by the Quality unit for concerned country associates, according to our standards and regulatory requirements

Country Quality Review: Monitor the related Quality Program and Action Plan follow-up

Country Quality performance indicators (KPIs): periodically report country KPIs defined by Global Quality

Support Quality oversight of locally managed GxP subcontractors: ensure an appropriate quality oversight process of locally managed subcontractors

Quality risk management: Ensure that quality risks are properly managed within the country (identification, assessment, control, communication)

Organize and participate in self-inspections, internal audits and external audits of third parties (suppliers / distributors / carriers / etc.) in accordance with the approved annual plan.
Requirements:
Education: University degree (advantage: Quality assurance/ Pharmacy / Chemistry / Medicine)

Experience:

Previous Quality Assurance experience is a plus

Knowledge of pharmaceutical legislation

Knowledge of quality standards

Core Competencies:

Strong knowledge of pharmaceutical legislation, Quality standards

Good understanding of medical, marketing, financial, logistic and legal aspects, as well as their impact on the affiliate business

Strategic view of the pharmaceutical industry

Skills

Capacity to work as part of a team

Very good communication skills

Flexibility in complex and changing environment

Able to take timely and effective decisions using innovation and initiative

Computer literacy

Languages: Fluent in Hebrew and advanced English skills
This position is open to all candidates.
 
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הגשת מועמדותהגש מועמדות
עדכון קורות החיים לפני שליחה
עדכון קורות החיים לפני שליחה
8197811
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שירות זה פתוח ללקוחות VIP בלבד
משרות דומות שיכולות לעניין אותך
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דיווח על תוכן לא הולם או מפלה
מה השם שלך?
תיאור
שליחה
סגור
v נשלח
תודה על שיתוף הפעולה
מודים לך שלקחת חלק בשיפור התוכן שלנו :)
29/05/2025
Location: Yakum
Job Type: Full Time
Join our Israeli Regulatory team as a Regulatory Affairs Manager and Appointed Pharmacist responsible for the registration and maintenance of Marketing Authorizations for medicinal products of assigned portfolio and related health regulated activities. You will be also involved in transversal regulatory activities in dedicated projects.

The team is involved in developing regulatory product strategies, leading regulatory efforts in the development stage and post marketing of drug products in the Israeli market.

Main responsibilities:

Serve as Appointed Pharmacist, responsible for all matters related to medical products as specified by the Ministry of Health
Ensure compliance with local Israeli regulations and requirements
Manage regulatory aspects of product lifecycle from development through post-marketing including:
- Define registration and maintenance plans
- Coordinate country dossier preparations
- Manage registration, renewal, and post-authorization variation processes
- Update product labels and packaging materials
- Contributing to the Global Regulatory Product Strategy
Review promotional and non-promotional materials for regulatory compliance
Implement processes and quality systems
Monitor changes in the regulatory environment in Israel
Build strong external network with Health Authorities and Trade Associations
Requirements:
Experience:

Minimum 3 years of industry experience in regulatory affairs
Regulatory strategy development and implementation
Experience with Israeli Ministry of Health submissions
Experience with post-approval regulatory activities and lifecycle management
Soft and technical skills:

Knowledge of local and global pharmaceutical regulations and requirements, Health related regulations (i.e., ICH, FDA, EU, Israeli Ministry of Health)
Strong coordination and leadership abilities
Excellent negotiation and communication skills
Ability to manage large workload under pressure and meet tight deadlines
Proficiency in electronic document management systems (e.g., Veeva vault, Plai)
Detail-oriented with strong organizational skills
Ability to adapt rapidly to different products and regulatory environments
Education:

Bachelor in Pharmacy degree required
Master of Science preferred
Languages:

Fluent in Hebrew and English
This position is open to all candidates.
 
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הגשת מועמדותהגש מועמדות
עדכון קורות החיים לפני שליחה
עדכון קורות החיים לפני שליחה
8197816
סגור
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