Regulatory Associate

Job Title: Regulatory Affairs Associate

Introduction to role

The Regulatory Affairs Associate will play a pivotal role in managing the packaging preparation process, and support registration activities, ensuring compliance with regulatory requirements. This involves supervising the process for all company products to ensure long-term compliance and timely implementation across various functions.

Accountabilities

Preparation of Packaging components for medicinal products

• Handling and monitoring the preparation of the packaging processes in the company's systems.
• Preparation of packaging materials for the company's products using AZ systems
• Translation of the products leaflets using the qualified outsource translator, inclusion of the text into the leaflet layout for the product package. Using GMP standard for the required controls in the process.
• The work will be carried out in accordance with the GMP standard, in accordance with the requirements of the Ministry of Health in Israel - relevant procedures, the company's quality standards and the AstraZeneca Israel procedure.
  
  

Registration

• Preparation of labelling update prior to submission to the Ministry of Health.
• Follow up activities after leaflet approval, publishing, and system updates.
• Preparation of registration files in all areas of registration; new drug applications, clinical changes and change to the quality chapter, CMC changes, leaflet updates and any regulatory activity as required according to the local regulations and AstraZeneca policies and guidelines.
• Documentation and follow-up for all registration activities in accordance with the company's requirements.
• Update of registration data in the company's local and global systems
• Update the actions required after receiving approval from the Ministry of Health for new submissions and quality changes.
• The work processes will be carried out in accordance with the requirements of the company's quality system and the GRP standard
• Carry out the procurement using SAP system and the required administrative support.
• Management of quality system as a basis of the working standard, including of carry out of self-assessment as per annual plan.
  
  

Essential Requirements

• Bachelor's degree natural science
• Good command of spoken and written English
• Accurate and result oriented, Punctual, meticulous
• Ability to work under pressure without compromising on results
• High ethical standards
• High command of the English language – spoken & written
• High level of computer knowledge
• Proactive in task management
• Responsible, accountable
• Able to handle multiple responsibilities
• High performer and results oriented with proven results
• Team player
• Good communication & ability to collaborate effectively across functions
  
  

Desirable

• Experience in translations artwork creation (packaging) , product registration
• Knowledge and experience in Managing Quality System is a preference
  
  

At AstraZeneca, we take pride in being the voice of the patient. Our commitment to quality ensures that every batch we certify is a personal stamp of approval. We are constantly innovating, trialling the latest models and technologies to improve reliability and excellence in our processes. Here, you will feel empowered to step up, follow the science, and make decisions that put patients first. Our collaborative environment fosters strong communication and teamwork, allowing us to deliver our pipeline sustainably, reliably, and safely. Join us in making a real-life difference to patients' healthcare and quality of life.

Ready to make an impact? Apply now!