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!

Date Posted

Closing Date

AstraZeneca embraces diversity and equality of opportunity.  We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.  We believe that the more inclusive we are, the better our work will be.  We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.  We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.