Regulatory Ass. Pharmacist

Job Description

At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being results-oriented thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you’re our kind of person.

AstraZeneca’s pipeline of innovative medicines is consistently growing within both Cardiovascular, Renal and Metabolism (CVRM) and Respiratory and Immunology (R&I) two of our major therapy areas. To meet the increasing demand of regulatory expertise, we continue to expand our regulatory functions. With us, you will get the opportunity to work across the spectrum of drug development to progress a rich and diverse pipeline of both small and big molecules. You will work across multiple therapy areas in an atmosphere of collaboration and inclusion where Regulatory Affairs is a respected voice and considered an equal partner in the business.

• Product registration & maintenance

Preparation of registration files, with the support and supervision of the appointed pharmacists. In the content and structure of the CTD according to the requirements of the ICH, and in accordance with the regulatory requirements of the Israeli Ministry of Health, and in accordance with the policies and procedures of AstraZeneca.

• Preparation of packaging materials of the company's preparations.

Registration

• Preparation of registration files in all areas of registration (new registrations, innovations, clinical changes and change in the quality chapter), leaflet updates and any registration work required according to the instructions of the appointed pharmacists.
• Documentation and follow-up for all registration activities in accordance with the company's requirements,
• Updating 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.

• Handling import permits for registered preparations and raw materials

The work processes will be carried out in accordance with the requirements of the company's quality system and the GRP standard

Preparation of packaging

• Preparation of packaging materials
• Handling and monitoring the preparation of the packaging processes in the company's systems.
• 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 Astraznica Israel procedure.
• Reporting to: Regulatory Head

Education, Qualifications, Skills and Experience

Essential

Pharmacist with a valid Ministry of Health license to practice pharmacy

experience in the field of registration

Good command of spoken and written English

Desirable

Experience in product registration.

Experience in artwork creation (packaging)

Knowledge and experience in QMS

Team Player

Able to handle multiple responsibilities

High ethical standards

Punctual, meticulous

High level of computer knowledge

Proactive in task management

Responsible, accountable

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.

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Where can I find out more?

Please visit us at: https://www.astrazeneca.com/country-sites/israel.html

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