Regulatory Affairs Intern // 2021 Internship Program
AstraZenecaPoland - warsawUpdate time: April 7,2021
Job Description

Regulatory Affairs Intern // 2021 Internship Program

 2021 Internship Program at AstraZeneca 

Join a vibrant and dynamic team with the passion and drive to push the boundaries of science! 

 

At AstraZeneca Poland we have a truly collaborative culture and way of working – supportive, open minded and eager to share knowledge. Our Warsaw site is an active and open community where you can collaborate on multiple projects, and find opportunities to further ‘What science can do’.  The Internship Program at AstraZeneca is aimed at graduates and students of the last years of universities who want to use the knowledge gained during their studies in practice. This is an opportunity to raise your professional qualifications in one of the most innovative global biotechnology companies.  By joining AstraZeneca, you will have the opportunity to work with people who have an impact on the lives and health of millions of patients around the world, developing breakthrough therapies that push the boundaries of science. 

As a part of AstraZeneca, Regulatory Affairs team is responsible for licence to operate assurance for our innovative products. Team perform regulatory activities for defined part of AstraZeneca portfolio and drive projects related with among others Regulatory Excellence and quality assurance. The main focus is the maintenance of marketing authorizations for already registered products, preparation of product information (SmPC, PIL), the creation of relations and contacts with the Registration Office (URPL) and preparation of packaging materials for production.

General hiring requirements

Position is an office-based role within Medical Department/Regulatory Affairs team, that works closely with both global AstraZeneca teams and locally within cross-functional teams with individuals from Medical, Distribution/Supply chain, Market Access and Marketing departments. •

  • Supports Regulatory Team during activities related to the registration and maintenance of products in compliance with all local and global AZ standards and procedures including Regulatory Variations and Licence Maintenance Activities
  • Assists with regulatory file compilation and submissions, regulatory approval and maintenance procedures including maintenance of regulatory databases, and websites
  • Performs submission compilation, publishing and approval of product information processes and tools under supervision of experienced Regulatory staff
  • Maintains regulatory/technical archive of product and tracking of submission/achievements being able to satisfy the requirements of any audit or inspection
  • Support in preparation of Short Product Information for promotional purpose based on appropriate SmPC
  • Supports the Regulatory Team and Head of Regulatory Affairs in all activities related to KPI monitoring and control as well as in collecting data for local reports and reviews.

Required skills, candidate background

  • Undertaking graduate studies /completed studies in Life-Sciences in general, Pharmacy, Medicine, Biomedical Sciences, Biotehchnology, Biology, Biochemistry, Vaccine Biotechnology or similar.

 

Posting is closing at………..All submitted applications will be verified by us and assessed based on the objective criteria. Selected candidates will receive an invitation to introduce and present themselves using HireVue - a tool that allows to send answers to recruitment questions in the form of video recordings. On the final stage of the process you will remotely meet the recruiting team consisting of representatives of a given department. At the beginning of June, we will announce a list of people for whom this year's internship program recruitment process was successful. 

The internships will start in July and will last from 3 to 6 months, depending on the department. Initial training (onboarding) and all internships, for safety reasons, are designed fully in the remote formula. 

In this year's internship program we will invite over 50 people to participate!  

Don’t miss your opportunity! We are waiting for you! 

 

AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.

Date Posted

07-kwi-2021

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.

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