Labelling and Administration Officer

JOB TITLE
Regulatory Affairs: Labelling & Administration Officer

ABOUT ASTRAZENECA
AstraZeneca is a global, science-led, patient-focused biopharmaceutical
company that focuses on the discovery, development, and commercialisation of
prescription medicines for some of the world 's most serious diseases. But
we're more than one of the world's leading pharmaceutical companies.
ROLE SUMMARY
Local Documents preparation, Data management, Archiving and labelling function
is a requirement to support Regulatory Affairs. This role is responsible for
the entire regulatory and Scientific office data, document infrastructure and
managing the related labelling for AZ portfolio.
What you 'll do
* Carries out administrative duties related to the regulatory activities such as filing, typing, copying, binding, archiving, scanning etc.
* Maintenance and development of department administrative and information procedures including and Regulatory Affairs systems
* Contributes to team effort by accomplishing related results as needed
* Create product labels and maintain databases of labels, a strong attention to detail and efficiency in proofreading, data entry, and database management is essential.
* Co-ordination, initiation, and finalization of labels / cartons / package insert text matter as per the requirements
* Maintain contacts with all stakeholder e.g., packaging sites, Regulatory Affairs, Supply Chain Dept and external artwork Vendors.
* Responsible for the correct and timely control of the art-work design department (internal and/or external)
* Collecting all necessary information for the preparation of new product labelling, such as technical specifications, design specifications, registration requirements and texts.
* Responsible for correct/complete intake of the documents and procedure that trigger initiation of introductions / changes.
* Assist in coordinating effectively & efficiently Admin activities, including. Creating, updating, and maintaining records and databases related to Regulatory activities.
* Supporting department managers to provide all local documents needed for their submissions.
* Responsible for the archiving of all prepared or received documents from Regulatory Affairs Colleagues or other related Authorities.
Essential for the role
* Saudi National
* Bachelor 's degree is required
* ‎1 to ‎3 years of relevant experience (Regulatory Affairs - Labelling) for external candidates.
* Gained work experience in pharmaceutical Multinational Companies.
Technical Skills, Qualifications & Experience:
* Well-developed IT skills, including good use of standard software packages (MS SharePoint, Word, Excel, PowerPoint, Outlook and Adobe Acrobat).
Stakeholder Oriented:
* Strong focus on the delivery of excellent customer service, including expectation management.
* Evidence of ability to cultivate and manage relationships successfully with colleagues, stakeholders, suppliers and collaborators, with a people-centred approach to business and work essential.
* Ability to gain credibility with, and the respect of, staff at all levels of the AZ.
Organisational:
* Excellent organisational and administrative skills.
* Ability to work well under pressure and to prioritise work effectively.
* Ability to manage time, and prioritise urgent and essential tasks, to ensure tight deadlines are met.
* Evidence of ability to operate and get results in a very busy environment with several tasks competing for priority.
Communications:
* Fluency in English and Arabic spoken and written, is essential.
* Some experience of preparing and delivering presentations and reports would be an advantage
Personal attributes:
* Excellent attention to detail, balanced with an ability to get things done efficiently.
* Proactive and enjoys taking on responsibility, with a patient and positive attitude.
* High levels of probity and discretion.
* A problem solver and team player, with the ability to work independently but recognise when to ask for support.
* Confident, with ability to develop effective working relationships with people at all levels within the AZ, and its external stakeholders.
* Willingness and enthusiasm to contribute to MSC-wide responsibilities and development, when appropriate, in pursuit of the AZ's mission and vision.
* Empathy and interest in the AZ's mission and objectives. Cross functional engagement
* Business Acumen
* Impact and Influence
* Decision making and problem solving
Why AstraZeneca?
At AstraZeneca we 're dedicated to being a Great Place to Work. Where you are
empowered to push the boundaries of science and unleash your entrepreneurial
spirit. There's no better place to make a difference to medicine, patients,
and society. An inclusive culture that champions diversity and collaboration,
and always committed to lifelong learning, growth, and development. We're on
an exciting journey to pioneer the future of healthcare.

So, what 's next?
* Are you already imagining yourself joining our team? Good, because we can't wait to hear from you.
* Are you ready to bring new ideas and fresh thinking to the table? Brilliant! We have one seat available, and we hope it's yours.
Where can I find out more?
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