Dossier Manager - Global Regulatory Operations

AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialization 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. At AstraZeneca, we’re proud to have a unique workplace culture that inspires innovation and collaboration. Here, employees are empowered to express diverse perspectives – and are made to feel valued, energized and rewarded for their ideas and creativity.

Are you a relationship builder with passion for regulatory affairs? Do you enjoy working in global cross functional project teams? If yes - then this might be something for you!

Om tjänsten
As a Dossier Manager you provide an Global Regulatory Operation (GRO) interface to Regulatory partners, and your responsibility is to support and navigate submission projects to regional partners and Health Authorities and update Lifecycle Management system for defined products.


Dina arbetsuppgifter i huvudsak
Your direct responsibilities:
• Collaborate and serve as a navigator for the Regulatory Project Teams, regards to the operational aspects of Publishing, Submission and Tracking of Regulatory submissions
• Develop and maintain strong partnerships with local and global customers and partners
• Acting as the first point of contact to the expertise within GRO regards to Document publishing, Submission Publishing and Submission Tracking
• Update Lifecycle Management system for defined products
• Support Lifecycle Management reports to support lifecycle compliance

Vem är du?
Essential Requirements
• University Degree in Science or related experience
• Proven leadership skills of global cross functional project teams
• Relevant experience of working in one or more areas in Regulatory Affairs in the pharmaceutical or related industry
• Fluent in English, written and spoken

Desirable Requirements
• Experience of working with Regulatory document or submission publishing, understanding the different procedures, formats and market requirements
• Planning for and managing submission publishing activities

Om verksamheten
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 or any other characteristic protected by law.

This is a consultant assignment at AstraZeneca for 12 monthts time and with possibilities of extension. During the period of the assignment you will be employed by Poolia.

Submit your application today! If you have any questions regarding the consultant assignment feel free to contact Robin Öz.