AstraZeneca Pharmaceuticals LP Dossier Manager - Global Regulatory Operations in Gothenburg, Sweden

Location: Gothenburg, Sweden – Gaithersburg, US

Are you our Dossier Manager who would like to take on this unique role with a broad spectrum of responsibilities?

As a Dossier Manager you provide an Global Regulatory Operation (GRO) interface to Regulatory partners, and your responsibility is to define submission publishing lead times, update Lifecycle Management system for Development products and manage the submission projects to regional partners and Health Authorities.

Your direct responsibilities:

  • Collaborate with project teams to assure efficient delivery of submission output and ensuring Service Level Agreement compliance for submission deliverables

  • Develop and maintain strong partnerships with internal and external customers and partners

  • Oversee and manage submission request tool, define and agree submission publishing lead times and determine market submission formats

  • Update Lifecycle Management system for Development products

  • Provide Lifecycle Management reports to support lifecycle compliance

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 formats and market requirements

  • Planning for and managing submission publishing activities

Next Steps – Apply today!

Do you have what it takes? Welcome to join one of the best teams on the planet!

For more information about the position please contact: Niclas Lind at +46 (0)708 467 607.

Welcome with your application no later than 2th of April 2018

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.