AstraZeneca Pharmaceuticals LP Associate Director Regulatory Information Team in Gothenburg, Sweden
At AstraZeneca, we’re not afraid to do things differently. We’re building a new kind of organisation to reset expectations of what a bio-pharmaceutical company can be. This means we’re opening up new ways to work, pioneering cutting edge methods and bringing unexpected teams together.
Regulatory Affairs is part of Global Medicines Development (GMD) which drives late-stage development of our innovative pipeline, transforming exciting science into valued new medicines and ensuring patients around the world can access them.
We provide strategic regulatory expertise and oversight to support the Research, Development and Commercialisation of products for the disease area or stages of development within the TA portfolio across both small molecules and biologics and ensure adequate regulatory resource and skills for projects in line with designated disease area portfolio.
The Regulatory InformationTeam is a part of Global Regulatory Affairs that works with bringing together technology, processes and resources to enable AstraZeneca’s regulatory strategy.
We maintain Regulatory Information in line with legal requirements and company objectives and oversee Regulatory systems, business processes and compliant usage to ensure that the objectives of the regulatory information are met.
The RIM team partners with individual system and information owners within Regulatory to ensure the overall strategy for RIM. Another important task is partnering with our IT organization and other Business functions as well as with vendors to influence health authority and industry innovation.
There is an extensive collaboration with all business units creating regulatory information across the entire value chain, from development through marketing, maintenance and pharmacovigilance.
We are now looking for an Associate Director to join our team in Gothenburg, Sweden or Gaithersburg, US.
As an Associate Director of the Regulatory Information Team you will be maintaining and developing regulatory information management (RIM) within AstraZeneca.
You enable and drive efficient management of the regulatory information with regards to our licenses and submissions worldwide and oversee regulatory information quality and reporting. You work with strategy implementation to ensure oversight of system compliance, business value and efficiency in the management and delivery of regulatory information.
Other important responsibilities are to lead change projects and continuous improvements activities
as well as ensuring that the regulatory information is communicated and understood by broader cross functional teams.
So, are you excited about big data analytics? Do you want to be influence the information flow and be the bridge between business and IT? Then you might be what we are looking for!
5+ years of any authority related business
Strong process mapping and authoring skills
Experience in implementing regulatory systems
Experience in Regulatory information management/GxP data
Experience in XEVMPD/ISO IDMP
Strong Stakeholder Management skills
Experience in project management, managing project timelines and resources
Detail focused and the ability to manage complex, multiple projects
Experience with working in high pressure environments and teams where sensitivity to priorities needs to be handled whilst still delivering against strategic objectives
Excellent analytical skills
Strong social skills with the ability to collaborate with people on different levels, in sometimes sensitive areas.
If you are interested, apply now!
For more information about the position, please contact Linda Marie Jansson at Linda-Marie.M.Jansson@astrazeneca.com
Or why not visit our websites:
Gothenburg site: https://www.astrazeneca.com/our-science/gothenburg.html
Gaithersburg site: https://www.astrazeneca.com/our-science/gaithersburg.html
Welcome with your application no later than April 8, 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.