Detail

Salary
negotiable
Location
Cambridge, UK
Posted by: Astra Zeneca
29 Oct
86 Views
28 Dec expires

Associate Regulatory Affairs Director - Oncology

Cambridge, UK
Job Description

Within Oncology Regulatory Affairs, we work in areas of unmet needs and take innovative regulatory approaches to bring life-changing treatments to those who need it – working across our pipeline and the business to get medicines to patients as efficiently and effectively as possible. As an industry leading Oncology Regulatory function, we’re growing fast and we’re as focused and committed to the development of our people as we are our business – providing an open and supportive space to explore, learn, grow and develop across all roles and levels.

 

As an Associate Regulatory Affairs Director in Cambridge, UK working within Oncology Regulatory Science and Strategy, you’ll play a pivotal role in channelling our scientific capabilities to make a positive impact on changing patients’ lives.

                    

Description:

 

The Associate Regulatory Affairs Director (ARAD) is an experienced regulatory specialist with strong project management capabilities responsible for leading the end-to-end planning, coordination, and execution of assigned deliverables. The ARPD is a key contributor to regulatory submission strategy, identifying submission risks and opportunities, while leading regulatory applications and managing procedures through approval. The ARPD provides regulatory expertise and guidance on procedural and documentation requirements to Global Regulatory Execution Team (GRET), Global Regulatory Strategy Team (GRST) and cross-functional teams working flexibly within and across regions to ensure the delivery of business objectives.



Job ID Reference
1534
Desired Skills & Experience

Minimum Requirements – Education and Experience:

  • BS/MS Degree in Science or related discipline
  • Extensive regulatory experience within the biopharmaceutical industry, or experience at a health authority.
  • Thorough Knowledge of drug development
  • Strong project management skills
  • Leadership skills, including experience leading multi-disciplinary project teams

 

Preferred Experience:

  • Managed first wave Marketing Application and/or LCM submissions
  • Managed complex regulatory deliverables across projects/products
  • Knowledge of AZ Business and processes
Company
  Gaithersburg, Maryland, USA
  www.astrazeneca.com
AstraZeneca is an exciting global, innovation-driven biopharmaceutical company. We’re inspired by what science can do. Driven by the desire to meet unmet patient needs in our core therapeutic areas. Bold in our thinking. Proactive in pursuing discoveries beyond imagination. At sites across the world, we bring teams together in a spirit of collaboration to turn great ideas into life-changing medicines – strengthening our product portfolio and harnessing the potential of a pipeline across all stages of the drug development process.
You’ll be part of a team that’s rolling back the frontiers of science to turn yesterday’s impossible into the normal of tomorrow. So, if you share our focus and passion, join us and make a difference to patients – and in return, we’ll help you develop way beyond what you thought possible.
  Workplace
 Cambridge, UK