Non-clinical Submission Manager

Join our Biopharmaceuticals R&D team as a NonclinicalSubmission Manager. In this role you will collaborate with AstraZeneca nonclinicalscientists and Regulatory colleagues to manage the planning preparation and finalization of all nonclinical contributions includingSEND datasets to regulatorysubmissions throughout the productlifecycle. This role requires efficiency results orientation and effective communicationskills as you will be managing a portfolio of projects to agreed targets and qualitystandards often working to tight timelines.

Accountabilities:

As a NonclinicalSubmission Manager your responsibilities will include project managing the nonclinical contributions ofsubmissions from first timeinhuman through to marketing applications. You will work in matrix management with toxicologistssubject matter experts and regulatorysubmission teams. You will represent nonclinicalsubmissions on global regulatorysubmission teams and ensuresubmission timelines and qualitystandards are maintained. Your role will also involve prioritizing activities and adjusting to meet dynamic timelines while communicating crossfunctionally.

EssentialSkills/Experience:

BSc or MSc or equivalent inscientific discipline related to drug or biologics development

Pharmaceutical industry experience with anunderstanding of pharmacological toxicological and pharmacokinetic principles and their application in regulatorysubmissions

Proven project managementskills

Motivatedselfstarter comfortable working on multiple projects in parallel

Highly developed influencingskills and interactive communication when interacting with people at alllevels and within teams

Demonstrated ability toset and manage priorities resources goals and project timelines

Excellentscientific writingskills; regulatory writing background preferred

Familiarity with regulatory documentation managementsystems eg Veeva Vault

Knowledge of FDA and EMEA regulatory requirements ICH guidelines and their application

Ability to communicate effectively (written and spoken) in English

DesirableSkills/Experience:

Experience working in crossfunctional global project teams

RACDrugs certification

When we put unexpected teams in the same room we unleash bold thinking with the power to inspire lifechanging medicines. Inperson working gives us the platform we need to connect work at pace and challenge perceptions. Thats why we work on average a minimum of three days per week from the office. But that doesnt mean were not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

Why AstraZeneca

At AstraZenecasBiopharmaceuticals R&D we are part of thesolution turning our drug developmentstrategies into reality. We work at allstages of development to translate ourlifechangingscience into medicines to get the best results for AstraZeneca patients in need and healthcare professionals. We are a diverse and openminded team harnessing our differentskills and experiences. Our differences enableus to explore new ideas and ways of doing things. It keepsus on our toes and excited for whatsnext.

Ready to make a difference Apply today and be part of our journey to createlifechanging medicines!

Please apply with an English Resume