Diverse Minds. Go further with bold new opportunities Collaborate with diverse minds

Collaborate in an inclusive environment, a place full of bold new opportunities. And in return… we’re looking for people who are open and respectful, ambitious and driven.

Who we are

Naturally curious, we are forever connecting and collaborating. Uncovering new insights that equip us to challenge convention and push the boundaries.

How we do it

Committed to living our values – they guide our behaviours, actions and decisions, everyday.

It drives us to work together as one global team to achieve our goals. A supportive place where all are encouraged and achievement is recognised. Strengthening our knowledge through constructive feedback and coaching, as well as collaborating with the best.

Why we love it

This is the place to make an impact. Here we ensure everyone can reach their full potential, perform at their best and make a valued contribution to the enterprise.

As a Nonclinical Submission Manager within the Nonclinical Submissions Group you will play a pivotal role in managing the planning, preparation and finalisation of all nonclinical contributions including SEND datasets to regulatory submissions . 

This is an exciting time to join AstraZeneca. We’re looking for Nonclinical Submission Manager to join our team, where we have invested in a state-of-the-art research centre, and work in an environment where you’ll feel valued, energised and you’ll help drive and shape our function.

Main duties and responsibilities

As a Nonclinical Submission Manager within the Nonclinical Submissions Group you will work with AstraZeneca nonclinical scientists and regulatory colleagues to manage the planning, preparation and finalisation of all nonclinical contributions including SEND datasets to regulatory submissions (primarily FTIH and marketing applications) throughout the product lifecycle. You will be responsible for managing a portfolio of projects to agreed targets and quality standards, so will need to be efficient, results oriented and able to communicate effectively in project teams, working to tight timelines. Organisational and leadership skills are essential as is high quality control.

Essential requirements

• BSc or equivalent, in pharmacology, biochemistry, pharmacokinetics, or toxicology
• Pharmaceutical industry experience with an understanding of pharmacological, toxicological and pharmacokinetic principles and their application in regulatory submissions
• Proven project management skills
• Motivated self-starter comfortable working on multiple projects in parallel
• Highly developed influencing skills and interactive communication when interacting with people at all levels and within teams
• Demonstrated ability to set and manage priorities, resources, goals and project timelines

Desirable requirements

• Experience working in cross-functional, global project teams
• Excellent scientific writing skills; regulatory writing background preferred
• Knowledge of FDA and EMEA regulatory requirements, ICH guidelines and their application

Salary: Competitive

So, what’s next?

Are you already imagining yourself joining us? Good, because we can’t wait to hear from you!

Advertising opens on 31st August 2021 and we welcome with your application; CV and cover letter, no later than 15th September 2021

For more information please contact: alexander.doyle@astrazeneca.com

Additional information

Our Company Values & Behaviors underpin everything we do so please take a moment to familiarize yourself with them. You may also want to check out our new R&D Video showing how we turn Science into Medicines. Covid-19 Resources

More information about our sites:

• Cambridge, UK
• Gothenburg, Sweden
• Gaithersburg, US

Date Posted

Closing Date

AstraZeneca embraces diversity and equality of opportunity.  We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.  We believe that the more inclusive we are, the better our work will be.  We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.  We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.