Nonclinical Submission Manager

Prepares/executes global/regional nonclinical regulatory submissions on allocated projects/products that implement the agreed regulatory strategy to develop and maintain products. Generates/project manages delivery, to time/quality of submissions. Demonstrates in depth knowledge of Regulatory compliance and submissions. Develops and builds good relationships with internal customers and Regulatory authorities, improving Regulatory outcomes.

Here you’ll have the opportunity to make a meaningful difference to patients’ lives. With science at its heart, this is the place where breakthroughs born in the lab become transformative medicines – for the world’s most complex diseases. Answer unmet medical needs by pioneering the next wave of science, focusing on outcomes and shaping the patient ecosystem. 

Seamlessly come together in our inclusive environment. Here all doors are open, and every voice is heard. From working side-by-side with academia to innovating with biotech – we are forever expanding our horizons.

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 in Cambridge, 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.

What you’ll do

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.

You are

• BSc or MSc or equivalent, in scientific discipline related to drug or biologics development
• 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 Criteria

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

Benefits of Working in ICON:Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs.  In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.