Join our Biopharmaceuticals R&D team as a Nonclinical Submission Manager. In this role, you will collaborate with AstraZeneca nonclinical scientists and Regulatory colleagues to manage the planning, preparation, and finalization of all nonclinical contributions, including SEND datasets to regulatory submissions throughout the product lifecycle. This role requires efficiency, results orientation, and effective communication skills as you will be managing a portfolio of projects to agreed targets and quality standards, often working to tight timelines.
Accountabilities:
As a Nonclinical Submission Manager, your responsibilities will include project managing the nonclinical contributions of submissions from first time-in-human through to marketing applications. You will work in matrix management with toxicologists, subject matter experts, and regulatory submission teams. You will represent nonclinical submissions on global regulatory submission teams and ensure submission timelines and quality standards are maintained. Your role will also involve prioritizing activities and adjusting to meet dynamic timelines while communicating cross-functionally.
Essential Skills/Experience:
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
Excellent scientific writing skills; regulatory writing background preferred
Familiarity with regulatory documentation management systems eg Veeva Vault
Knowledge of FDA and EMEA regulatory requirements, ICH guidelines and their application
Ability to communicate effectively (written and spoken) in English
Desirable Skills/Experience:
Experience working in cross-functional, global project teams
RAC-Drugs certification
When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're 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 AstraZeneca's Biopharmaceuticals R&D, we are part of the solution, turning our drug development strategies into reality. We work at all stages of development to translate our life-changing science into medicines to get the best results for AstraZeneca, patients in need and healthcare professionals. We are a diverse and open-minded team harnessing our different skills and experiences. Our differences enable us to explore new ideas and ways of doing things. It keeps us on our toes and excited for what's next.
Ready to make a difference? Apply today and be part of our journey to create life-changing medicines!
Please apply with an English Resume
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