Nonclinical Submission Manager – Manager

AstraZeneca • Gaithersburg, MD

4d • Hybrid

About The Position

At AstraZeneca, we work together across global boundaries to make an impact and find answers to challenges. We do this with the upmost integrity even in the most difficult situations because we are committed to doing the right thing. We continuously forge partnerships that help pursue world-class medicines in new ways, combining our people’s exceptional skills with those of people from all over the globe. As a Nonclinical Submission/ Established Brand Manager within the Nonclinical Submission Group, you will play a pivotal role in managing the planning, preparation and finalisation of all nonclinical contributions to regulatory submissions. You will also play a key role in the maintenance of our Established Brands. This is an exciting time to join AstraZeneca. We’re looking for an experienced Nonclinical Submission Manager/Established Brand Manager to join our team in Gaithersburg, where we have invested in state-of-the-art research centres, and work in an environment where you’ll feel valued and energised to help drive and shape our function.

Requirements

• BSc or MSc in a scientific discipline related to drug or biologics development with 3+ years of experience
• Previous experience supporting initial market applications and major life-cycle management regulatory submissions
• Validated 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
• Experience of regulated document management systems
• Knowledge of FDA, EMA, ROW regulatory requirements, ICH guidelines and their application
• Demonstrated ability to set and lead priorities, resources, goals and project timelines

Nice To Haves

• Previous experience working in cross-functional, global project teams supporting global regulatory submissions, including health authority interactions and regulatory defence
• Excellent scientific writing skills; regulatory writing background preferred
• Demonstrated application or development of AI tools to support regulatory submissions
• Related certifications – RAC, PMP, etc.

Responsibilities

• Lead the planning, preparation and finalisation of all nonclinical contributions including SEND datasets to regulatory submissions throughout the product lifecycle.
• Responsible for leading a portfolio of projects to agreed targets and quality standards.
• Work with AstraZeneca nonclinical scientists and regulatory colleagues.
• Manage the planning, preparation and finalisation of all nonclinical contributions to regulatory submissions.
• Play a key role in the maintenance of our Established Brands.

Benefits

• qualified retirement program [401(k) plan]
• paid vacation and holidays
• paid leaves
• health benefits including medical, prescription drug, dental, and vision coverage

What This Job Offers

• Job Type: Full-time
• Career Level: Manager