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.
Main duties and responsibilitiesAs a Nonclinical Submission Manager/Established Brand Manager within the Nonclinical Submissions Group you will work with AstraZeneca nonclinical scientists and regulatory colleagues to lead the planning, preparation and finalisation of all nonclinical contributions including SEND datasets to regulatory submissions throughout the product lifecycle. You will be responsible for leading 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 crucial, as is high quality control.
Essential requirements: - BSc or MSc in 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
Desirable requirements- 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.
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.
The annual base salary for this position ranges from $109,245 to $163,867 USD Annual. However, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles) or to receive a retirement contribution (hourly roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an "at-will position" and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.
