Established Brand Submission Manager

AstraZeneca UK

Location: Cambridgeshire, Gaithersburg, Maryland

Job Type: Full time


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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 Established Brand Submission 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 Established Brand Submission Manager to join our team in Cambridge or 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 responsibilities

As a Established Brand 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 will also work with Global Regulatory and Patient Safety colleagues and be accountable for the routine nonclinical maintenance activities (licence renewals, literature surveillance, responding to health authority requests) supporting AstraZeneca’s portfolio of establish brand products.

Essential requirements

  • 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 requirements

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

Next Steps – Apply today!

To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience – it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity. If you know someone who would be a great fit, please share this posting with them.

AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law.

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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.

AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.

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