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Job Details


AstraZeneca

Regulatory Affairs Director – Vaccines and Immune Therapies (R-138539_Gaithersburg)

Pharmaceuticals

All

Yearly

No

Gaithersburg, Maryland, United States

Are you a strategically focused Regulatory Affairs professional and would like to play an integral part in shaping drug development and gaining fast, efficient regulatory approvals? If so, read on...

At AstraZeneca, we work with diverse minds, all united by a shared passion to learn, grow and discover.

The Vaccines and Immune Therapies (V&I) group at AstraZeneca is constantly pushing the boundaries of science to deliver life-changing medicines to patients, with a passion for discovery and a pipeline to show for it. We are utilizing our expertise in virology, microbiology and vaccines to enable novel approaches to prevent and treat infectious disease. We offer a unique and strong collaborative network as part of the AstraZeneca family, as together we explore synergies between small and large molecules and novel biologics platforms. Within V&I Regulatory Science and Strategy, we take innovative regulatory approaches and work across our pipeline and the business to get medicines to patients as efficiently and effectively as possible.

The Regulatory Affairs Director (RAD) is responsible for providing strategic and operational regulatory leadership to the development, commercialization and life cycle management of assigned product(s). The RAD applies knowledge of current local and global regulatory trends to identify future regulatory requirements and strategies and influences regulatory authorities through regular contacts to improve regulatory outcomes.

What you’ll do…

  • Develop and implement the regional or global regulatory strategy, ensuring it is crafted to deliver rapid approval with competitive labelling that is identified by the business, markets and patients
  • Lead the development of the global regulatory strategy document for assigned product(s) and the planning and construction of the global dossier and core prescribing information
  • Lead cross functional teams in major regulatory submissions (BLA/MAA/IND/CTA), health authority interactions, label discussions, and securing approvals
  • Deliver regulatory milestones for assigned project(s), including the assessment of risks and mitigations, emerging data and the probability of regulatory success
  • Ensure effective collaboration across global, regional and local Regulatory Affairs, enabling rapid and effective submissions, approvals and other product maintenance activities
  • Participate in skill-development, coaching and performance feedback of other regulatory staff working on the product/project

Essentials for the Role

  • Bachelor’s Degree in a life science or related field
  • Significant experience in early and late-stage regulatory drug development, manufacture, commercialization or equivalent
  • Knowledge of regulatory procedures and legislation for drug development, product registration, line extensions and license maintenance
  • Proven successful leadership and project management experience

Desirables for the Role

  • Previous experience in vaccines or immune therapies is strongly preferred
  • Advanced degree in science related field and/or other appropriate knowledge/experience
  • Ability to work strategically within a business-critical and high-profile development program
  • Critical thinking on current global regulatory science questions and a good understanding of the corresponding scientific and clinical components

Locations: Gaithersburg, Maryland; Durham, North Carolina; Cambridge, United Kingdom; Gothenburg, Sweden

Next Steps

Are you already imagining yourself joining our team? Good, because we can’t wait to hear from you. Please apply via the link and one of our team will be in touch

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, sex, gender, gender expression, sexual orientation, age, marital status, veteran status, or disability status. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

AstraZeneca has taken critical steps to protecting colleagues, loved ones, and patients from COVID-19 and its variants. COVID-19 vaccination is required for all US employees, and weekly PCR COVID-19 testing is required for those who are unvaccinated or have an approved accommodation.



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 authorisation and employment eligibility verification requirements.