Senior Regulatory Affairs Director, Oncology (Gaithersburg)
AstraZeneca

Gaithersburg, Maryland


Would you like to apply your global Regulatory Affairs strategy expertise and passion to make an impact in a company that follows the science and turns ideas into life changing medicines?

At AstraZeneca, 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 outstanding skills with those of people from all over the globe.

Gaithersburg, MD is one of over 400 sites here at AstraZeneca, providing a collaborative environment where everyone feels comfortable and able to be themselves is at the core of AstraZeneca's priorities, it's meaningful to us that you bring your full self to work every day. This site includes a fitness center, employee healthcare clinic, electric vehicle charging stations, dry cleaning, full-service cafeteria and copy center, game rooms, community garden and more to keep our employees happy and balanced! This modern and vibrant scientific campus is the home of R&D and Oncology in the US.

The Senior Regulatory Affairs Director (SRAD) serves as the Franchise Global Regulatory Lead (GRL) developing and implementing the global strategy on complex oncology programs with multiple indications. In addition, the SRAD has the ability to function in dual capacity by serving as the regional lead based on location. The SRAD establishes external relationships with key stakeholders, leveraging these to maintain competitive advantage. You will be viewed as a senior leader within the Regulatory community.

Within Oncology Regulatory Science and Strategy (ORSS), we bring hope and solutions to patients with unmet needs across the globe. Our regulatory professionals take innovative regulatory approaches to bring life-changing treatments to patients. We work across our pipeline and the business to get medicines to patients as efficiently and optimally as possible.

What you'll do:

  • Lead a Global Regulatory Strategy Team (GRST) of GRLs within the franchise, contributing members from the regions, emerging markets, RA CMC, Labeling and members of the submission and execution team.
  • Ensure that the strategy is crafted to deliver approval with competitive labeling in keeping with the properties of the product(s) and the needs identified by the business, markets and patients.
  • Lead the assessment of emerging data against aspirations and update Leadership on project risks/mitigation activities.
  • Represent Regulatory Affairs on Global Product Teams (GPTs) providing strategic advice and accountable for all regulatory activities.
  • Own the delivery of all milestones on your team including assessment of the probability of regulatory success based on a detailed assessment of risks and mitigations.
  • Demonstrate strategic leadership skills thereby contributing to effective product development.
  • Promote novel regulatory initiatives internally, and engage externally on the corresponding topics. Lead the development of novel tools and technology.
  • Partner and influence developing views/guidance on a global scale.

Minimum Requirements:
  • Bachelor's degree in a science related field with at least 6 years of Regulatory Affairs or related knowledge/experience.
  • Previous demonstrated experience of global regulatory drug development to at least one major regulatory approval including leading strategy, response team, and labeling negotiations.
  • Previous experience in leading global health authority interactions.
  • Solid knowledge of regulatory affairs within multiple therapeutic areas including oncology in early and late development.
  • Broad background of experience working in pharmaceutical business and prior experience in several areas within regulatory affairs with proven leadership experience.
  • Ability to think strategically and critically and evaluate risks to regulatory activities.

Preferred Requirements:
  • Advanced degree preferred.
  • Experience in Oncology (small molecules & biologics).
  • Previous experience with FDA advisory committee and EMA oral explanation is a plus.
  • Previous experience working on due diligence activities and in a business alliance environment.
  • Ability to work strategically within a sophisticated, business critical and high-profile development program.

Next Steps - Apply today!

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 follow all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

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 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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