Would you like to apply your expertise to impact the Regulatory Affairs team in a company that follows the science and turns ideas into life changing medicines? Then AstraZeneca might be the one for you!

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.

Our Gaithersburg, Maryland facility creates life-changing medicines for people around the world. This campus employs more than 3,500 experts in our field and is only a short drive from Washington, DC. This modern and vibrant scientific campus is the home of R&D and Oncology in the US. Here, we play host to some of the most cutting-edge technology and lab spaces, all designed to inspire collaboration and cross-functional science. We believe employees benefit from being challenged and inspired at work. We are dedicated to creating a culture of inclusion and collaboration.

The Gaithersburg site offers a variety of amenities to help boost productivity and help keep our employees happy and healthy. This includes a fitness center, employee healthcare clinic, electric vehicle charging stations, dry cleaning, full-service cafeteria and copy center. This is where you’ll find newly-designed, activity-based work spaces to suit a variety of working styles while increasing collaboration between teams.

As a Regulatory Affairs Manager in Gaithersburg, MD, you’ll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients’ lives. The Gaithersburg site offers 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 healthy.

AstraZeneca’s vision in Oncology is to help patients by redefining the cancer-treatment paradigm. A broad pipeline of next-generation medicines is focused principally on four disease areas - breast, ovarian, lung and hematological cancers. As well as other tumor types, these are being targeted through four key platforms - immunotherapy, the genetic drivers of cancer and resistance, DNA damage repair, and antibody drug conjugates, underpinned by personalized healthcare and biomarker technologies.

The Regulatory Affairs Manager (RAM) is a regulatory specialist with project management capabilities responsible for leading the end-to-end planning, coordination, and execution of assigned deliverables. The RAM contributes to regulatory submission strategy, identifying submission risks and opportunities, while leading simple through more sophisticated regulatory applications and leading procedures through approval. The RAM provides regulatory expertise and guidance on procedural and documentation requirements to GRET, GRST and cross-functional teams working flexibly within and across regions to ensure the delivery of business objectives.

Your responsibilities could include, but are not limited to:

• Understand the regulatory framework, including regional trends, for various types of applications and procedures for small and large molecules across all regions.

• Provide regulatory input and submission delivery strategy of all dossiers and all application types per market and/or region. Reviews response documents, study protocols, PSRs, amon others.

• Analysis of regulatory procedures and special designations used during development, authorizations and extension of the product.

• Use and share the best methods during interactions with health authorities and in day-to-day work, while operating in a highly dynamic environment.

• Lead and/or contribute to the planning, preparation (including authoring where relevant) and delivery of simple and with experience, increasingly more sophisticated submissions throughout the product’s life cycle from either a global and/or regional perspective.

• Develop, implement and maintain submission delivery plans, content plans, and proactively provide status updates including regulatory risks and mitigation strategies to designated partners.

• Coordinate the input, maintenance and revision in project plans for assigned projects, and highlight unforeseen changes in resource demand in a timely manner

• Support operational and compliance activities for assigned deliverables, including generatin work requests and submission content plans, submission tracking, TMF, and document management using the support and input of GRO, MCs, CROs and/or alliance partners.

• Provide coaching, mentoring and knowledge sharing within the team and contribute to process improvement.

Minimum Qualifications:

• Relevant BS/BA Degree in Science or related field with 1-3 years of regulatory experience within the biopharmaceutical industry, or at a health authority, or other confirmed experience.

• General knowledge of drug development.

• Strong project management skills.

• Leadership skills, including experience leading multi-disciplinary project teams

Preferred Qualifications:

• Led regulatory deliverables at the project level.

• Detailed knowledge of the drug development process.

• Knowledge of AZ Business and processes

Why AstraZeneca?

At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big. Delivering life-changing medicines is about being entrepreneurial - finding those moments and recognising their potential. Join us on our journey of building a new kind of organisation to reset expectations of what a bio-pharmaceutical company can be. This means we’re opening new ways to work, pioneering cutting edge methods and bringing unexpected teams together. Interested? Come and join our journey.

So, what’s next!

Are you ready to bring new ideas and fresh thinking to the table? Brilliant! We have one seat available, and we hope it’s yours.

Where can I find out more?

Our Social Media, Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/

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