Associate Regulatory Affairs Director

Would you like to apply your Regulatory Affairs expertise and passion to make an impact 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 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 Associate Regulatory Affairs Director (ARAD) is an experienced regulatory professional with understanding of regional regulatory strategy.  The ARAD is responsible for leading the end-to-end planning, coordination, and execution of assigned deliverables and contributes strategic insight into the development, commercialization and life cycle management of assigned products.

The ARAD leads simple through more complex regulatory applications and provides regulatory expertise and guidance on procedural and documentation requirements to the global regulatory strategy team and cross-functional teams, working flexibly within and across regions to ensure the delivery of business objectives. The ARAD contributes to regulatory strategy by identifying risks and opportunities, leading review of regulatory and competitive intelligence, supporting interactions with health authorities, and taking responsibility for license maintenance activities.

Accountabilities/Responsibilities:

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

• Support regulatory intelligence activities activities to inform strategic decision making. Support preparation of the cross functional team and participate in / lead (as appropriate) key health authority consultations.

• May assume assigned responsibilities for routine and non-routine contact with health authorities and marketing companies.  Review and approve content of responses to queries form HAs. 

• Provide strategic regulatory input on key documents including: Submission delivery strategy of all dossiers and all application types per market and /or region. ○ ○ Review of documents (e.g. response documents, PSRs, etc.).

Minimum Qualifications:

BS in science or related discipline.  Advanced degree is preferred but not required.

• Experience within the biopharmaceutical industry, or at a health authority, or other relevant experience, with 1+ years experience. With some experience in regulatory strategy • • General knowledge of drug development • Leadership skills, including experience leading multi-disciplinary project team

Desired Qualifications:

• Strategic regulatory experience in oncology drug development

• Thorough knowledge of the drug development process

The annual base salary for this position ranges from $ 135,182.40 - 202,773.60 USD

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.