Director Regulatory Intelligence

Are you ready to transform Regulatory Intelligence into actionable insights for product teams? Do you want to work on innovative projects of high importance for our Respiratory and Immunology portfolio? Join us at AstraZeneca, where we are investing in internal capabilities to discover and accelerate the delivery of next-generation respiratory and immunology modalities for patients. As part of the Respiratory & Immunology (R&I) Regulatory Affairs team, you will play a crucial role in bringing these transformative therapies from the lab to life.

We have a terrific opportunity for you to join our team within R&I Regulatory Affairs as a Regulatory Intelligence Director. This role sits at the intersection of competitive insight, regulatory science, and portfolio strategy translating emerging signals into clear choices for our pipeline and marketed assets. The role will be based at AstraZeneca’s dynamic R&D site Gaithersburg, MD. More specifically, you will be part of the Strategy and Innovation Team which comprises a diverse group of individuals including global regulatory strategists, medical writers, labeling, data analytics, and policy and intelligence areas to deliver a breadth of capabilities to support the TA and portfolio.

The Director Regulatory Intelligence (RID) provides disease area regulatory intelligence, interpretation, and impact analysis of the emerging external regulatory and competitive landscape to support risk assessment and portfolio decisions. You will partner closely with senior regulatory leaders and cross-functional intelligence groups to anticipate shifts in guidance and identify precedents that unlock smarter development pathways. In an agile, collaborative environment, you will help convert complex data into action that shortens timelines, strengthens labels, and improves patient outcomes.

The RID must possess the ability to assess the impact of key regulatory developments and communicate key insights to inform development strategies. Thus, the RID must have a strong background in drug and biologic development regulatory affairs and effective communication skills.

• Conduct analysis and impact assessment of Regulatory Intelligence across the portfolio (e.g., precedents, relevant guidance, approval summaries) and communicate findings to key stakeholders and senior leaders, including R&I Regulatory Affairs VP, Executive Regulatory Science Directors, and Global Regulatory Leads.
• Collaborate with Regulatory Affairs teams to conduct bespoke regulatory research and provide the Regulatory Intelligence aspect of disease area- and product-specific Regulatory strategies.
• Collaborate with other regulatory intelligence groups within AZ to interpret EMA, FDA, and/or other global Health Authority trends, perspectives, reports, activities, etc.
• Identify regulatory opportunities for portfolio acceleration, e.g., novel regulatory pathways, opportunities for adoption of novel technology or innovative evidence generation methods.
• Work closely with Clinical Information Science and Commercial Intelligence and other R&I experts to provide regulatory interpretation and analysis to emerging disease area information.
• Liaise with global regulatory policy and drive coordination within R&I to respond to draft Health Authority guidance documents and ensure R&I priorities are reflected in external regulatory policy engagement.
• Collaborate with International, China, and Japan RADs regarding disease area-specific guidance and regulatory intelligence aspects in each region, contributing to overall Regulatory landscape per disease.
• Identify opportunities and to leverage artificial intelligence and other new tools to simplify business process; drive implementation and adoption of novel technologies to enhance efficiency and facilitate regulatory intelligence activities.

• Advanced degree in a science related field and/or other appropriate knowledge/experience.
• At least 7 years of demonstrated ability in regulatory strategy, intelligence, and/or policy.
• Detailed understanding of US and European regulatory affairs and an understanding of the…