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. 

Summary of Role:

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.

Responsibilities:

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.

The RID will:

• 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.

Required Skills and Experience:

• 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 broader regulatory ecosystem.

• Proficiencies in data impact analysis, strategic thinking, creative problem solving, and excellent oral and written communication skills.

• Ability to evaluate the impact and drive change of key Regulatory Intelligence on disease area and project strategy.

• Ability to discern and communicate relevant Regulatory news to key collaborators and senior leaders

• Solid understanding of Regulatory Intelligence Tools.

• Experience working cross-functionally with diverse stakeholders.

• Experience working in BioPharmaceutical development including but not limited to, pharmaceutical/biotech industry and government.

Desirable Skills:

• Solid understanding of the commercial aspects of BioPharmaceutical development

• In-depth knowledge of the R&I therapeutic area

• Broad background of experience working in pharmaceutical business and prior experience in leading competitive intelligence within the pharmaceutical industry or in associated industries

• Critical thinking on current global regulatory science trends and questions with a good understanding of the corresponding scientific and clinical components.

• Previous regulatory policy experience or working with external trade and scientific associations.

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That is why we work, on average, a minimum of three days per week from the office. But that does not mean we are not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

The annual base salary for this position ranges from $186,232 and $279,350 USD Annual. 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.

AstraZeneca is where science meets innovation to create impactful solutions! We challenge the status quo by leveraging data to drive scientific breakthroughs that make a tangible difference in patients' lives. Our collaborative environment fosters learning and growth, empowering you to contribute to meaningful research across global Therapy Areas. With countless opportunities for development, AstraZeneca is committed to investing in technology and expanding knowledge to maximize impact.

Ready to make a difference? Apply now to join our team and be part of something extraordinary!

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