Regulatory Intelligence Director and Decision Analyst

Do you have Regulatory intelligence and Policy skills, with decision analysis capabilities? Do you want to work on innovative projects of high importance for our Respiratory and Immunology portfolio? 

At AstraZeneca, we aspire to be pioneers in science, leading in our disease areas and truly transforming patient outcomes. This means our people are here to win, we give you a breadth of opportunities to be curious and do innovative, unique work that has significant impact on science, medicines, and patients. 

The Global Regulatory Affairs Therapeutic area team that you will belong to is a strategic function within the Respiratory & Immunology Development organization. The Regulatory Affairs team leads the development and execution of regulatory strategies for global programs across the entire lifecycle by proactively leveraging and applying the broad regulatory and scientific expertise, leadership skill and business insight to identify and champion innovative and impactful regulatory pathways and drug development strategies to benefit patients. 

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 role 

We now have a great opportunity for you to join our team within Respiratory and Immunology (R&I) in the role of Regulatory Intelligence Director and Decision Analyst. The role will be based at AstraZeneca’s dynamic R&D site Gaithersburg, MD 

What you’ll do 

The Director Regulatory Intelligence (RID) is accountable for providing disease area Regulatory intelligence, interpretation and impact analysis of the emerging external competitive landscape and supporting Regulatory decision making and risk assessment for the portfolio. You will create curated analysis across a range of regulatory topics and issues to support product teams and disease area strategies. The RID will work closely with senior leaders to drive a framework for the collection, analysis and integration of key TA-specific competitor insight. You will also be communicating these insights to guide the regulatory strategies and to influence decision making both in the global project teams, across the development portfolio, and cross-functionally across the business. The RID must possess the ability to assess the impact of key regulatory developments to provide insights that help inform product development strategies. Thus, the RID, must have a strong background in drug and biologic development regulatory affairs and strong 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 regulatory teams and senior leaders within the Company. 
• Provide analysis on EMA, FDA, and/or other global Health Authority trends, perspectives, reports, analyses, activities, etc. 
• Identify potential opportunities for adoption of novel technology or other innovative tools to enhance regulatory intelligence and strategic analysis. 
• Collaborate with senior leaders, including SVP, VP in R&I TA, Executive Regulatory Science Directors (ERSD), Global Regulatory Leads (GRLs), Senior RADs/RADs and Regulatory Affairs Managers (RAM) to provide the Regulatory Intelligence aspect of disease areas and product-specific Regulatory strategies. 
• Work closely with other Intelligence and Policy groups within AZ, for example Global Regulatory Policy and Intelligence (GRPI), Clinical Information Science, and Global Insights, Analytics, and Commercial Excellence (GIACE) to provide the disease area specific regulatory interpretation and analysis and ensure R&I priorities are reflected in external advocacy efforts. 
• Liaise with GRPI in soliciting input and coordinating feedback from key experts in the TA on draft Regulatory guidance documents and Regulatory policies and drive coordination within the TA. 
• 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. 

Minimum Qualifications:

• Bachelor's Degree in a science related field and/or other appropriate knowledge/experience. 
• At least 10 years of demonstrated ability in regulatory strategy, intelligence and/or policy. 
• Expertise in decision science and/or qualitative and quantitative research methods. 
• 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 of key Regulatory Intelligence on disease area to inform 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 Qualifications:

• 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 experience in working with external trade and scientific associations. 

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 ambitious - finding those moments and recognizing their potential. Join us on our journey of building a new kind of organization to reset expectations of what a bio-pharmaceutical company can be. This means we’re opening new ways to work, groundbreaking methods, and bringing unexpected teams together. Interested? Come and join our journey. 

So, what’s next? 

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

Where can I find out more? 

Respiratory & Immunology,http://www.astrazeneca.com/our-therapy-areas/respiratory-and-immunology.html

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The annual base pay for this position ranges from $186,232.80 to $279,349.20USD. Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. 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), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales 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 pay (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 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.