Senior Director Regulatory Intelligence (Competitive Intelligence)
AstraZeneca

Do you have competitive intelligence skills and in-depth knowledge about Regulatory Affairs? 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 transform patient outcomes. This means our people are here to win, we give you a breadth of opportunities to be curious and do cutting edge, 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 acumen to identify and champion innovative and impactful regulatory pathways and drug development strategies to benefit patients.

The role

We now have a great opportunity for you to join our team within Respiratory and Immunology (R&I) in the roles as Senior Global Regulatory intelligence Director. The role can be based at AstraZeneca's dynamic R&D sites in Gaithersburg, MD; Boston, MA or Gothenburg (Sweden).

What you'll do

The Senior Director Regulatory Intelligence (SRID) is accountable for providing disease area Regulatory intelligence, interpretation and impact analysis of the emerging external competitive landscape. You will provide updates on regulatory policy developments that impacts TA programs. As a SRID you will apply innovative ways to establish and maintain a framework for the collection, analysis and integration of key, TA-specific competitor insight. You will also be presenting these insights to guide the regulatory strategies and to influence decision making both in the global project teams and across the development portfolio. As a SRID you will also coach and provide direction for the R&I TA Director Regulatory Intelligence (RID).

The SRID will:

• Work closely with other Intelligence and Policy groups within AZ for example Regulatory Policy, Intelligence and Regional Strategy (PIRS), Clinical Information Science, and Global Insights, Analytics, and Commercial Excellence (GIACE).
  
• Collaborate with TA-VP RA, 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.
  
• Liaise with PIRS on policy matters, lead the AZ responses to health authority draft guidance's in call for comments processes by acquiring input from all relevant AZ skills within the therapeutic area.
  
• 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.
  
• Represent AZ, R&I/RA to trade and scientific associations, serving on working groups and sub-committees; preparing AZ/R&I positions and feedback as appropriate.
  

Essential for the role

• A Bachelors degree in a science related field and/or other appropriate knowledge/experience.
  
• At least 7 years of demonstrated ability in regulatory strategy or regulatory intelligence, including prior experience interacting with and influencing senior leaders in a medium to large organization
  
• 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 and project strategy
  
• Ability to critically distinguish between "noise" and relevant news to key collaborators and senior leaders
  
• You have a solid understanding about Regulatory Intelligence Tools and stays current with Regulatory news regarding key competitors and the disease area.
  
• You have a detailed understanding of drug development and are proactive with a consistent record collaborating across diverse functions
  

Desirable for the role

• Solid understanding of the commercial aspects of drug 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? Brilliant! We have one seat available, and we hope it's yours.

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.

This job has expired.