Director Regulatory Intelligence
2 days ago
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?
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 role of Regulatory Intelligence Director. The role will be based at AstraZeneca's dynamic R&D site Gothenburg, Sweden.
The Director Regulatory Intelligence (RID) is accountable for providing disease area Regulatory intelligence, interpretation and impact analysis of the emerging external competitive landscape. You will provide curated analysis across a range of regulatory topics and issues to support product teams and disease area strategies. The RID will work closely with the Senior Director for Regulatory Intelligence within the TA Regulatory Affairs group to 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. 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 regulatory affairs along with the ability to analyze, summarize, and clearly communicate key regulatory insights.
In your role as RID, you will:
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Conduct analysis and impact assessment of Regulatory Intelligence across the portfolio (e.g., precedents, relevant guidance, approval summaries) in a given disease area and communicate findings to key stakeholders and senior leaders within the Company.
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Provide analysis on EMA, FDA, and/or other global Health Authority trends, perspectives, reports, analyses, activities, etc.
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Collaborate with 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.
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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
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Liaise with GRPI in soliciting input and coordinating feedback from key stakeholders in the TA on draft Regulatory guidance documents and Regulatory policies.
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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.
Essential for the role
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Advanced degree in a science related field and/or other appropriate knowledge/experience.
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At least 5 years of demonstrated ability in regulatory strategy or regulatory intelligence.
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Proficiencies in data impact analysis, strategic thinking, creative problem solving and excellent oral and written communication skills.
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Ability to evaluate the impact of key Regulatory Intelligence on disease area and project strategy.
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Ability to critically distinguish between "noise" and relevant news to key collaborators and senior leaders
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You have a solid understanding about Regulatory Intelligence Tools and stay current with Regulatory news regarding key competitors and the disease area.
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Experience working cross-functionally with diverse stakeholders.
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Experience working in drug development including but not limited to, pharmaceutical/biotech industry and government.
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Detailed understanding of US and European regulatory affairs and an understanding of the broader regulatory ecosystem.
At AstraZeneca, we believe in the power of unconventional collaboration-when diverse minds come together, innovation is infinite, resulting in life-changing advancements. While we work in the office at least three days a week, we embrace flexible working that respects personal needs and drives productivity.
So, what's next?
We look forward to find out more about you. Send in your application (resume and cover letter) no later than 16th March 2025.
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