The Senior Regulatory Intelligence Director (SRID) is responsible for providing disease area specific Regulatory intelligence, interpretation and impact analysis of emerging external competitive landscape. The incumbent will also provide updates on Regulatory policy developments that impacts TA programs. SRID is externally recognised expert and he/she leverages wide external network amongst Regulatory professionals to provide cutting edge external insight. SRID applies innovative approaches to establish and maintain a framework for the collection, analysis and integration of key, TA-specific competitor insight and in presenting the insight to influence decision making. SRID makes significant contribution in the TA by providing novel insight that will inform the Regulatory strategy for the drug development projects. The SRID will be responsible for communicating the Regulatory impact and implications of relevant competitive intelligence to stakeholders and senior management within AZ.

This role will work closely with other Intelligence and Policy groups within AZ (Regulatory Policy, Intelligence and Regional Strategy (PIRS), Clinical Information Science, and Global Insights, Analytics, and Commercial Excellence (GIACE). The SRID is the accountable person within TA Regulatory Affairs group in leading bespoke Regulatory research for RADs including disease and project level Regulatory strategy, due diligence, disease area strategy, initiatives.

• Will work closely with TA-VP, Executive Regulatory Science Directors, Global Regulatory Leaders (GRLs) and Regulatory Affairs Directors (RADs) to provide the Regulatory Intelligence aspect of disease areas and product-specific Regulatory strategies.
• Liaise with PIRS on Regulatory policy matters, and lead a coordinated response in providing feedback by obtaining input from key experts and stakeholders in the therapeutic area.
• Also will liaise 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. 
• This role may be either an individual contributor or a line leader.

Essential for the role

• An advanced degree in a science related field and/or other appropriate knowledge/experience.
• At least 5 years of prior experience in regulatory strategy or regulatory intelligence, including prior experience interacting with and influencing senior leaders in a medium to large organization
• Demonstrated competencies of strategic thinking, data and impact analysis, 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 meaningful news to key stakeholders and senior leaders
• Have a working knowledge about Regulatory Intelligence Tools and stays current with Regulatory news regarding key competitors and the disease area.
• Have a thorough understanding of drug development are analytical and proactive with a proven ability to collaborate across diverse functions

Desirables for the role

• A good understanding of the commercial aspects of drug development
• In-depth knowledge of the designated therapeutic area
• Prior line or matrix management experience
• Broad background of experience working in pharmaceutical business and prior experience in several areas within regulatory affairs. Experience in relevant therapy area (small molecules & biologics) is preferred.
• Critical thinking on current global regulatory science trends and questions with a good understanding of the corresponding scientific and clinical components.

Date Posted

Closing Date

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.