Regulatory Affairs Intelligence Director, Cardiovascular, Renal and Metabolism
AstraZeneca

Gaithersburg, Maryland

Posted in Pharmaceuticals
about 1 month ago


This job has expired.

Job Info


The Regulatory Intelligence Director (RID) for Cardiovascular, Renal and Metabolism (CVRM) is responsible for providing disease area specific Regulatory interpretation and impact analysis of emerging competitive intelligence. You will work closely with other Intelligence groups within AZ (Regulatory Policy, Intelligence and Regional Strategy (PIRS), Clinical Information Science, and Global Insights, Analytics, and Commercial Excellence (GIACE). You will be the central point 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. You 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.

You will liaison 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. You will also work closely 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. Will be responsible for communicating the Regulatory impact and implications of relevant competitive intelligence to stakeholders and senior management within AZ

  • Conduct analysis and impact assessment of Regulatory Intelligence across the portfolio in a given disease area and communicate findings to key stakeholders and senior leaders within the Company.
  • Work closely with other Intelligence groups within the company (PIRS, GIACE, Clinical Information Science, etc.) to provide the disease area specific Regulatory interpretation and impact.
  • Serve as the central point person within TA in leading bespoke Regulatory research for RADs including project level Regulatory strategy, due diligence, disease area strategy, initiatives etc.
  • Liaise with PIRS in soliciting input and coordinating feedback from key stakeholders in the TA on draft Regulatory guidance documents and Regulatory policies
  • 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
  • Proactively Conduct analysis of new drug development and regulatory approaches on e.g. novel clinical trial concepts, RWE, early regulatory access, adaptive/conditional licensing as it relates to the TA
  • Research and analyze Regulatory guidance, precedence, and other asset-specific research projects to support our products and development pipeline per market/region
  • Review relevant EPARs and SBOAs to extract key insights in supporting Regulatory landscaping and strategy
  • Perform research and analysis of relevant Advisory Committee hearings providing pre-meeting briefings and post-meeting impact analysis to key stakeholders and senior leaders within the Company
  • Liaise with Reg Ex/PIRS to support their development and deployment of new technologies, including artificial intelligence, to facilitate regulatory intelligence.

Essential for the role
  • An advanced degree in a science related field and/or other appropriate knowledge/experience.
  • Demonstrate competencies of strategic thinking, data and impact analysis, and excellent oral and written communication skills.
  • In-depth knowledge of the designated therapeutic area
  • 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 solid knowledge of US and European Regulatory Affairs
  • Have a good understanding of drug development
  • Are analytical and proactive with a proven ability to collaborate across diverse functions
  • A good understanding of the commercial aspects of drug development
  • 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.

Desirables for the role
  • A good understanding of the commercial aspects of drug development
  • 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.


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