Regulatory Affairs Intelligence Director - Oncology
- Experience Level
- Experienced (non-manager)
Would you like to use your Regulatory Intelligence skills to ultimately help get Oncology medicines to patients that need them? If you would please read on...
At AstraZeneca work with diverse minds, all united by a shared passion to learn, grow and discover.
Within Oncology Regulatory Science and Strategy (ORSS) we bring hope and solutions to patients with unmet needs across the globe. As Regulatory professionals working on Oncology products, we work in areas of unmet need and take innovative regulatory approaches to bring life-changing treatments to patients. We work across our pipeline and the business to get medicines to patients as efficiently and effectively as possible.
The Regulatory Intelligence Director (RID) - Oncology is responsible for providing global therapeutic area-specific Regulatory interpretation and impact analysis of emerging competitive intelligence. This role 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). The RID will work closely with Therapeutic Area (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 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. The RID will liaise with International, China, and Japan RADs regarding therapeutic area-specific guidance and regulatory intelligence aspects in each region, contributing to overall Regulatory landscape per disease/scientific platform. You'll be responsible for communicating the Regulatory impact and implications of relevant competitive intelligence within therapeutic area and across the organization as appropriate.
Typical Accountabilities, what you will be doing:
- Conduct analysis and impact assessment of Regulatory Intelligence across the portfolio in a given therapeutic area (TA) and communicate findings to key stakeholders and senior leaders within the therapeutic area..
- Work closely with other Intelligence groups within the company (PIRS, GIACE, Clinical Information Science, etc) to provide the disease area/scientific platform 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 International, China, and Japan RADs regarding TA-specific guidance and regulatory intelligence aspects in each region, contributing to overall Regulatory landscape per disease/scientific platform, and liaise with PIRS in soliciting input and coordinating feedback from key stakeholders in the TA on draft Regulatory guidance documents and Regulatory policies
- 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 analyse Regulatory guidance, precedence, and other asset-specific research projects to support our products and development pipeline per market/region
- Review relevant regulatory assessment documents from agencies to extract key insights in supporting Regulatory landscaping and strategy
- Perform research and analysis of relevant Regulatory hearings providing pre-meeting briefings and post-meeting impact analysis to key stakeholders and senior leaders within the Company
- In coordination with functions in the TA, liaise with Reg Ex/PIRS to support their development and deployment of new technologies, including artificial intelligence, to facilitate regulatory intelligence.
Education, Qualifications, Skills and Experience:
- 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.
Location: Cambridge, UK or Gaithersburg, US
Salary: Competitive + Excellent Benefits
Closing Date: 14th May 2021
Next steps, if the role looks suitable and of interest please apply!