Director, Regulatory Intelligence & Strategy

AstraZeneca

Cambridge

On-site

GBP 120,000 - 160,000

Full time

14 days+

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Job summary

AstraZeneca in Cambridge seeks a Regulatory Affairs Intelligence Director to turn regulatory signals into decisive strategy across pipelines and marketed assets. You will partner with senior regulatory leaders and cross-functional teams to anticipate guidance shifts and translate data into actions that accelerate development and improve patient outcomes.

In this role, you will drive regulatory landscape analysis, coordinate with international teams, and lead bespoke research for RADs, ensuring

Qualifications

  • Advanced degree in science or related field.
  • Strategic thinking, data/impact analysis, and strong communication.
  • 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 distinguish between noise and meaningful news to key stakeholders and senior leaders.
  • Working knowledge of Regulatory Intelligence tools and current regulatory news regarding key competitors and the disease area.

Responsibilities

  • Lead regulatory intelligence analysis across a therapeutic area for senior leaders.
  • Collaborate with PIRS, GIACE, and Clinical Information Science for interpretation.
  • Coordinate bespoke regulatory research for RADs including strategy, due diligence, and disease area initiatives.
  • Align TA guidance across regions with Reg Ex/PIRS and feedback on policies.
  • Analyze regulatory hearings and provide pre/post meeting briefs to stakeholders and senior leaders.

Skills

Strategic thinking
Data and impact analysis
Oral and written communication
Regulatory Affairs knowledge (US & EU)
Drug development understanding
Regulatory Intelligence tools

Education

Advanced degree in science or related field

Job description

AstraZeneca in Cambridge seeks a Regulatory Affairs Intelligence Director to turn regulatory signals into decisive strategy across pipelines and marketed assets. You will partner with senior regulatory leaders and cross-functional teams to anticipate guidance shifts and translate data into actions that accelerate development and improve patient outcomes.

In this role, you will drive regulatory landscape analysis, coordinate with international teams, and lead bespoke research for RADs, ensuring

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