Regulatory Intelligence Director: Strategy & Impact

AstraZeneca; Gaithersburg (MD); Hybrid; USD 186,000 - 279,000; Full time

Benefits offered by this job

401(k) plan

Health benefits

Paid time off

Job summary

AstraZeneca in Gaithersburg, MD, seeks a Director Regulatory Intelligence (RID) to translate emerging regulatory signals into choices for pipeline and marketed assets. Based at our R&I site, you’ll join a diverse team to deliver capabilities supporting strategy and portfolio decisions.

You will partner with senior leaders and cross-functional groups to shorten timelines, strengthen labels, and improve patient outcomes through regulatory intelligence insights.

Qualifications

• Advanced degree in a science related field.
• At least 7 years of demonstrated ability in regulatory strategy, intelligence, and/or policy.
• Detailed understanding of US and European regulatory affairs.
• Proficiencies in data impact analysis, strategic thinking, creative problem solving, and excellent oral and written communication skills.

Responsibilities

• Conduct analysis and impact assessment of Regulatory Intelligence across the portfolio and communicate findings to key stakeholders.
• Collaborate with Regulatory Affairs teams to conduct regulatory research and provide Regulatory Intelligence support.
• Interpret EMA, FDA, and other global Health Authority trends and perspectives.

Skills

Regulatory strategy

US & EU regulatory affairs

Data impact analysis

Cross-functional collaboration

Communication skills

Education

Advanced degree in science related field

Tools

Regulatory Intelligence Tools

Job description

AstraZeneca in Gaithersburg, MD, seeks a Director Regulatory Intelligence (RID) to translate emerging regulatory signals into choices for pipeline and marketed assets. Based at our R&I site, you’ll join a diverse team to deliver capabilities supporting strategy and portfolio decisions.

You will partner with senior leaders and cross-functional groups to shorten timelines, strengthen labels, and improve patient outcomes through regulatory intelligence insights.