Strategic Leader, Regulatory Bioanalysis

AstraZeneca; Gaithersburg (MD); Hybrid; USD 217,000 - 325,000; Full time

Benefits offered by this job

401(k) plan

Health benefits

Paid vacation

Job summary

AstraZeneca in Gaithersburg, MD seeks Head of Regulatory Bioanalysis to lead and advance regulatory bioanalysis across multiple modalities and therapeutic areas. This leadership role requires strategic oversight, mentoring, and collaboration with global health authorities to ensure timely, compliant data delivery.

You will oversee a team of senior scientists, shape regulatory strategies, and drive innovation in data interpretation and quality systems while aligning with portfolio goals and

Qualifications

• PhD or MSc with 10+ years in regulatory bioanalytical leadership.
• Experience leading a bioanalytical team with strategic impact.
• Strong communication and cross-functional collaboration skills.

Responsibilities

• Lead regulatory bioanalysis strategy across the portfolio.
• Mentor and develop talent within the team.
• Collaborate with regulators and Health Authorities across geographies.
• Ensure compliance with regulatory quality systems and data standards.

Skills

Leadership

Verbal and written communication

Strategic thinking

Education

PhD or MSc in a relevant field

Job description

AstraZeneca in Gaithersburg, MD seeks Head of Regulatory Bioanalysis to lead and advance regulatory bioanalysis across multiple modalities and therapeutic areas. This leadership role requires strategic oversight, mentoring, and collaboration with global health authorities to ensure timely, compliant data delivery.

You will oversee a team of senior scientists, shape regulatory strategies, and drive innovation in data interpretation and quality systems while aligning with portfolio goals and