Global Regulatory Strategy Director

AstraZeneca; Cambridge; On-site; GBP 80,000 - 120,000; Full time

Job summary

A leading pharmaceutical company seeks a Senior Regulatory Affairs Director to drive the global regulatory strategy of their innovative products. This role demands a strategic leader with substantial experience in regulatory affairs, aiming to ensure rapid approval and compliance across global markets. The ideal candidate will possess a deep understanding of drug development, regulatory processes, and a proven track record in major approvals.

Benefits

Flexible working hours

Collaborative office environment

Qualifications

• Significant experience in regulatory drug development including product approval/launch.
• Proven experience leading Major Health Authority interactions.
• Experience in relevant therapy areas (small molecules & biologics).

Responsibilities

• Lead the development and implementation of global regulatory strategy for complex products.
• Accountable for regulatory milestones and product maintenance activities.
• Conduct regulatory risk planning and mitigation.

Skills

Strategic thinking

Leadership

Regulatory affairs expertise

Communication skills

Program management

Education

Advanced degree in a science related field

Job description

A leading pharmaceutical company seeks a Senior Regulatory Affairs Director to drive the global regulatory strategy of their innovative products. This role demands a strategic leader with substantial experience in regulatory affairs, aiming to ensure rapid approval and compliance across global markets. The ideal candidate will possess a deep understanding of drug development, regulatory processes, and a proven track record in major approvals.