Associate Director, Global Regulatory Intelligence

Telix Pharmaceuticals (AMER); United States; Hybrid; USD 150,000 - 190,000; Full time

Job summary

Telix Pharmaceuticals is seeking an Associate Director, Regulatory Affairs (Regulatory Intelligence) to monitor global regulatory developments and translate them into actionable insights. You will lead regulatory intelligence communications, newsletters, trackers, and reports, working with global teams in a hybrid/remote environment.

The role requires 8+ years in regulatory affairs (6+ in regulatory intelligence), strong knowledge of FDA/EMA/PMDA and ICH guidelines, and exceptional stakeholder

Qualifications

• 8+ years in pharmaceutical regulatory affairs with 6+ years in regulatory intelligence.
• Solid knowledge of FDA, EMA, PMDA and ICH guidelines.

Responsibilities

• Monitor global regulatory developments and assess impact on development programs.
• Develop regulatory intelligence communications, newsletters, trackers, and reports.
• Lead regulatory intelligence meetings and stakeholder discussions.
• Collaborate with Quality, Pharmacovigilance, Clinical, CMC, and Regulatory Affairs to implement changes.
• Manage onboarding/offboarding and provide mentorship within the team.

Skills

Regulatory intelligence

Regulatory strategy

Cross-functional collaboration

Regulatory communications

Attention to detail

Education

Bachelor’s degree in life sciences or related field

Master’s degree preferred

Tools

Regulatory intelligence tools

Job description

Telix Pharmaceuticals is seeking an Associate Director, Regulatory Affairs (Regulatory Intelligence) to monitor global regulatory developments and translate them into actionable insights. You will lead regulatory intelligence communications, newsletters, trackers, and reports, working with global teams in a hybrid/remote environment.

The role requires 8+ years in regulatory affairs (6+ in regulatory intelligence), strong knowledge of FDA/EMA/PMDA and ICH guidelines, and exceptional stakeholder