Remote Global Regulatory Strategy Lead

Telix Pharmaceuticals Limited; United States; Hybrid; USD 180,000 - 240,000; Full time

Benefits offered by this job

Competitive salary

Bonus programs

Equity incentives

Generous vacation

Wellness days

Learning & development

Job summary

Telix Pharmaceuticals is seeking an Associate Director, Global Regulatory Affairs to lead regulatory activities for the PSMA portfolio across global markets. You will oversee submissions, lifecycle management, and regulatory strategy for clinical and commercial products, coordinating with cross-functional teams to secure timely market access.

The role requires 15+ years in regulatory affairs, strong interactions with agencies (FDA/EMA/TGA/PMDA), and leadership of regulatory teams.

Qualifications

• Degree in Life Sciences, Pharmacy, Regulatory Affairs (advanced degree preferred).
• 15+ years in Regulatory Affairs with leadership experience.
• Strong experience in clinical and commercial regulatory submissions (CTAs, INDs, NDAs, MAAs).
• Proven ability to interact with regulatory agencies and lead health authority interactions.
• Strong knowledge of global regulatory frameworks (FDA, EMA, TGA, PMDA, Health Canada, Medsafe).

Responsibilities

• Lead regulatory strategy and planning for clinical, commercial, and lifecycle management of PSMA Franchise Plan submissions across INDs, NDAs, MAAs, or other filings with cross-functional teams.
• Manage the PSMA portfolio team, ensuring alignment with objectives and timelines.
• Develop and implement strategies for registrations and post-approval changes across the PSMA portfolio.
• Collaborate with cross-functional teams to support regulatory submissions and lifecycle management.
• Coordinate with global authorities (FDA, EMA, TGA, PMDA, etc.) and provide risk assessments to optimize timelines.
• Provide expert regulatory guidance to senior management on risks and opportunities.

Skills

Regulatory leadership

Regulatory strategy

Stakeholder communication

Cross-functional collaboration

Project management

Regulatory submissions

Risk assessment

ICH guidelines

Education

Life Sciences/Regulatory Affairs degree

Advanced degree preferred

Job description

Telix Pharmaceuticals is seeking an Associate Director, Global Regulatory Affairs to lead regulatory activities for the PSMA portfolio across global markets. You will oversee submissions, lifecycle management, and regulatory strategy for clinical and commercial products, coordinating with cross-functional teams to secure timely market access.

The role requires 15+ years in regulatory affairs, strong interactions with agencies (FDA/EMA/TGA/PMDA), and leadership of regulatory teams.