Regional Regulatory Strategy Lead, Global GRAST

CSL; Waltham (MA); On-site; USD 129,000 - 153,000; Full time

Job summary

CSL’s Regulatory leaders leverage regional experience to shape global regulatory strategies with a patient-centric focus. They collaborate with GRAST, GRL, and regional teams to enable timely regulatory outcomes while managing health authority engagements (FDA/EMA) for assigned products.

They contribute to core document preparation, risk assessment, and strategic regulatory planning, while maintaining productive relationships across CSL’s R&D and commercial organizations.

Qualifications

• Bachelor’s degree in Pharmacy or related life sciences. Advanced degree (MS/PhD/MD) preferred.
• 5+ years of regulatory/submission experience in biotech or pharmaceutical industry.
• 3+ years of experience with developmental products.
• Experience interacting with health authorities (FDA/EMA) in at least one key region.
• Ability to work in a complex, matrix environment and communicate effectively.

Responsibilities

• Serve as regulatory lead for assigned products, aligning with GRL and GRAST.
• Develop regional regulatory strategies and assess risks for submissions.
• Contribute to core document preparation and health authority engagements.
• Support modules for submissions and respond to authority comments under guidance.
• Foster relationships across Global Regulatory Strategy and regional stakeholders.

Skills

Regulatory affairs

Strategic thinking

Communication skills

Cross-functional collaboration

Education

Bachelor’s degree in Pharmacy or life sciences

Advanced degree preferred (MS/PhD/MD)

Tools

Veeva systems

Job description

CSL’s Regulatory leaders leverage regional experience to shape global regulatory strategies with a patient-centric focus. They collaborate with GRAST, GRL, and regional teams to enable timely regulatory outcomes while managing health authority engagements (FDA/EMA) for assigned products.

They contribute to core document preparation, risk assessment, and strategic regulatory planning, while maintaining productive relationships across CSL’s R&D and commercial organizations.