Regional Regulatory Lead: Global Strategy & Outcomes

BioSpace; Waltham (MA); Hybrid; USD 129,000 - 153,000; Full time

Job summary

CSL Behring is seeking a Regulatory Leader to drive regional regulatory strategies for assigned products, aligning with the Global Regulatory Affairs Strategy Team. The role emphasizes collaboration with GRL, GRAST, and commercial teams to ensure timely and compliant regulatory outcomes.

Based in a hybrid arrangement with onsite requirements in Waltham, MA or King of Prussia, PA, the candidate will lead HA engagements, build regional knowledge, and contribute to core submissions while navigating

Qualifications

• Bachelor’s degree in a life science; advanced degree preferred.
• 5+ years regulatory/submission experience in biotech or pharmaceutical industry.
• 3+ years of experience with developmental products.
• Experience interacting with health authorities (FDA/EMA) preferred.
• Ability to work in a complex matrix environment and communicate effectively.

Responsibilities

• Lead regional regulatory activities and health authority engagements.
• Develop regional regulatory strategies with GRL and GRAST teams.
• Prepare core documents and responses to HA comments under GRL.
• Support timely regulatory submissions and on-time deliverables.
• Maintain regulatory systems (e.g., Veeva) and cross-functional communications.

Skills

Regulatory strategy

Regulatory submissions

FDA/EMA interaction

Cross-functional collaboration

Strategic thinking

Education

Bachelor’s degree in life sciences

Advanced degree (MS/PhD/MD) preferred

Tools

Veeva

Job description

CSL Behring is seeking a Regulatory Leader to drive regional regulatory strategies for assigned products, aligning with the Global Regulatory Affairs Strategy Team. The role emphasizes collaboration with GRL, GRAST, and commercial teams to ensure timely and compliant regulatory outcomes.

Based in a hybrid arrangement with onsite requirements in Waltham, MA or King of Prussia, PA, the candidate will lead HA engagements, build regional knowledge, and contribute to core submissions while navigating