Regional Regulatory Lead: Global Strategy & Impact

CSL Behring; Massachusetts; Hybrid; USD 130,000 - 170,000; Full time

Job summary

CSL Behring seeks a Regulatory Leader to help shape regional and global regulatory strategies with a patient-centric focus. You will collaborate with GRAST, GRL, and regional teams to ensure timely regulatory outcomes and strong HA relationships, including FDA/EMA interactions.

The role is hybrid, based in Waltham, MA or King of Prussia, PA, with a minimum of three onsite days weekly. Minimum 5+ years regulatory/submission experience in biotech/pharma required.

Qualifications

• Bachelor's degree in Pharmacy, Biology, Chemistry, or related life science field.
• Minimum of 5+ years regulatory/submission experience in biotech or pharmaceutical industry.
• 3+ years of experience with developmental products.
• Experience interacting with health authorities in one or more key regions (EU/US/Japan) preferred.

Responsibilities

• Actively contribute to regulatory strategy development and document reviews.
• Ensure timely execution of regulatory activities at regional level.
• Partner with GRL, GRAST and regional teams to deliver regulatory deliverables.
• Maintain relationships with health authorities and support HA engagements.
• Update regulatory systems (e.g., Veeva) to track deliverables.

Skills

Regulatory affairs

Strategic thinking

Verbal & written communication

Education

Bachelor's degree in life sciences

Advanced degree preferred (MS/PhD/MD)

Tools

Veeva

Job description

CSL Behring seeks a Regulatory Leader to help shape regional and global regulatory strategies with a patient-centric focus. You will collaborate with GRAST, GRL, and regional teams to ensure timely regulatory outcomes and strong HA relationships, including FDA/EMA interactions.

The role is hybrid, based in Waltham, MA or King of Prussia, PA, with a minimum of three onsite days weekly. Minimum 5+ years regulatory/submission experience in biotech/pharma required.