Regional Regulatory Lead — Hybrid, US, Equity Eligible

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

Job summary

CSL Behring seeks a Regulatory Leader based in the U.S. (Waltham, MA) with a hybrid work model requiring at least 3 days onsite weekly.

You will contribute to an integrated regulatory vision, partnering with GRL, GRAST, and regional teams to drive timely regulatory outcomes for developmental, new, and marketed products. You will guide regional regulatory activities, help prepare key documents, and engage health authorities (FDA/EMA) while aligning with global strategy and ensuring compliant

Qualifications

• Bachelor’s degree in Pharmacy, Biology, Chemistry, Pharmacology, Clinical Medicine, or related life science field.
• Minimum of 5+ years of regulatory/submission experience in the biotech or pharmaceutical industry.
• 3+ years of experience working on developmental products.
• Knowledge and understanding of regulatory requirements for product development and approval in EU, US, and Japan.
• Experience with agency interaction responsible with at least one health authority is preferred.
• Strong strategic thinking, risk assessment, and proactive communication across matrix teams.

Responsibilities

• Manage assigned product relationships with health authorities (FDA/EMA) and coordinate with GRL and regulatory teams.
• Develop regional regulatory knowledge and provide guidance to internal stakeholders on regulatory pathways and risks.
• Support core document preparation, including briefing books and health authority engagements.
• Contribute to GRAST activities, strategy development, and regulatory intelligence; ensure on-time execution of regional activities.
• Maintain regulatory systems (e.g., Veeva) for tracking and compliance.
• Promote CSL leadership capabilities and foster collaboration across R&D and Commercial.

Skills

Regulatory experience

Regulatory submissions

Cross-functional collaboration

Education

Bachelor’s degree in Pharmacy, Biology, Chemistry, Pharmacology, Clinical Medicine, or related life science

Advanced degree (MS, PhD, MD, or MBA) preferred

Job description

CSL Behring seeks a Regulatory Leader based in the U.S. (Waltham, MA) with a hybrid work model requiring at least 3 days onsite weekly.

You will contribute to an integrated regulatory vision, partnering with GRL, GRAST, and regional teams to drive timely regulatory outcomes for developmental, new, and marketed products. You will guide regional regulatory activities, help prepare key documents, and engage health authorities (FDA/EMA) while aligning with global strategy and ensuring compliant