Hybrid: Senior U.S. Regional Regulatory Lead

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

Job summary

CSL Behring is seeking a Regulatory Leader to contribute to a global, integrated regulatory vision for assigned products. You will partner with Global Regulatory Affairs Strategy Team and regional stakeholders to secure timely, positive regulatory outcomes.

Based in a hybrid role in Waltham, MA (3 onsite days weekly), you will guide regional filings, engage with health authorities, and drive strategic risk-taking while aligning with CSL Behring’s leadership principles.

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 biotech/pharmaceuticals.
• 3+ years of experience on developmental products.
• Knowledge of regulatory requirements in EU, US, Japan.
• Experience with agency interaction and complex matrix environments.
• Ideal candidates have clinical or device foundations.

Responsibilities

• Accountable for assigned product relationships with health authorities (FDA/EMA) and align with GRL.
• Develop regional regulatory knowledge and provide guidance on pathways, risk, and opportunities.
• Support regional regulatory activities and document preparation (core briefing books, pediatric plans).
• Contribute to GRAST activities, strategy development, document reviews, and intelligence.
• Maintain regulatory systems (e.g., Veeva) for tracking and compliance deliverables.
• Apply CSL leadership capabilities to drive agile, bold regulatory outcomes.

Skills

Regulatory strategy

Stakeholder communication

Cross-functional collaboration

Risk assessment

Strategic thinking

Verbal communication

Written communication

Matrix environment

Education

Life science degree

Advanced degree preferred

Job description

CSL Behring is seeking a Regulatory Leader to contribute to a global, integrated regulatory vision for assigned products. You will partner with Global Regulatory Affairs Strategy Team and regional stakeholders to secure timely, positive regulatory outcomes.

Based in a hybrid role in Waltham, MA (3 onsite days weekly), you will guide regional filings, engage with health authorities, and drive strategic risk-taking while aligning with CSL Behring’s leadership principles.