Regulatory Affairs Manager, Global Strategy (Hybrid)

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

Job summary

CSL Behring in the United States (Waltham, MA) seeks a Regulatory leader to drive global regulatory strategies for assigned products, leveraging regional insights and active collaboration with GRAST and GRL. The role focuses on timely, science-driven regulatory outcomes and strong HA engagement (FDA) in a hybrid 3 days onsite model.

You will develop regional knowledge, contribute to core documents, and ensure on-time regulatory activities with cross-functional teams, responsibly maintaining

Qualifications

• Bachelor’s degree in Pharmacy, Biology, Chemistry, Pharmacology, Clinical Medicine, or related life science.
• Advanced degree (MS, PhD, or MD, DVM) or MBA preferred.
• Minimum of 5+ years regulatory/submission experience in biotech/pharma.
• 3+ years experience on developmental products.
• Knowledge of regulatory requirements in EU/US/Japan.
• Experience with agency interactions and complex matrix environments.
• Strong strategic thinking and risk assessment abilities.
• Excellent verbal and written communication across organizational levels.

Responsibilities

• Own regional regulatory activities under GRL, ensuring inputs to strategy and timely submissions.
• Interact with health authorities (FDA/EMA) and engage with GRL/GRAS regions.
• Develop regional knowledge of filing pathways, requirements, and processes.
• Contribute to core documents (briefing books, pediatric plans) and health authority engagements.
• Maintain regulatory systems (e.g., Veeva) and support GRAST activities.

Skills

Regulatory strategy

Global/regulatory affairs

Strategic thinking

Cross-functional collaboration

Verbal and written communication

Relationship management

Education

Bachelor’s degree in Pharmacy/Biology/C Chemistry/Pharmacology/Clinical Medicine

Advanced degree (MS/PhD/MD/DVM) or MBA preferred

Job description

CSL Behring in the United States (Waltham, MA) seeks a Regulatory leader to drive global regulatory strategies for assigned products, leveraging regional insights and active collaboration with GRAST and GRL. The role focuses on timely, science-driven regulatory outcomes and strong HA engagement (FDA) in a hybrid 3 days onsite model.

You will develop regional knowledge, contribute to core documents, and ensure on-time regulatory activities with cross-functional teams, responsibly maintaining