Senior Global Regulatory Lead – Hybrid, Global Strategy

CSL; Waltham (MA); Hybrid; USD 242,000 - 270,000; Full time

Benefits offered by this job

Hybrid work arrangement

Competitive compensation package

Job summary

CSL Behring seeks a Director, Senior Global Regulatory Lead to steer global regulatory strategies across the product lifecycle. You will work with Product Strategy Teams, lead regulatory submissions, and partner with Clinical Development, Safety, and Commercial teams to align regulatory plans with business goals.

We value a strategic thinker with strong communication skills and a track record of guiding complex programs through FDA/EMA processes.

Qualifications

• Minimum 10 years of experience in biotechnology/pharmaceutical regulatory affairs.
• 5+ years leading teams in global regulatory settings.
• Experience interacting with health authorities (FDA/EMA) across regions.

Responsibilities

• Develop global regulatory strategy across product lifecycle.
• Lead Product Strategy Teams and coordinate with cross-functional partners.
• Manage health authority engagements and regulatory submissions.
• Oversee regulatory intelligence and lifecycle management activities.
• Coach regional regulatory leads and promote global alignment.

Skills

Regulatory strategy

Cross-functional leadership

Regulatory affairs

Strategic thinking

Education

Bachelor's degree in life sciences

Advanced degree preferred

Job description

CSL Behring seeks a Director, Senior Global Regulatory Lead to steer global regulatory strategies across the product lifecycle. You will work with Product Strategy Teams, lead regulatory submissions, and partner with Clinical Development, Safety, and Commercial teams to align regulatory plans with business goals.

We value a strategic thinker with strong communication skills and a track record of guiding complex programs through FDA/EMA processes.