Senior Regional Regulatory Lead, Global Strategy

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

Job summary

CSL is seeking a Regulatory Leader based in a hybrid role with a strong regional focus. You will drive regulatory strategy, interact with health authorities, and coordinate with GRL and GRAST to deliver compliant submissions and timely regulatory outcomes.

Ideal candidates have 5+ years in regulatory affairs, experience with EU/US/Japan requirements, and a proven track record in matrix environments. This role emphasizes leadership, risk management, and collaboration across R&D and Commercial.

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 in EU, US, Japan.
• Experience working in Regulatory Affairs with agency interaction responsibility preferred.
• Experience in a complex, matrix environment.
• Ideal candidates will have clinical or device foundation.
• Demonstrated ability to think strategically and assess prudent risks.
• Proven effective verbal and written communication skills across the organization.
• Foster productive relationships within CSL (R&D and Commercial).

Responsibilities

• Accountable for assigned product relationship with a health authority (FDA or EMA) and alignment with the GRL.
• Provide guidance on regulatory filing pathways, processes and ways of working to internal stakeholders.
• Under the product GRL, supports regional regulatory activities including core document preparation and health authority engagements.
• Contribute to GRAST activities, strategy development, document reviews, and regulatory intelligence.
• Maintain regulatory systems (e.g., Veeva) to track compliance deliverables.
• Apply CSL Leadership Capabilities to leadership and teamwork.

Skills

Regulatory affairs

Strategic thinking

Communication skills

Cross-functional collaboration

Regulatory submissions

Clinical or device background

Matrix environment experience

Leadership

Education

Bachelor's in life sciences

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

Tools

Veeva

Job description

CSL is seeking a Regulatory Leader based in a hybrid role with a strong regional focus. You will drive regulatory strategy, interact with health authorities, and coordinate with GRL and GRAST to deliver compliant submissions and timely regulatory outcomes.

Ideal candidates have 5+ years in regulatory affairs, experience with EU/US/Japan requirements, and a proven track record in matrix environments. This role emphasizes leadership, risk management, and collaboration across R&D and Commercial.