Global Regulatory Strategy Lead

Vertex Inc.; Boston (MA); Hybrid; USD 168,000 - 252,000; Full time

Benefits offered by this job

Annual bonus

Equity awards

Commuting benefits

Job summary

Vertex Inc. is seeking a Regulatory Strategy Associate Director in the Boston, MA area to oversee global/regional regulatory strategy for development programs and marketed products.

You will serve as a regulatory lead, coordinating with cross-functional teams to ensure compliant submissions and strategic planning across US, Europe, and international markets. The role requires advanced knowledge of regulatory affairs, drug development, and effective regulatory planning, with opportunity to mentor

Qualifications

• Specialized knowledge of global/regional regulatory affairs frameworks and guidelines.
• Deep understanding of drug development, clinical trial design, statistics, and pharmacology.
• Experience with regulatory submissions and health authority interactions.
• Ability to interpret complex scientific information and regulatory guidance.

Responsibilities

• Lead development and implementation of global regulatory strategy for projects.
• Advise on regulatory requirements and expedited pathways where applicable.
• Manage preparation, submission, and approval of regulatory applications.
• Provide strategic input for development and registration documents.
• Mentor team members and communicate regulatory risks to leadership.

Skills

Regulatory strategy

Regulatory affairs frameworks

Clinical pharmacology

Regulatory submissions

Cross-functional leadership

Regulatory risk assessment

Team mentoring

Education

Bachelor's degree in biology or chemistry

Job description

Vertex Inc. is seeking a Regulatory Strategy Associate Director in the Boston, MA area to oversee global/regional regulatory strategy for development programs and marketed products.

You will serve as a regulatory lead, coordinating with cross-functional teams to ensure compliant submissions and strategic planning across US, Europe, and international markets. The role requires advanced knowledge of regulatory affairs, drug development, and effective regulatory planning, with opportunity to mentor