Remote VP, Regulatory Strategy & Global Submissions

Premier Research Group; Boston, Northern (MA, KY); Hybrid; USD 200,000 - 300,000; Full time

Job summary

Premier Research is seeking a Vice President of Regulatory Strategy to lead global regulatory affairs for our clients in biotech, medtech, and pharma. You will shape strategy, drive regulatory submissions, and oversee senior project teams across the US and Europe.

The role requires a PhD/MD preferred, 15+ years in regulatory affairs, and a proven track record with FDA INDs and product approvals. You will mentor staff, manage budgets, and collaborate with business development to grow Premier's

Qualifications

• Minimum BS or MS in a science-related field.
• PharmD or PhD preferred for advanced positions.
• Experience leading regulatory strategies for global regulatory submissions in pharma/biotech.

Responsibilities

• Develops and implements global regulatory strategy for assigned clients and therapeutic areas.
• Leads preparation of regulatory submissions and interactions with health authorities.
• Manages budgets, timelines, and staff to meet productivity and quality targets.
• Partners with business development to grow Premier’s consulting services.

Skills

Regulatory strategy

Leadership

Client relations

Cross-functional collaboration

Regulatory submissions

Education

BS/MS in science

PharmD/PhD preferred

Job description

Premier Research is seeking a Vice President of Regulatory Strategy to lead global regulatory affairs for our clients in biotech, medtech, and pharma. You will shape strategy, drive regulatory submissions, and oversee senior project teams across the US and Europe.

The role requires a PhD/MD preferred, 15+ years in regulatory affairs, and a proven track record with FDA INDs and product approvals. You will mentor staff, manage budgets, and collaborate with business development to grow Premier's