Global Regulatory Strategy VP — Drive Life-Saving Approvals

11 Premier Research International LLC; Massachusetts; On-site; USD 180,000 - 260,000; Full time

Job summary

Premier Research is seeking a Vice President, Regulatory Strategy to lead global regulatory affairs for biotech, medtech, and specialty pharma programs. You will shape strategic plans, guide submissions, and partner with regulators and clients to advance medicines and devices.

You will develop cross-border strategies, mentor teams, manage budgets, and collaborate with business development to grow Premier’s services while ensuring compliance and timely delivery across the US, Europe, and beyond.

Qualifications

• Minimum BS or MS degree in a science-related field.
• A PharmD or PhD degree is preferred.
• Experience leading regulatory strategy for pharma/biotech.
• Proven track record with US/EU regulatory submissions.
• Strong budget and team-management capabilities.

Responsibilities

• Develops and implements strategic plans for regulatory services across geographies and modalities.
• Advises on clinical development plans and regulatory submissions.
• Maintains expert knowledge of US/EU regulations and guideline changes.
• Cultivates relationships with FDA, EMA and other regulators and clients.
• Leads cross-functional teams and supports business development initiatives.

Skills

Regulatory Strategy

FDA relationships

Leadership

Strategic Planning

Budget Management

Education

BS or MS in science

PhD or PharmD preferred

Job description

Premier Research is seeking a Vice President, Regulatory Strategy to lead global regulatory affairs for biotech, medtech, and specialty pharma programs. You will shape strategic plans, guide submissions, and partner with regulators and clients to advance medicines and devices.

You will develop cross-border strategies, mentor teams, manage budgets, and collaborate with business development to grow Premier’s services while ensuring compliance and timely delivery across the US, Europe, and beyond.