Head of Global Regulatory Strategy

Premier Research Group; United States; Remote; USD 180,000 - 350,000; Full time

Job summary

Premier Research seeks a Vice President, Regulatory Strategy to lead global regulatory affairs initiatives. You will guide strategies for assigned therapeutic domains and the 505(b)(2) space, managing client relationships and ensuring compliant submissions across geographies.

You will build and lead a high-impact regulatory team, collaborating with Premier’s clients and regulatory authorities to drive successful approvals while growing the business, including cross-sell of related services.

Qualifications

• Minimum BS or MS degree in a science-related field.
• A PharmD or PhD degree is preferred.
• Fifteen years regulatory experience in pharma/CRO/biotech/consulting.
• At least seven years in a regulatory management position.
• Experience preparing regulatory submissions in the US and/or Europe.
• Experience with supervisory and financial management in regulatory affairs.

Responsibilities

• Develops and implements regulatory strategies aligned with corporate goals.
• Oversees regulatory submissions, budgets, and client invoices.
• Advises on laws, regulations and guidelines for trials in US, Europe, and other countries.
• Maintains relationships with FDA, EMA and regulators to execute global strategies.
• Leads preparation of regulatory strategies and interactions with health authorities.
• Provides guidance to clients and project teams to drive backlog and revenue growth.
• Collaborates with Business Development to cross-sell services.

Skills

Regulatory strategy

Leadership

Education

BS/MS in science

PharmD/PhD preferred

Job description

Premier Research seeks a Vice President, Regulatory Strategy to lead global regulatory affairs initiatives. You will guide strategies for assigned therapeutic domains and the 505(b)(2) space, managing client relationships and ensuring compliant submissions across geographies.

You will build and lead a high-impact regulatory team, collaborating with Premier’s clients and regulatory authorities to drive successful approvals while growing the business, including cross-sell of related services.