Vice President, Regulatory Strategy

Location: Boston, MA, United States

Company

hirify.global provides regulatory affairs and clinical research services for biotech, medtech, and specialty pharmaceutical companies developing medicines, devices, and diagnostics.

What you will do

• Develop and implement global regulatory strategies aligned with corporate objectives and revenue targets.
• Lead regulatory strategies, clinical development plan reviews, submission materials, and health authority interactions.
• Advise clients and internal teams on regulatory requirements for preclinical, CMC, clinical development, and marketing authorization.
• Build relationships with the FDA, EMA, government agencies, service vendors, and consultants.
• Oversee project budgets, staff productivity, timekeeping, and client invoicing where applicable.
• Partner with Business Development and Marketing to support revenue growth and cross-sell clinical CRO services.

Requirements

• BS or MS degree in a science-related field required; PharmD or PhD preferred.
• At least 15 years of regulatory experience in pharmaceutical, CRO, biotechnology, or consulting environments.
• At least 7 years of management experience in a regulatory affairs department.
• Experience preparing regulatory submissions in the US and/or Europe.
• Experience with supervisory and financial management responsibilities.
• Demonstrated success with FDA IND applications and product approvals or international equivalents.

Culture & Benefits

• Flexibility and balance to support personal and professional needs.
• Opportunities for professional growth and skill development.
• Collaborative work across multidisciplinary internal and external teams.
• Equal opportunity employment compliant with federal guidelines.