Regulatory Strategy Vice President (Pharmaceuticals)

TL;DR

Regulatory Strategy Vice President (Pharmaceuticals): Developing and implementing strategic regulatory plans for biotech, medtech, and specialty pharma companies with an accent on high-quality regulatory services and health authority interactions. Focus on navigating FDA and EMA pathways, managing complex drug development submissions, and leading multidisciplinary teams to ensure clinical compliance.

Location: Must be based in San Francisco, CA or Boston

Salary: From $200,000 USD per year

Company

hirify.global is a leading CRO that helps biotech and pharmaceutical companies transform scientific breakthroughs into approved medicines, devices, and diagnostics.

What you will do

• Supervise, mentor, and motivate reporting associates, conduct performance reviews, and lead hiring efforts to maintain team structure.
• Develop and implement strategic plans aligned with corporate revenue targets and specific regulatory pathways.
• Provide expert consultancy on laws and regulations for clinical trials in the US, Europe, and other international territories.
• Maintain and manage professional relationships with the FDA, EMA, and other key government regulatory agencies.
• Lead the preparation of regulatory strategies, review clinical development plans, and produce regulatory submission materials.
• Partner with Business Development to cross-sell clinical CRO services and support marketing content development.

Requirements

• Minimum BS or MS degree in a science-related field; PharmD or PhD preferred.
• At least 15 years of regulatory experience in pharmaceutical, CRO, or biotech industries, focusing on drug development submissions.
• Minimum 7 years of management experience within a regulatory affairs department.
• Minimum 10 years of experience managing teams.
• Demonstrated track record of successful FDA IND applications and product approvals.
• In-depth knowledge of ICH territories regulations and US/European regulatory application requirements.

Culture & Benefits

• Competitive market-standard compensation package.
• Comprehensive health insurance and retirement plans.
• Paid time off.
• Work environment emphasizing flexibility and balance between professional and personal life.
• Culture where employee ideas influence operational processes and individual voices are valued.