Senior Regulatory Submissions Lead (Biotech)

TL;DR

Senior Regulatory Submissions Lead (Biotech): Leading and executing regulatory strategies and clinical trial submissions for complex multi-region studies with an accent on CTIS management, regulatory compliance, and sponsor coordination. Focus on driving start-up readiness, ensuring high-quality submission documentation, and providing expert leadership across the study lifecycle.

Location: United States

Salary: From $145,000 USD

Company

hirify.global is a global clinical research organization helping biotech, medtech, and pharma companies transform breakthrough science into life-changing medical innovations.

What you will do

• Lead and execute regulatory strategy, submissions, and approvals for multi-region clinical trials throughout the study lifecycle.
• Act as the primary regulatory lead for sponsors, ensuring alignment on timelines, submission strategies, and document readiness.
• Own submission documentation quality, including application forms, cover letters, and country-specific submission packages.
• Drive start-up readiness by coordinating greenlight packages and site activation strategies in partnership with functional teams.
• Maintain operational excellence and compliance with evolving regulations, including direct leadership of activities within the CTIS system.
• Provide subject matter expertise, mentor junior staff, and contribute to business development and proposal strategy.

Requirements

• University degree in pharmacy, medicine, or related natural sciences.
• 8-10 years of experience, with at least 6 years as a Regulatory Submissions Lead or equivalent.
• Proven experience managing complex global clinical trials and CTIS systems.
• Excellent knowledge of ICH/GCP, FDA guidance, EU regulations, and ISO14155.
• Ability to work accurately and interpret complex regulatory directives and guidelines.
• Strong organizational skills with a commitment to meeting deadlines and budget objectives.

Culture & Benefits

• Comprehensive benefits package including health insurance and retirement plans.
• Focus on professional growth, skill development, and work-life balance.
• Collaborative environment where individual ideas influence operational processes.
• Commitment to equal opportunity and inclusive workplace practices.