Global Regulatory Submissions Lead – Start-Up & Strategy

premierresearch; España; On-site; PHP 8,811,000 - 11,957,000; Full time

Job summary

Premier Research seeks a Senior Regulatory Submissions Lead to drive regulatory strategy, submissions, and approvals across multiple regions. You will own CTIS activities, ensure document readiness, and manage complex trial submissions for biotech, medtech, and specialty pharma programs.

You will lead start-up activities, coordinate cross-functional teams, and uphold regulatory quality while mentoring junior staff and contributing to proposals.

Qualifications

• 8–10 years of experience in regulatory submissions roles
• At least 6 years as Regulatory Submissions Lead / Start-Up Lead / Submissions Manager
• Experience managing submissions for complex trials across multiple regions
• Strong knowledge of CTIS and country-specific regulatory requirements
• Excellent knowledge of ICH/GCP/ISO guidelines and FDA/EU regulations
• Ability to manage objectives within budget and timelines

Responsibilities

• Lead and execute regulatory strategy, submissions, and approvals across participating countries
• Coordinate and submit CTAs to Ethics Committees, IRBs, and authorities
• Prepare and review core submission documents (PIF/ICF, forms, letters)
• Ensure country-specific regulatory content quality and compliance
• Define Greenlight Packages and activation strategies with sponsors
• Mentor junior staff and support business development activities

Skills

Regulatory strategy

Project leadership

Risk management

Cross-functional collaboration

Education

University degree in pharmacy, medicine or related natural sciences

Tools

CTIS

Regulatory databases

FDA/EU guidelines

Job description

Premier Research seeks a Senior Regulatory Submissions Lead to drive regulatory strategy, submissions, and approvals across multiple regions. You will own CTIS activities, ensure document readiness, and manage complex trial submissions for biotech, medtech, and specialty pharma programs.

You will lead start-up activities, coordinate cross-functional teams, and uphold regulatory quality while mentoring junior staff and contributing to proposals.