Senior Global Regulatory Submissions Lead II

Premier Research International; España; On-site; EUR 90,000 - 130,000; Full time

Job summary

Premier Research International in Spain is seeking a Regulatory Submissions Lead II to join our Regulatory Submissions and Contracts team. You will lead regulatory strategy, manage CTIS submissions, and coordinate country-specific filings across Europe for biotech, medtech, and pharma studies.

This role requires deep expertise in ICH/GCP, EU MDR/IVDR, and global submission processes. As a senior leader, you will mentor junior staff, drive process improvements, and partner with sponsors to ensure

Qualifications

• Education to university degree level (pharmacy, medicine or related natural sciences are a plus).
• Hands-on experience with Part I and Part II submissions in CTIS.
• 8-10 years' experience, including at least 6 years' experience as Regulatory Submissions Lead, Start-Up Lead, Submissions Manager, or equivalent.
• Experience in managing submission of complex trials, different IP types and different phases, globally.
• Experience in MD/IVDR and GMO is highly recommended.
• Excellent knowledge of ICH/GCP regulations/country specific regulations as applicable. Excellent knowledge of FDA Guidance Documents/EU Regulations/ISO14155 regulations, drug / device development, and start-up procedures.
• Excellent team player, collaborative and able to build an effective team.
• Ability to multitask and work effectively in a fast-paced envir

Responsibilities

• Lead and execute regulatory strategy, submissions, and approvals across all participating countries during study lifecycle.
• Own submission documentation and regulatory content quality for core submission packages.
• Review essential clinical and regulatory documents to ensure compliance and country-specific acceptability.
• Drive start-up readiness and coordinate country/site activation strategies with cross-functional teams.
• Provide leadership, coaching, and participate in business development activities through client meetings and proposals.

Skills

Regulatory submissions leadership

CTIS Part I/II submissions

Global/regional submissions

MD/IVDR and GMO knowledge

ICH/GCP and FDA/EU regulations

Team leadership & mentoring

Multi-tasking in fast-paced env

Client meetings & bid defenses

Education

University degree in pharmacy/medicine/related sciences

Job description

Premier Research International in Spain is seeking a Regulatory Submissions Lead II to join our Regulatory Submissions and Contracts team. You will lead regulatory strategy, manage CTIS submissions, and coordinate country-specific filings across Europe for biotech, medtech, and pharma studies.

This role requires deep expertise in ICH/GCP, EU MDR/IVDR, and global submission processes. As a senior leader, you will mentor junior staff, drive process improvements, and partner with sponsors to ensure