Global Regulatory Submissions Lead II

11 Premier Research International LLC; North Carolina; Vor Ort; USD 120.000 - 180.000; Vollzeit

Zusammenfassung

Premier Research is seeking a Regulatory Submissions Lead II to join our Regulatory Submissions and Contracts team. You will lead regulatory strategy, prepare submissions, and navigate global requirements across studies and products, including CTIS and US IRB processes.

You will mentor junior staff, manage timelines, coordinate with sponsors, and ensure compliant, high-quality documentation while aligning with project goals and budgets.

Qualifikationen

• 8–10 years’ experience in regulatory submissions leadership.
• Experience with CTIS and US IRB oversight.
• Knowledge of ICH/GCP, FDA/EU rules and drug/device development.
• Strong leadership and mentoring skills.

Aufgaben

• Lead regulatory strategy and submissions across multiple regions.
• Develop and manage study start-up plans and CTAs.
• Ensure regulatory content quality and document readiness.
• Identify risks and drive submission timelines with sponsors.
• Coach and mentor junior staff and support business development.

Kenntnisse

Regulatory submissions

Regulatory strategy

CTIS submissions

Project management

Cross-functional collaboration

Ausbildung

University degree (pharmacy/medicine/science)

Jobbeschreibung

Premier Research is seeking a Regulatory Submissions Lead II to join our Regulatory Submissions and Contracts team. You will lead regulatory strategy, prepare submissions, and navigate global requirements across studies and products, including CTIS and US IRB processes.

You will mentor junior staff, manage timelines, coordinate with sponsors, and ensure compliant, high-quality documentation while aligning with project goals and budgets.