Senior Global Regulatory Submissions Lead

Premier Research Group; United States; Remote; USD 140.000 - 180.000; Vollzeit

Zusammenfassung

Premier Research Group seeks a Regulatory Submissions Lead II to join our Regulatory Submissions and Contracts team in the United States. The role focuses on guiding regulatory strategies, submissions, and approvals across regions for complex studies.

You will lead submission content quality, coordinate cross-country filings, and partner with sponsors to ensure timely regulatory success while supporting start-up readiness and governance. A strong background in EU and US regulations is preferred.

Qualifikationen

• Education to university degree level (pharmacy, medicine or related natural sciences are a plus).
• Hands-on experience with EU CTIS Part I submissions, US IRB oversight, and Argentine submission processes are a must.

Aufgaben

• Lead and execute regulatory strategy, submissions, and approvals across all participating countries throughout the study lifecycle by developing and managing regulatory and start-up project plans.
• Act as the primary regulatory & submissions lead for sponsors and project teams, ensuring alignment on timelines, deliverables, submission strategies, document readiness, and regulatory requirements.
• Own submission documentation and regulatory content quality by preparing, reviewing, and securing sponsor approval of core submission documents and country-specific submission packages.
• Drive start-up readiness by defining Greenlight Package templates and coordinating country/site activation strategies.
• Maintain regulatory and start-up excellence, stay current with evolving regulations, and monitor study start-up budgets and obligations.

Kenntnisse

Regulatory submissions

Start-up coordination

CTIS Part I

FDA/EU regulations

Team leadership

Ausbildung

University degree in Pharmacy/Medicine/related natural sciences

Jobbeschreibung

Premier Research Group seeks a Regulatory Submissions Lead II to join our Regulatory Submissions and Contracts team in the United States. The role focuses on guiding regulatory strategies, submissions, and approvals across regions for complex studies.

You will lead submission content quality, coordinate cross-country filings, and partner with sponsors to ensure timely regulatory success while supporting start-up readiness and governance. A strong background in EU and US regulations is preferred.