CTA & Regulatory Submissions Lead - EU CTR

Syneos Health France SARL; Paris; Hybrid; EUR 90.000 - 120.000; Vollzeit

Zusammenfassung

Syneos Health is seeking a Site Activation Manager for a sponsor-dedicated role based in Boulogne-Billancourt, near Paris. You will lead regulatory submissions, manage CTAs, and guide cross-functional teams through EU CTR processes to ensure timely activation of trials across sites.

The role requires deep regulatory expertise, strategic submission planning, and the ability to train stakeholders on CTR workflows within a fast-paced, global biopharma environment.

Qualifikationen

• Experience leading regulatory submissions and CTA/CTR processes.
• Strong cross-functional leadership in pharma/biotech environments.
• Familiar with EU CTR regulations and regulatory intelligence.

Aufgaben

• Manage a portfolio of CTAs including preparation and distribution of documentation for new CTAs and maintenance (amendments, end of trial notifications).
• Provide advice on submission strategy and country requirements; support regulatory submission preparation and amendments processing.
• Act as SME on EU CTR submissions, guiding cross-functional teams and training on processes.
• Define CTR transition strategy and initial submission with key stakeholders; adapt processes based on lessons learned.
• Lead CTA-specific scientific advice procedures and advise study teams on options; review related documents.
• Ensure compliant, timely execution of CTA processes and maintain awareness of regulatory requirements.

Kenntnisse

Regulatory submissions

CTA management

Cross-functional leadership

EU CTR submissions

Process improvement

Jobbeschreibung

Syneos Health is seeking a Site Activation Manager for a sponsor-dedicated role based in Boulogne-Billancourt, near Paris. You will lead regulatory submissions, manage CTAs, and guide cross-functional teams through EU CTR processes to ensure timely activation of trials across sites.

The role requires deep regulatory expertise, strategic submission planning, and the ability to train stakeholders on CTR workflows within a fast-paced, global biopharma environment.