Senior Regulatory Submissions Lead

Role: Senior Regulatory Submissions Lead responsible for developing and executing global regulatory strategies and managing submissions throughout clinical trial lifecycles. Responsibilities: oversee preparation and submission of CTAs, import/export licenses, and protocol amendments; act as primary regulatory contact ensuring compliance with ICH/GCP, FDA, EU, and other regulations; lead activities within the Clinical Trial Information System (CTIS); review and approve key regulatory and clinical documents; coordinate start-up activities and maintain operational excellence; support risk management and process improvements; provide expert guidance on complex studies including GMO and MedTech; mentor junior staff and contribute to business development. Requirements: university degree in pharmacy, medicine, or related sciences; 8-10 years’ regulatory experience, including 6+ years leading submissions for complex, multi-region clinical trials; strong knowledge of CTIS, GxP, and international regulations; excellent project management, organizational, and communication skills; proven ability to work accurately in fast-paced environments. HighValue: global multi-region clinical trials, complex study management, CTIS system expertise, GMP/GCP/ICH compliance, MedTech or GMO study experience, regulatory leadership in early to late-phase studies. WorkSetup: not specified; travel not explicitly mentioned.