Excelya este o organizație globală de cercetare contractată (CRO) care ajută companiile de biotehnologie, farmaceutice și de dispozitive medicale să dezvolte și să furnizeze produse pentru sănătate. Activă în 28 de țări, compania oferă soluții complete, servicii funcționale (FSP) și soluții de asigurare a resurselor pentru o gamă largă de arii terapeutice. Abordarea sa colaborativă și flexibilă le oferă clienților expertiza și capacitatea de execuție necesare pentru a avansa terapii care schimbă vieți.
Senior Regulatory Affairs CMC Consultant — France (Remote)
Lead global Regulatory CMC strategy for biologics and antibody-drug conjugate programs at Excelya. Direct MAA and BLA preparation, Module 3 content, lifecycle activities, and health-authority engagement.
Descriere
- Lead global Regulatory CMC strategy for biologics and antibody-drug conjugate programs
- Direct global BLA and MAA preparation, submission, and lifecycle management
- Ensure CMC regulatory plans support product development and commercialization goals
- Identify regulatory risks and establish proactive mitigation measures
- Oversee the preparation, review, and completion of Module 3 CMC content for international submissions
- Maintain scientific consistency, regulatory compliance, and submission-document quality
- Manage CMC discussions with FDA, EMA, and other international health authorities
- Coordinate responses to regulatory questions, deficiency letters, and agency requests
- Foster collaboration across functions in a global matrix organization
- Apply current ICH, FDA, EMA, and international regulatory knowledge to biologic and ADC registration and lifecycle management
Cerințe
- Master’s degree or equivalent in pharmacy, chemistry, life sciences, biotechnology, pharmaceutical sciences, or a related scientific field
- Substantial pharmaceutical-industry experience in Regulatory CMC
- Strong knowledge of biologic products
- Hands-on experience leading Module 3 for biologic MAA and/or BLA submissions
- Working knowledge of ICH, FDA, and EMA requirements for Module 3
- Track record of developing and executing global regulatory strategies
- Fluency in English
Beneficii
- Opportunities to collaborate across an international network
- Programs and opportunities focused on talent development and skill building
- Exposure to a diverse portfolio of high-value healthcare projects
- Work alongside recognized subject-matter experts
- Opportunity to contribute to better patient journeys
- Diverse, equitable, inclusive, and equal-opportunity workplace
- Focus on employee experience