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Excelya is a global Contract Research Organization (CRO) that helps biotech, pharmaceutical, and medical device companies develop and deliver healthcare products. Operating across 28 countries, the company provides full-service, functional service provider (FSP), and resourcing solutions across a broad range of therapeutic areas. Its collaborative, flexible approach supports clients with the expertise and delivery capacity needed to advance life-changing therapies.
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.
Description
- 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
Requirements
- 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
Benefits
- 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
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