Senior Regulatory Affairs CMC Consultant

🔥 9 minutes ago

🇫🇷 France – Remote

⏰ Full Time

🟠 Senior

🚔 Compliance

👻 Ghost score 10%

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Excelya

WebsiteLinkedInAll Job Openings

501 - 1000 employees

Founded 2014

💼 Consulting

🏥 Healthcare

📦 Logistics

Consulting • Healthcare • Logistics

Excelya is a leading global Contract Research Organization (CRO) focused on advancing healthcare through innovative solutions and expert guidance. With a presence in 28 countries, Excelya supports biotech, pharmaceutical, and medical device companies by offering full-service, functional service provider (FSP), and resourcing solutions across a broad spectrum of therapeutic areas. The company's unique business model emphasizes collaboration and flexible services, enabling clients to deliver life-changing therapies effectively.

📋 Description

• Lead and drive the global Regulatory CMC strategy for biologics and Antibody Drug Conjugate (ADC) programs • Provide strategic leadership for global BLA and MAA preparation, submission, and lifecycle management activities • Align CMC regulatory strategies with overall product development and commercialization objectives • Anticipate regulatory risks and develop proactive mitigation plans • Oversee preparation, review, and finalization of Module 3 CMC content for global submissions • Ensure scientific consistency, regulatory compliance, and quality of submission documentation • Lead interactions with global health authorities, including FDA, EMA, and other international agencies, on CMC-related topics • Coordinate responses to regulatory questions, deficiency letters, and agency requests • Drive cross-functional collaboration within a global matrix environment • Maintain expertise in ICH, FDA, EMA, and international regulatory requirements supporting registration and lifecycle management of biologic and ADC products

🎯 Requirements

• Master’s degree or equivalent in Pharmacy, Chemistry, Life Sciences, Biotechnology, Pharmaceutical Sciences, or a related scientific discipline • Solid experience in Regulatory CMC within the pharmaceutical industry • Strong expertise in biologics products • Proven hands-on experience leading Module 3 of biologic MAA and/or BLA submissions • Understanding of ICH, FDA, and EMA regulatory requirements applicable to Module 3 • Demonstrated experience defining and implementing global regulatory strategies • Fluent English required

🏖️ Benefits

• International network and collaboration opportunities • Talent development and skills-building opportunities • Opportunity to work on a wide variety of high-value healthcare projects • Collaboration with recognized experts • Meaningful contribution to improving the patient journey • Equal-opportunity, diverse, equitable, and inclusive working environment • Employee experience focus