Global Regulatory Lead

🔥 0 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

• Develop and maintain global regulatory strategies aligned with development and business objectives • Assess evolving regulatory requirements, competitor landscapes, and regulatory intelligence across major markets • Lead interactions with Health Authorities, including EMA, FDA, PMDA, and other key agencies • Drive regulatory activities related to registrations, lifecycle management, orphan drug designation, and market expansions • Design and oversee global submission plans with regional regulatory teams and submission management • Act as a core member of global cross-functional project teams • Ensure alignment across Regulatory Affairs, Clinical Development, Safety, CMC, Market Access, and other stakeholders • Support preparation and maintenance of CTA/IND documentation, CTD modules, briefing books, regulatory Q&A packages, PIP/PSP activities, and other regulatory deliverables • Lead label development activities and contribute to Company Core Data Sheets (CCDS) • Manage regulatory risk assessments and maintain regulatory risk registers • Support registration activities in key markets and contribute to regulatory due diligence and licensing initiatives when required • Evaluate regulatory impacts of quality, efficacy, or safety findings throughout product development

🎯 Requirements

• Master's Degree, PharmD, PhD, MD, or equivalent scientific qualification • Advanced experience in Regulatory Affairs • Proven expertise in global regulatory strategy, registrations, and lifecycle management within the pharmaceutical or biotechnology industry • Strong knowledge of global regulatory frameworks, including ICH, EMA, and FDA • Experience supporting product development, submissions, and regulatory interactions with Health Authorities • Demonstrated ability to lead cross-functional teams • Ability to influence stakeholders and drive strategic decisions in a complex international environment • Fluent in English

🏖️ Benefits

• Opportunity to contribute to the development of scientific, operational, and human knowledge • Diverse and stimulating projects through a one-stop provider service model • Collaboration with leading experts • Inclusive environment valuing natural talents and individual growth • Opportunities to grow through full-service, functional service provider, and consulting projects • Teamwork-focused healthcare company culture • Employee experience focus • Environment encouraging boldness, boundary-pushing, and development of potential

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