Regulatory Site Officer - #54205

Title: R2863734 Regulatory Site Officer

Location: Geel- Belgium

Work Arrangements: Hybrid (3 days on site, 2 days home office)

About This Opportunity

Join Sanofi's Geel site as a Regulatory Site Officer, acting as the critical regulatory interface between site operations and Global Regulatory Affairs. You'll ensure CMC compliance, support product registrations, and safeguard regulatory alignment across manufacturing, quality, and project activities — directly contributing to our mission of delivering safe, compliant products to patients worldwide.

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Key Responsibilities

Regulatory Compliance

• Ensure CMC dossiers remain aligned with site manufacturing and quality control procedures
• Act as regulatory expert within project teams, providing accurate regulatory intelligence aligned with current guidelines and Health Authority expectations
• Review and approve GMP site documents (Specification Sheets, Stability Protocols/Reports, Validation & Qualification Protocols/Reports, Analytical and Process Comparability Plans/Reports) to ensure alignment with registered details

Change Control & Deviations

• Pre-assess regulatory impact of proposed changes and manage regulatory implications
• Provide regulatory input for deviation investigations, assessing compliance impact
• Serve as the Geel site's regulatory interface with Global Regulatory Affairs and external partners

CMC & Regulatory Documentation

• Author/support CMC regulatory dossiers and supporting documents for clinical, marketing authorization, and post-approval change applications globally
• Author/support timely responses to Health Authority information requests and deficiency letters (CMC and inspection-related)
• Maintain product licenses: support renewals, annual product reports, site registrations, and transfers
• Identify documentation needs for regulatory submissions and flag potential quality, content, or timeline issues
• Negotiate timely delivery of high-quality technical source documents per project and regulatory timelines

Transversal Activities

• Act as primary contact with Global Regulatory Affairs and external regulatory partners
• Participate in and support site inspections and audits

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What We're Looking For

Education & Experience

• Master's degree (or equivalent) in Biotech, Life Sciences, or Pharmaceutical Sciences
• 3-5 years' experience in the Biotech industry
• Prior CMC Regulatory Affairs experience preferred
• Experience in manufacturing/quality operations, Health Authority interactions, and scientific writing preferred
• Knowledge of regulatory registration/maintenance, GMP, and health-related regulations preferred

Technical Skills & Competencies

• Highly proficient English (oral & written)
• Strong technical/scientific writing skills with attention to detail
• Familiarity with CTD Dossiers
• Knowledge of ICH, EMA, and FDA Guidelines
• Proficient in Word, Excel, PowerPoint; experience with Regulatory Information Management systems
• Effective cross-functional collaboration (Global Regulatory Affairs, Global Quality, Supply Chain, iCMC)

Core Competencies

• Strong prioritization skills; delivers against challenging deadlines
• Analytical, transparent, and hands-on troubleshooting approach
• Excellent interpersonal and communication skills
• Comfortable working in a matrix organization and cross-functional project teams
• Strong organizational and negotiation skills

Pursue Progress. Discover Extraordinary.

Join Sanofi and step into a new era of science - where your growth can be just as transformative as the work we do. We invest in you to reach further, think faster, and do what’s never-been-done-before. You’ll help push boundaries, challenge convention, and build smarter solutions that reach the communities we serve. Ready to chase the miracles of science and improve people’s lives? Let’s Pursue Progress and Discover Extraordinary – together.

At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity, protected veteran status or other characteristics protected by law.

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