Regulatory Compliance Subject Matter Expert (SME)

• Architecting quality management frameworks and systems tailored to client needs.
• Providing expert guidance during regulatory audits, including EU and FDA inspections.
• Ensure cGMP Compliance: Collaborate with internal project teams to ensure robust cGMP-compliant facility designs for pharmaceutical, biopharmaceutical, and Advanced Therapy Medicinal Product (ATMP) facilities.
• Supporting operational readiness, including engagement with regulatory authorities.
• Client Relationship Development: Build and manage a client base in the life sciences industry, leveraging expertise to secure specific work assignments such as:
• Developing contamination control strategies aligned with regulatory guidelines and industry best practices.
• Investigating contamination issues in processes and facilities.
• Client Engagement & Presentations: Support Arcadis’s Business Development and proposal teams by delivering capability presentations to clients, displaying expertise and value propositions.
• Regulatory Support: Provide expert guidance to Arcadis clients during live projects, ensuring regulatory compliance across all aspects of facility operation, including equipment, processes, and personnel.

A self-motivated and results orientated person with a proven track record working directly with life science industry clients in a cGMP environment.

• Educational Background:A bachelor’s degree in a relevant Science or Engineering discipline is required; advanced degrees or certifications in regulatory or compliance fields are a plus.
• Regulatory Auditor Interaction:Proven experience interacting with EU, FDA, or other regulatory auditors is highly desirable.
• Business Development Acumen:Demonstrated ability to drive business development efforts and cultivate new client relationships in the life sciences industry is advantageous.
• Specialized Consultancy Expertise:Significant career experience working directly for life sciences companies or specialist consultancies with a focus on regulatory compliance and quality assurance.
• Regulatory Knowledge:Comprehensive understanding of applicable regulatory standards, including Eudralex, FDA guidelines, and Annex 1, paired with awareness of emerging regulatory trends and viewpoints.
• Extensive Industry Experience:Minimum of 15 years of experience within the life sciences industry, with a focus on regulatory, QA, or related roles.

At Arcadis, we empower everyone to be their best because your contribution matters. We take a skills-based approach, allowing you to shape your career and maximize your impact. By joining us, you’ll do meaningful work, delivering sustainable solutions for a better planet and leaving a lasting legacy.