Regulatory Compliance Subject Matter Expert

24 hours ago

Dublin, Dublin City, Ireland DPS Group Global Full time
Regulatory Compliance Subject Matter Expert (SME)

Arcadis is the world's leading company in sustainable design, engineering, and consultancy for natural and built assets. With over 36,000 professionals in 70+ countries, we are united in improving quality of life and solving the world's most complex challenges.

Be part of something impactful – join us

About The Role

Arcadis DPS Group specializes in Project Management, Multi-Discipline Design, and Construction Management for Pharmaceutical and Life Science Buildings.

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

Be part of something impactful – join us

Key Responsibilities

This person will fulfil the following key functions:

  • 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.
  • 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.
  • Client Engagement & Presentations: Support Arcadis's Business Development and proposal teams by delivering capability presentations to clients, displaying expertise and value propositions.
  • Client Relationship Development: Build and manage a client base in the life sciences industry, leveraging expertise to secure specific work assignments such as:
    • Investigating contamination issues in processes and facilities.
    • Supporting operational readiness, including engagement with regulatory authorities.
    • Providing expert guidance during regulatory audits, including EU and FDA inspections.
    • Architecting quality management frameworks and systems tailored to client needs.
    • Developing contamination control strategies aligned with regulatory guidelines and industry best practices.
Experience & Skills Required
  • Extensive Industry Experience: Minimum of 15 years of experience within the life sciences industry, with a focus on regulatory, QA, or related roles.
  • 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 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.
  • Regulatory Knowledge: Comprehensive understanding of applicable regulatory standards, including Eudralex, FDA guidelines, and Annex 1, paired with awareness of emerging regulatory trends and viewpoints.
  • 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.
Why Arcadis?

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.

Our Commitment to Equality, Diversity, and Inclusion

We're dedicated to creating a workplace where everyone can thrive. Through six ED&I workstreams—Age, Disability, Faith, Gender, LGBT+, and Race—we foster innovation by bringing together diverse perspectives. Together, we improve quality of life while building a more inclusive future.

Join Arcadis. Create a Legacy.

Seniority level
  • Mid-Senior level
Employment type
  • Full-time
Job function
  • Legal
Industries
  • Architecture and Planning
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