GCP Consultant

About Onyx BioPartners

Onyx BioPartners is a life-sciences regulatory and quality consultancy working with biotech, medtech and pharmaceutical clients across the EU and GCC. Together with our partner RegDev, we're expanding our network of seasoned GCP consultants to support client engagements across manufacturing quality, compliance and inspection readiness.

The role

We're building a bench of independent GCP (Good Clinical Practice) consultants we can bring into client projects. Engagements are project-based and vary in length — from focused inspection-readiness and audit work to longer clinical quality and remediation support. You'll work directly with sponsors, CROs and study teams, often as the senior GCP voice in the room.

What you'll do

• Lead or support GCP inspection readiness and host regulatory inspections (sponsor, CRO and site level)
• Conduct site, vendor/CRO and process audits, and follow through on CAPAs
• Provide clinical trial oversight and quality management across Phases I–IV
• Strengthen Trial Master File (TMF) quality, documentation and data integrity (ALCOA++)
• Support sponsor oversight, vendor qualification and risk-based quality management
• Prepare study teams and sites for interactions with regulatory authorities

What we're looking for

• Substantial hands-on GCP experience in clinical trials, across pharma, biologics or devices
• Direct experience with one or more regulatory authorities — e.g. FDA, EMA, MHRA, SFDA, Swissmedic, national EU bodies (BfArM, ANSM, AIFA, AEMPS), the UAE (MOHAP / DoH / DHA) or GCC-wide via the Gulf Health Council
• Strong working knowledge of ICH E6 (GCP) and applicable clinical trial regulations
• A track record of real inspection or audit outcomes you can speak to
• Ability to work independently and travel when a project requires it

Nice to have

• GLP or pharmacovigilance (GVP) experience
• Experience across multiple markets (EU + GCC especially)
• Additional languages

How to apply

Apply through Indeed with your CV. In a short cover note, please tell us which agencies and GCP frameworks you've worked with directly, and one engagement where your expertise changed the outcome.

Pay: From AED1,850.00 per hour

Ability to commute/relocate:

• Dubai: Reliably commute or willing to relocate with an employer-provided relocation package (Required)

Education:

• Master's (Required)

Experience:

• GCP: 10 years (Required)

Willingness to travel:

• 50% (Required)

Work Location: Hybrid remote in Dubai