Regulatory Affairs Expert

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Argo‑X is a specialist consultancy that delivers flexible, high‑impact staffing to pharma, biotech, medical‑device and diagnostics companies worldwide. Our consultants operate in GxP environments, helping clients accelerate product development while staying fully compliant with evolving regulations.

Profile

• Advanced degree (PharmD, MSc, or equivalent) with ≥ 5 years of regulatory experience in the EU/US.
• Proven track record preparing IND/NDA/MAA submissions, managing variations, and liaising with health authorities.
• Deep knowledge of ICH, EMA, FDA, and local EU member‑state requirements.
• Excellent written and verbal communication; fluency in English (additional EU language a plus).
• Ability to work autonomously and integrate seamlessly into client project teams.

Responsibilities

• Lead regulatory strategy and submission planning for drug‑device combos, biologics, and diagnostics.
• Draft, review, and compile dossiers, labeling, and risk‑management documents.
• Interact with agencies, respond to queries, and negotiate timelines.
• Advise cross‑functional teams on regulatory impact of development decisions.
• Conduct gap analyses, implement corrective actions, and maintain regulatory intelligence databases.

Join a network where your expertise is matched to high‑visibility projects that shape the future of healthcare. Enjoy flexible assignments, competitive rates, and continuous professional development.

Apply now – send your CV and a brief cover letter to info@argo‑x.com.