Regulatory Affairs Specialist / Regulatory Scientist

About the role

Join a global team supporting leading pharmaceutical and biotech companies. As a Regulatory Affairs Specialist/Scientist you will work closely with Regional and Global Regulatory Leads to develop and execute regulatory strategies for assigned programs throughout development and post‑approval phases.

Key responsibilities

• Support the Regulatory Lead in creating integrated global and regional regulatory strategies.
• Prepare and compile regulatory documents for Health Authority submissions (iPSPs/PIPs, ODDs, Briefing Books, INDs/CTAs, BLA/MAAs, sBLA/Variations).
• Collaborate with subject‑matter experts to respond to agency queries while maintaining a consistent regulatory voice.
• Monitor the regulatory environment, competitor intelligence and therapeutic area trends to inform strategy.
• Identify regulatory risks and contribute to mitigation plans.
• Act as backup for the Regulatory Lead, ensuring alignment across project teams.
• Review clinical trial plans, protocols and submission schedules for regulatory compliance.
• Provide input on inspections, audits, litigation support and product complaints.
• Support continuous improvement of regulatory submission processes.

Required profile

• University degree in a scientific or biomedical discipline.
• Minimum 3 years of experience in a clinical development environment, preferably in Regulatory Affairs.
• Independent, quick learner with a hands‑on approach.
• Strong interpersonal, leadership and critical‑thinking abilities.

Required skills

• Regulatory submission preparation
• Regulatory strategy development