Palleos is growing fast, and we’re looking for a sharp, structured, scientifically grounded Regulatory Manager to strengthen our clinical development team. If your natural habitat is regulatory frameworks, submission strategies, and clean, compliant documentation — welcome aboard.
Your Responsibilities
As a Regulatory Manager at Palleos, you will play a key role in driving regulatory strategy and ensuring alignment with all applicable requirements across a diverse project portfolio, including clinical trials (drugs and devices) and non-interventional studies. Your responsibilities will include:
- Developing regulatory strategies for clinical trial and non-interventional study submissions across EU/EEA
- Preparing, reviewing, and managing submission packages (CTAs, amendments, device performance study applications, notifications for non-interventional studies, authority responses, etc.)
- Acting as a key liaison with regulatory authorities, ethics committees, and competent bodies for clinical, device, and non-interventional research
- Ensuring compliance with EU-CTR, MDR, IVDR, ICH-GCP, GDPR/data privacy, and national regulations
- Conducting regulatory intelligence to anticipate changes, assess impact on ongoing and planned studies, and proactively communicate updates.
- Advising internal teams and sponsors on country-specific requirements, regulatory pathways and best practices, including GDPR/data privacy for observational and registry studies.
- Contributing to SOP creation and continuous improvement of regulatory processes
What We’re Looking For
- University degree in Life Sciences, Pharmacy, or Medicine (MD or strong scientific background preferred)• Minimum 3 years of regulatory affairs experience in clinical research, medical devices, and non-interventional studies.
- Strong understanding of MDR, IVDR, CTR, ICH-GCP, GDPR, and associated guidelines
- Track record of handling multi-country submissions and navigating country-specific nuances.
- Excellent communication and stakeholder-management skills
- Fluent English
- Highly organized, reliable, analytical, and proactively solution-oriented
What We Offer
- A role in a forward-thinking, science-driven CRO with a dynamic project portfolio.
- Full remote or hybrid setup to suit your work-life balance.
- Competitive compensation
- Opportunities to expand your regulatory expertise across international studies
- Supportive team, lean processes, minimal bureaucracy
- An environment where your scientific and regulatory mindset truly matters
To apply, please submit your resume and cover letter careers@palleos.com.
