Regulatory & Clinical Operations Manager (M/F/X), siRNA | Belgium (hybrid)

pAt Silengenics, we develop precision gene silencing therapies based on siRNA. Our lead drug candidate, in the cardiometabolic space, is moving towards the clinic, and we are looking for the person who will drive that transition. /ph3Your role /h3ulliLead the regulatory pathway of our drug candidate, from regulatory preclinical work through to first in human /liliCoordinate all studies and deliverables required for IND (FDA) and CTA (EMA / CTIS) submissions /liliOversee the operational follow up of our Phase I and Phase II clinical trials /liliAct as the internal point of contact for our consultants, CROs and regulatory and clinical vendors (planning, logistics, deliverables and budgets) /li /ulh3Your profile /h3ulliPharmD, PhD or MSc in pharmaceutical or biomedical sciences, or equivalent /liliProven experience preparing IND or CTA dossiers, including IND enabling studies (GLP toxicology, CMC, pharmacology) /liliHands on experience with at least one Phase I and/or Phase II trial (planning, CRO selection and management, site follow up, timelines) /liliSolid knowledge of European and US regulatory frameworks (EMA, FDA, ICH, GCP); familiarity with the Australian framework is a plus /liliFluent in English; French is a strong asset /liliMajor plus: experience in cardiometabolic diseases (lipids, cholesterol, cardiovascular) and/or oligonucleotide or RNA therapeutics (siRNA, ASO) /li /ulh3What

we offer
/h3ulliBiopark Charleroi (Gosselies, Belgium), with remote work options /lili6 month fixed term contract, convertible into a permanent position /liliA key role at the decisive moment of clinical entry, in a small, ambitious team /li /ulp#Biotech #RegulatoryAffairs #ClinicalOperations #siRNA #Oligonucleotides #DrugDevelopment #Hiring #Belgium /p