CMC Writer CMC Regulatory · Ghent ·

h3About us /h3pAt bArdena /b, we’re helping shape the future of medicine. Our teams work on the development of innovative and complex therapies that can improve the lives of patients around the world. /ppAs a global Contract Development and Manufacturing Organization (CDMO) and Contract Research Organization (CRO), bArdena /b partners with pharmaceutical and biotech companies to turn scientific ideas into real treatments. From early development to manufacturing and regulatory support, we help bring new medicines to market faster and with the highest quality standards. /ppWith more than 750 colleagues across Europe and the United States, bArdena /b offers expertise in drug substance and drug product development, manufacturing, bioanalytical services, clinical logistics, fill finish, and CMC regulatory support. /ppBut what truly makes bArdena /b special is our people. We are a science-driven and people-focused company where collaboration, innovation, and curiosity are encouraged. /ppWe offer an international environment where you can learn, take initiative, and grow your career across teams, functions, and locations. Our way of working is guided by our CARE values: Communicative, Accountable, Reliable, and Excellent. These values shape how we collaborate, solve challenges, and support each other every day. /ppAt bArdena /b, you’re not just building your career — you’re helping build the future of medicine. /ppFor the Ardena branch based in Gent, Belgium, our CMC Regulatory Team is looking for /ph3(Associate) Scientific Writer – CMC Drug Substance /h3pThe CMC Regulatory team is dedicated to delivering customized and timely regulatory drug development services to our valued customers. Our support spans all aspects of bChemistry, Manufacturing Control (CMC) /b bwriting activities /b across various stages of the drug development process. We collaborate closely with other bArdena /b teams, providing CMC advice throughout drug development and dossier submission. /ph3Position Overview /h3pAs (Associate) Scientific Writer – CMC Drug Substance, you will play a pivotal role in the drug substance process development by contributing to the creation of qualitative documents. This position offers a fantastic opportunity to collaborate with experienced colleagues and gain firsthand experience in the dynamic drug substance field. /ph3Key Responsibilities /h3ullipWrite and compile scientific and technical documents related to the bdrug substance development /b of both new chemical entities and biological products, such as: /pullipsynthesis criticality assessments /p /lilipstarting material justification reports /p /lilipimpurity management reports /p /lilipdocuments related to upscaling of the synthesis process /p /lilipetc. /p /li /ul /li /ulpThese documents may be used as basis for global regulatory submissions (clinical trialapplications, marketing applications, etc.) /pullipEstablishing the control strategy for the drug substance manufacturing (specifications) /p /li /ulullipNitrosamine and mutagenicity assessments per ICH M7 /p /li /ulullipAlignment of the documents to ensure compliance with the latest ICH guidelines /p /li /ulullipProject management/coordination of technical writing and reviewing activities /p /li /ulh3Your Profile /h3h3Education and Interest /h3ullipMaster’s degree or Ph.
D. in chemistry or biotechnology. /p /lilipAffinity with organic chemistry and drug substance development is a plus. /p /lilipPassion for scientific and technical writing for chemical and biopharmaceutical products. /p /lilipStrong interest in drug development and regulatory guidelines. /p /li /ulh3General Skills /h3ullipProficient in MS Office (primarily Word and Excel. /p /lilipVery good communication skills (both written and spoken). /p /lilipFluent in written and spoken English. /p /lilipStrong scientific writing skills. /p /lilipAttention to detail and accuracy. /p /lilipEager to learn and ability to work independently when necessary. /p /lilipProblem-solving skills with a quality-conscious attitude. /p /lilipWell-organized with the ability to work in a dynamic environment. /p /lilipAI savviness is a must /p /li /ulh3What

We Offer
/h3ullipOpportunity to contribute to the development of new drugs. /p /lilipA supportive learning environment for skill development and growth. /p /lilipInvolvement in a rapidly growing international company with an intriguing services, product, and customer portfolio. /p /lilipDynamic working environment with friendly and collaborative colleagues. /p /lilipOpen, straightforward, and caring company culture. /p /lilipAttractive remuneration package with extra-legal benefits such as meal vouchers and group/hospitalization insurance. /p /lilipFlexible

working hours
and the possibility for partial telework. /p /lilipGenerous annual leave entitlement of 32 days. /p /li /ulpJoin us in shaping the future of drug development and be part of a team that values your contributions and personal growth. /ppFor more