cmc

argenx is building a biotech leadership role in Belgium to steer CMC development plans aligned with clinical strategies, while maintaining start-up roots in science and innovation. The role reports to the Global Head of Technical Operations and drives alignment with trial supply and regulatory expectations.You will lead the CMC Development team across drug...

Join us as we transform immunology and deliver medicines that help autoimmune patients get their lives back. argenx is preparing for multi-dimensional expansion to reach more patients through a rich pipeline of differentiated assets, led by VYVGART, our first-in-class neonatal Fc receptor blocker approved for the treatment of gMG, and with the potential to...

About usAt Ardena, 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.As a global Contract Development and Manufacturing Organization (CDMO) and Contract Research Organization (CRO), Ardena partners with pharmaceutical and biotech...

Johnson & Johnson Innovative Medicine is recruiting for a Senior Principal Scientist, CMC Regulatory Affairs - Combination Products. This hybrid role can be located in Beerse, Belgium or Warsaw, Poland, and leads complex regulatory strategies across global programs.You will provide expert interpretation of regulatory requirements for drug-device combination...

Jobtoolz in Kortrijk, Belgium is seeking a CMC Lead to drive molecule development in the CMC space. You will design experiments, interpret data and prepare technical reports while coordinating with scientists and customers.The role emphasizes robust documentation, strategic input and timely project delivery in a dynamic biotech setting. We expect a Life...

About usAt Ardena, 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.As a global Contract Development and Manufacturing Organization (CDMO) and Contract Research Organization (CRO), Ardena partners with pharmaceutical and biotech...

UCB, a global biopharmaceutical company, invites applications for a role within the CMC Development Sciences – Excellence & Operations department. The mission focuses on mapping and modelling development processes, defining roles, and promoting BPM best practices to streamline operations.The ideal candidate holds a Master’s degree in a related field and...

CMC Statistician (Biologics Early Development) Location: Braine-l’Alleud, Belgium (Hybrid – min. 40% on-site) Start Date: February 2026 (Minimum 1-year duration) We are seeking a skilled CMC Statistician to join a growing team within a leading biopharmaceutical company based in Braine-l’Alleud. Due to increased workload across both development and...

argenx is seeking a senior CMC leader to shape the development plan for multiple assets, ensuring alignment with clinical strategy and supply planning. You will lead a CMC team, collaborate with AST, and drive end-to-end program execution across drug substance and drug product realms.The role requires an advanced life sciences degree with 10+ years in CMC,...

Location: Braine‑l’Alleud, Belgium Engagement Status: Freelance position until December 2026 (extension possible) Overview We are partnered with a leading global biopharmaceutical organisation and who seeking someone to support the digital transformation of CMC development laboratories, focusing on ELN development, system integrations, and cloud...

Alsinova is seeking a Technical Regulatory Writer (CMC) to join our regulatory team in Belgium. The role focuses on technical writing for facilities and equipment for global regulatory submissions, coordinating with SMEs and QA/production to ensure timely completion.Ideal candidates have a Life Sciences background and at least 3 years of CMC writing...

UCB is seeking a DT Lead for Single Systems within the CMC Development Sciences landscape in Belgium. You will own a portfolio of Industrial Single Systems, ensuring secure, compliant operation and alignment with DT roadmaps. You will collaborate with scientists, stakeholders, and vendors to design, validate, and deploy solutions, while driving lifecycle...

Pauwels Consulting seeks an expert to lead regulatory dossier assessments and gap analyses for EU submissions, aligning with ICH and CMC requirements. You will identify risks, develop justifications, and shape remediation plans to support health authority responses. The role demands 8+ years in pharma or life sciences, strong technical writing and...

Johnson & Johnson is recruiting for a Senior Principal Scientist, CMC Regulatory Affairs - Combination Products. The role is hybrid and can be located in Beerse, Belgium or Warsaw, Poland. You will lead regulatory strategies for complex combination products and provide expert guidance across global regulatory requirements and Health Authority interactions....

UCB is seeking a DT Lead for Single Systems within the CMC Development Sciences landscape in Belgium. You will own a portfolio of Industrial Single Systems, ensuring secure, compliant operation and alignment with DT roadmaps.You will collaborate with scientists, stakeholders, and vendors to design, validate, and deploy solutions, while driving lifecycle...

Pauwels Consulting seeks an expert to lead regulatory dossier assessments and gap analyses for EU submissions, aligning with ICH and CMC requirements. You will identify risks, develop justifications, and shape remediation plans to support health authority responses.The role demands 8+ years in pharma or life sciences, strong technical writing and stakeholder...

Alsinova is seeking a Technical Regulatory CMC Writer based in Belgium to join our consulting team for pharma and biotech clients. You will handle technical writing for facilities and equipment across global regulatory files, coordinating with SMEs and QA teams to ensure timely submissions.Requires 3+ years in CMC writing, knowledge of regulatory guidelines,...

Description Sr Regulatory Consultant (CMC, EU mkt) (Office based) Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate...

What we will accomplish together: Alsinova is looking on a regular basis for Technical Regulatory CMC Writers to join our consulting team for clients’ projects (from big pharma to small biotech) based in Belgium. Your mission (should you decide to accept it): Your potential challenges will be various, depending on the clients’ priorities. The list below...

UCB is an international biopharmaceutical company primarily engaged in the research, development, and commercialization of pharmaceutical and biotechnological products. It specializes in researching therapeutic solutions for patients suffering from severe diseases, treated by specialists, particularly in the fields of the central nervous system (including...