cmc

# CMC LeadKortrijkWe are a privately-owned European center of excellence for analytical solutions. For over 35 years we have been supporting our customers in various industries with our scientific know-how and technical expertise.https://ric-group.com/apply now### THIS IS YOU* **#yeswecan #winningteam #captainclarity #organizationguru*** **Science** lover,...

CMC Project Manager At ICON Strategic Solutions, you will work in a sponsor-dedicated model, supported by ICON’s global expertise. As the world’s largest FSP organisation, with over 90 sponsor partnerships, we offer stability, career development and a collaborative environment where your work contributes to the development of treatments that benefit...

PURPOSE OF THE FUNCTION • Build the CMC Development plan in collaboration with the CMC Development team, ensuring alignment with the clinical development plan and clinical trial supply strategy • Define long-term CMC strategy for specific assets or projects in line with the Target Product Profile (TPP) • Provide leadership and facilitate communication...

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...

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...

argenx SE is seeking a senior leader to shape the CMC development plan and strategy for multiple drug programs. You will align CMC with clinical and trial supply plans, lead the CMC Development team, and drive end-to-end oversight across drug substance, drug product, analytics, and regulatory activities.You will coordinate with Asset Strategy Teams and...

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...

Job Description & Summary Contribute to creating a better tomorrow The only way we can tackle the challenges of this fast-changing world is with passionate people. Led by our purpose of building trust and solving important problems, we come together at PwC to address the biggest issues facing the world in a way that drives positive impact. Are you eager to...

GSK Vaccines is seeking a regulatory-focused professional to lead global CMC regulatory activities across development stages, including strategy development for IND/IMPD through NDA/MAA. You will collaborate with regulatory, development and manufacturing teams to ensure timely submissions and lifecycle management while maintaining high standards. The role...

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...

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...

PURPOSE OF THE FUNCTIONResponsible for providing Regulatory CMC expertise into the development and implementation of the global regulatory strategy, operations and planning for the CMC aspects of assigned projects/products. Responsibilities include developing and implementing regulatory strategies, authoring / reviewing of quality submission packages,...

Syneos Health is seeking a Sr Regulatory Consultant (CMC, EU mkt) for an office-based role in India. The incumbent will lead regulatory submissions, including Module 3 CMC sections, for INDs and post-approval variations, with strong EU market experience, up to 25% travel, and potential line management of a small team depending on location.The role requires...

argenx is seeking a Regulatory CMC expert to lead global regulatory strategy for large molecule programs, from pre-clinical through commercial stages, in a rapidly expanding biotech environment.You will author and review regulatory submissions, coordinate with internal teams and external partners, and ensure timely delivery while aligning with ICH, FDA, EMA...

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...

Delivering breakthrough therapies for stroke patients by developing an innovative pipeline in thrombo-inflammation.We are seeking a part-time CMC Consultant / Junior Project Manager to support the execution and coordination of development activities within a fast-growing biotech environment. This position combines scientific oversight and operational project...

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...

GSK Vaccines is seeking a regulatory-focused professional to lead global CMC regulatory activities across development stages, including strategy development for IND/IMPD through NDA/MAA. You will collaborate with regulatory, development and manufacturing teams to ensure timely submissions and lifecycle management while maintaining high standards.The role...

Johnson & Johnson Innovative Medicine in Beerse, Belgium, or Warsaw, Poland, seeks a Senior Principal Scientist, CMC Regulatory Affairs - Combination Products. Hybrid role requiring leadership of regulatory strategies across drug-device combinations and global submissions. You will mentor cross-functional teams, guide Health Authority interactions, and shape...

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...