Regulatory Affairs- Manager-CMC - Somerset

· Overview · Lupin is comprised of a fast growing, innovative and robust team of manufacturing, Research and Development and commercial divisions. Together these entities make up the generic and branded U.S. business. Lupin has a significant generic pipeline, and a branded focus ...

Responsible for developing and implementing CMC regulatory strategies for assigned pharmaceutical products in accordance with global regulations and guidances. · ...

The CMC Regulatory Affairs Specialist will be responsible for developing and implementing regulatory strategies for assigned pharmaceutical products in accordance with global regulations and guidances. · ...

Serve as the CMC Product Lead for assigned products and be accountable for the delivery of all regulatory milestones for assigned products through the product lifecycle. · ...

This role involves developing regulatory strategies for pharmaceutical products in accordance with global regulations. Key responsibilities include leading CMC dossier preparation for life-cycle changes to commercial products and collaborating with clients on regulatory complianc ...

Taiho Oncology is on a mission: to improve the lives of patients with cancer, their families and caregivers. · ...

This position will coordinate activities with all functional departments in support of regulatory filings. Manage assigned projects to ensure thoroughness, accuracy, and timeliness of CMC dossiers and responses. · ...

We are hiring CMC Regulatory Affairs (CMC-3) for one of our clients. Responsible for developing and implementing CMC regulatory strategies for assigned pharmaceutical products in accordance with global regulations and guidance. · ...

We are seeking a Technical Project Manager III (CMC Regulatory Affairs) to join our team in Short Hills, NJ. · This role will be responsible for developing and implementing CMC regulatory strategies for assigned pharmaceutical products. · ...

About Acadia Pharmaceuticals · Acadia is committed to turning scientific promise into meaningful innovation that makes the difference for underserved neurological and rare disease communities around the world. Our commercial portfolio includes the first and only FDA-approved trea ...

Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogen ...

Legend Biotech es una empresa biotecnológica global dedicada al tratamiento y cura potencialmente futura de enfermedades letales. · ...

Legend Biotech is seeking an Associate Director, CMC Project Management as part of the Technical Development team based in Somerset NJ. · Ensure that projects/deliverables adhere to program and business goals by developing and driving project plans capturing assumptions managing ...

Legend Biotech entered into a global collaboration agreement with Janssen to jointly develop and commercialize ciltacabtagene autolecuel. We are seeking an Associate Director, CMC Project Management based in Somerset NJ. · Ensure that projects/deliverables adhere to program and b ...

We are seeking a Global Regulatory CMC Manager to participate in the development of the CMC regulatory strategy for small molecules, biologics and cell therapy submissions. · Experience with CMC regulatory documents (IND/CTAs, BLA/NDAs, MAAs) · Knowledge of FDA, EMA and/or ICH gu ...

The mission of HUTCHMED International Regulatory Affairs is to develop innovative global registration strategies that advance our pipeline through approval in US, EU, and other countries. · Lead CMC regulatory strategy development and implementation that incorporates risk identif ...

Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogen ...

· Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allo ...

This role is based out of New Brunswick, NJ. The person will serve both the New Brunswick and Summit locations.The Senior CMC Project Manager is closely partnered with the CMC Team Leader to enable effective development and execution of integrated CMC strategy and plans. · ...

Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogen ...