Drug Regulatory Affairs Jobs

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Associate Director Regulatory Affairs  

Life Science People - South San Francisco, CA, United States

for genetically defined neurological and immunological diseases, are looking for an Associate Director, Regulatory Affairs to join their team. Leveraging recent advancements in human genetics alongside drug

from: linkedin.com - 2 days ago

Director, Drug Safety Operations  

GQR - , CA, United States

, Medical Affairs, Regulatory Affairs) for safety data collection and handling. Liaise with Drug Safety vendors and partners to meet global regulatory requirements for SAE reporting. Develop/update SOPs

from: linkedin.com - 2 days ago

Postdoctoral Associate- Genome Editing for Cell Therapy  

Baylor College of Medicine - US

approach. Collaborates with principal investigators, regulatory affairs specialists, and medical writers to ensure accuracy, compliance, and adherence to deadlines. Contributes to the development

from: Baylor College of Medicine - Yesterday

Senior Director/Director, Global Regulatory Affairs Lead (remote)  

Corbus Pharmaceuticals - Norwood, MA, United States

in Regulatory Affairs Experience in all types of regulatory submissions including but not limited to INDs, NDAs, MAA, Type A-D Meetings with FDA, Scientific Advice Consultations with the CHMP of EMA and MHRA, MAA

from: linkedin.com - 2 days ago

Sr. Director of Regulatory Affairs - Oncology  

Mantell Associates - Boston, MA, United States

sciences or a related field Minimum of 6 years of regulatory affairs experience in the biopharmaceutical industry, with a focus on rare diseases/oncology and orphan drug development Proven track record

from: linkedin.com - 2 days ago

Director, Regulatory CMC  

Editas Medicine - Cambridge, Massachusetts

and advanced degree preferred with a minimum of 10 years’ experience in drug development/regulatory affairs and a minimum 8 years in CMC regulatory affairs. Experience with both US FDA and EMA with drugs

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from: resume-library.com - 2 days ago

Senior Scientist  

Meet - Ridgefield, CT, United States

. Specializations can include: Medicinal Chemist, Pharmacologists, Toxicologists, Clinical Pharmacologist, Formulation Scientists, Microbiologists, Biotechnologists, Bioinformatics Specialist, Regulatory Affairs

from: linkedin.com - 2 days ago

Sr. Director Regulatory Affairs  

EPM Scientific - San Diego, CA, United States

, as required. Qualifications: 8+ years of Clinical Regulatory Affairs experience in drug development. Hands on experience with INDs, CTA, BLAs, Etc. Experience with regulatory submissions in the biotech

from: linkedin.com - 9 days ago

AD, Downstream Process Development  

Lassen Therapeutics - United States

and communicate plans at project team meetings. * Lead troubleshooting and investigation of critical deviations. * Support the selection of CDMOs. * Collaborate with QA, Regulatory Affairs, and other functions

from: jobrxiv.org - Yesterday

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Director, Non-Clinical Toxicology  

MapLight Therapeutics, Inc. - Burlington, MA, United States

Collaborate with CMC, Program & Portfolio Management, Clinical, and Regulatory Affairs to develop program-specific strategies for appropriate data generation in support of development candidate nomination, IND

from: linkedin.com - 7 days ago

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