- Takeda Pharmaceuticals (Boston, MA)
- …therapies to patients worldwide. Join Takeda as an Associate Director, GRA CMC Small Molecules where you will oversee the development and execution of ... Proactively recognizes and contributes to enhancing business processes. As part of the Global Regulatory Affairs CMC team, you will report to the Senior Director… more
- Lilly (Indianapolis, IN)
- …need them all over the world. The Senior Advisor/Director in Global Regulatory Affairs - CMC Pre-approval Small Molecules will leverage CMC technical ... marketing authorizations for the synthetic molecule portfolio, including small molecules , peptides, and oligonucleotides. The regulatory scientist will be… more
- Kelly Services (Chesterfield, MO)
- …is part of a cross-functional project that integrates Plant Biotechnology, Small Molecules , and Regulatory Affairs . **Position Summary:** We are seeking ... a research specialist to perform studies in plant transformation, including preparation and analysis of protoplasts, nanoparticle encapsulation, uptake & translocation in int protoplast and plant, as well as ribonucleoparticle design and preparation.… more
- Ascendis Pharma (Palo Alto, CA)
- …we're advancing programs in Endocrinology Rare Disease and Oncology. The Sr. Director, Regulatory Affairs will serve as the therapeutic area head for assigned ... devastating diseases. This position will report to the VP, Regulatory Affairs and ideally be based in...the pharmaceutical or biotechnology industry with focus on biologics, small molecules , or synthetic peptides + Strong… more
- Lilly (Indianapolis, IN)
- …need them all over the world. The Advisor Post approval scientist in Global Regulatory Affairs - CMC Commercial Products will leverage CMC technical knowledge ... molecule drug substance CMC science and manufacturing processes for conventional small molecules and/or synthetic peptides, proteins or oligonucleotide. +… more
- Takeda Pharmaceuticals (Boston, MA)
- …Team to develop the regulatory framework for the clinical development of small molecules and biologic products leading to global marketing authorizations. + ... order to bring life-changing therapies to patients worldwide. The Senior Global Regulatory Affairs , Neuroscience is responsible for developing innovative global … more
- Amneal Pharmaceuticals (Piscataway, NJ)
- …global CMC and clinical regulatory strategies for Biologics, Biosimilars, and Small Molecules .Ensure alignment with regulatory trends, innovation, and ... + Develop and Execute Global Regulatory Strategies: Formulate and lead...Activities: Oversee submission planning, authoring, reviewing, and coordination for regulatory filings (eg, BLA, MAA). Identify required documentation and… more
- BeOne Medicines (San Mateo, CA)
- …or more major geographic areas, and prior experience with both small molecules and biologics. Has sufficient regulatory knowledge to integrate inputs from ... are met while leveraging expedited pathways where appropriate. The individual has regulatory affairs departmental and cross functional influence and acts as… more
- Boehringer Ingelheim (Ridgefield, CT)
- …portfolio of projects in multiple therapeutic areas and modalities including small molecules , monoclonal antibody-based biotherapeutics, viral, and gene ... Drug Metabolism & Pharmacokinetics, Translational Medicine & Clinical Pharmacology, CMC, Regulatory Affairs , Patient Safety and Pharmacovigilance to implement… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- …related therapeutic area clinical development, including experience with parenterally administered small molecules and biopharmaceuticals. REGN expects a total ... medical expert and leader in interactions with external collaborators (eg, regulatory authorities, key opinion leaders, advisory boards, patient advocacy groups),… more