- Gilead Sciences, Inc. (Foster City, CA)
- …Join Gilead and help create possible, together. **Job Description** **Responsibilities** + The Regulatory Affairs CMC Senior Manager at Gilead is responsible for ... with colleagues across the global RA CMC organization, Gilead regulatory affairs , and affiliates on internal meetings and Health Authority interactions.… 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
- Otsuka America Pharmaceutical Inc. (Albany, NY)
- …issues. + Knowledge of CMC regulatory requirements for biologics and small molecules during development and post-approval, including biologic upstream and ... Provide CMC regulatory strategy input and expertise in the area...the area of investigational, new and marketed biologic and small molecule drug products to assigned project teams, to… more
- System One (Park Ridge, NJ)
- …lead and drive the technical (CMC) writing to accelerate the development of small molecules , combination drug/device products, and other innovative materials for ... + Works closely with clinical development teams, including clinical scientists, clinical affairs , regulatory affairs , biostatistics, physicians, and medical … more
- BeiGene (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
- The US Pharmacopeial Convention (USP) (Rockville, MD)
- …This role will be responsible for delivering USP monograph donations for small molecules , complex generics, biologics, and excipients through effective and ... donors to include, but not limited to the C-suite, Regulatory Affairs , Quality and R & D...staff). * Develops an overall understanding of USP's business ( Small Molecules , Biologics, Growth Programs) to ensure… more
- Takeda Pharmaceuticals (Lexington, MA)
- …Manufacturing Science & Technology (API MST) department provides technical solution to support Small Molecules and Oncology Operating Unit (SMO OpU). This is a ... individuals from Product Strategy, Quality, Compliance, External Supply Management, PS, GMSci, Regulatory Affairs and SMO OpU. * Interact externally in person… more
- AbbVie (North Chicago, IL)
- …developing scalable processes to make drug substances and drug products, including small molecules , peptides, and antibody drug conjugates (ADCs), throughout ... engineers, pilot plant engineers, drug product development scientists, program managers, and regulatory affairs specialists. + Author publications and present at… more
- Kelly Services (Bothell, WA)
- …audits are conducted according to timelines. * Collaborate with Clinical Operations, Regulatory Affairs , and other key stakeholders to provide clinical program ... conducting audits of clinical operations and vendors. * Experience with biologics and/or small molecules , biologics preferred. * Deep knowledge of GLP, GCP, GVP,… more