- 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
- J&J Family of Companies (Spring House, PA)
- …and implementing robust North America regulatory strategy for both large and small molecules in the Immunology Therapeutic Area. + Leading and facilitating ... and profoundly impact health for humanity. Learn more at https://www.jnj.com **Job Function:** Regulatory Affairs Group **Job Sub** **Function:** Regulatory … 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
- BeiGene (San Mateo, CA)
- …are met while leveraging expedited pathways where appropriate. The individual has regulatory affairs departmental and cross-functional influence and acts as an ... candidates will have experience working as a lead in Regulatory Affairs across two or more major...more major geographic areas, and prior experience with both small molecules and biologics. + Thorough understanding… 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
- 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
- Sokol Materials & Services (Skillman, NJ)
- …principles. + Collaborate with Cross-Functional Teams + Work closely with R&D, Regulatory Affairs , Quality, and Manufacturing teams to align on document ... to support the timely submissions of both investigational and marketing applications for small and large molecules . This position requires the knowledge of… more