- Takeda Pharmaceuticals (Lexington, MA)
- …relevant industry forums and external regulatory dialogues. + Collaborate with Regulatory , Engineering, CMC , Safety, Commercial Quality, and Digital teams to ... for medical device and digital health technologies, ensuring compliance with international regulatory requirements and Takeda Global procedures. + Lead and develop a… more
- J&J Family of Companies (Spring House, PA)
- …+ Drive effective communication and cross‑functional collaboration with R/D Clinical, Regulatory , Pharmacokinetics, CMC , Quality Assurance, and Data Management ... precision, robustness, drug tolerance) and review associated reports according to regulatory expectations and departmental SOPs. + Lead troubleshooting and assay… more
- BeOne Medicines (Emeryville, CA)
- …and provide a high service level to internal stakeholders (eg Clinical Operations, Regulatory , Quality, CMC ). + Work with Clinical Operations to understand ... protocol(s). + Coordinate review and approval of labels with stakeholders (eg Regulatory , Clinical Operations, CRO) and CMOs. + Support IRT user acceptance testing,… more
- BeOne Medicines (San Mateo, CA)
- …and provide a high service level to internal stakeholders (eg Clinical Operations, Regulatory , Quality, CMC ). + Work with Clinical Operations to understand ... + May coordinate review and approval of labels with stakeholders (eg Regulatory , Clinical Operations, CRO) and CMOs. + Support IRT user acceptance testing,… more
- Surrozen (South San Francisco, CA)
- …write detailed technical reports; and assist in developing workflows to support CMC , business development activities, and regulatory filings. . Collaborate ... anti-drug antibody (ADA) assays, and pharmacokinetic (PK), potency assays to support CMC activities, as well as analyzing study samples. The ideal candidate will… more
- Takeda Pharmaceuticals (Boston, MA)
- …well versed in all stages of pharmaceutical development and understand the global regulatory trends for CMC activities, to proactively shape strategies and ... process characterization, and validation. + Strong understanding of the global regulatory environment and evolving expectations relation to CMC , process… more
- Takeda Pharmaceuticals (Lexington, MA)
- …or more products and provide strong technical expertise and leadership for regulatory interactions, including authoring CMC content for multi-site products. ... Through your deep product and process understanding you will shape CMC and program strategy and ensure robust control strategies to the benefit of patients… more
- Globus Medical, Inc. (Audubon, PA)
- …studies, analytical characterization, and process validation + In-depth understanding of CMC (Chemistry, Manufacturing, and Controls) regulatory considerations + ... technical reports, and ensures strict compliance with applicable quality and regulatory standards + Possesses in-depth knowledge of CBER (Center for Biologics… more
- Takeda Pharmaceuticals (Lexington, MA)
- …the biologics portfolio and provide technical expertise and leadership for regulatory interactions, including authoring CMC content for multi-site products. ... data, and drive data-based decisions and solutions. + Experience contributing to regulatory filings for biologics (eg, CMC sections, control strategy… more
- Kelly Services (Bristol, TN)
- …product configurations, and master data within LIMS and SAP. + Support CMC supplements, Annual Product Reviews, regulatory filings, and documentation for ... statistical evaluations, and prepare technical reports, risk assessments, and regulatory documentation. + Support process validation activities for **oral solid… more