- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- …of the associated regulatory challenges to the GRL, global regulatory team, assigned project teams, and internal/external functional business units ... associated regulatory challenges to the GRL, global regulatory team, assigned project teams, and internal/external...needed. - Works collaboratively with members of the global regulatory team (GRL, regional leads, CMC -RA, labeling,… more
- BD (Becton, Dickinson and Company) (Warwick, RI)
- …not limited to healthcare antiseptic products. Under the mentorship of the Sr. RA Manager of Regulatory Affairs, they are responsible for the development of ... the regulatory requirements and support the proposed product claims. + Review CMC changes and determine regulatory reporting category in accordance with FDA… more
- Boehringer Ingelheim (Duluth, GA)
- …stakeholders will vary from USA GI Region, USA CMC , Corporate Affairs or regulatory agencies. + In partnership with RA project team members, helps drives ... initiatives to achieve USA priorities for RA and USA CMC objectives. This role is directly responsible for improving...and responsible for supporting RA leader by reflecting the regulatory submission timing needed for project program.… 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. ... and timely decision-making. + Represent Biologics Product Sciences on cross-functional CMC and project teams and collaborate closely with Pharmaceutical… more
- ThermoFisher Scientific (Greenville, NC)
- …+ Capable of working independently and exercising independent judgment to assess sponsor regulatory needs and work with project team members to producing ... of ICH and other global regulatory guidelines; in-depth understanding of a regulatory specialty areas, such as preclinical, clinical, CMC , publishing, etc. +… more
- ThermoFisher Scientific (Greenville, NC)
- …+ Capable of working independently and exercising independent judgment to assess sponsor regulatory needs and work with project team members to producing ... depend on - now and in the future. Our Project Delivery colleagues within our PPD(R) clinical research services...global regulatory guidelines; in-depth understanding of a regulatory specialty areas, such as preclinical, clinical, CMC… more
- ThermoFisher Scientific (Wilmington, NC)
- …consent templates and other protocol specific documents as required. Collaborates with the project manager to prepare, organize, and present at client meetings, ... members involved in the study set up (DM, Reg, CMC etc ): ensure feasibility report are exhaustive, Review...activity timelines and metrics, providing status updates to the project manager , regularly reviewing projects using tracking… more
- Amgen (Thousand Oaks, CA)
- …partners such as Drug Substance Technologies, Drug Product Technologies, Product Quality, Regulatory CMC , and Supply Chain. The successful candidate will ... improvements, and support method and validation and transfers + Contribute to global regulatory filings by authoring analytical CMC sections and RTQs ensuring… more
- Otsuka America Pharmaceutical Inc. (Baton Rouge, LA)
- … regulatory submissions for OPDC R&D products. Performs quality reviews of CMC sections of regulatory submissions. + Authors and maintains Standard Operating ... The Senior Manager , Global Product Quality - Biologics is responsible...Subsidiaries ensure Compliance with local and global requirements and regulatory requirements. + Interfaces with project teams… more
- ICON Clinical Research (Blue Bell, PA)
- …medical monitors, as well as staff from quality, clinical compliance, regulatory , formulations, and IOPS ( CMC , external manufacturing, stability). Vendor ... Clinical Drug Supply Manager ICON plc is a world-leading healthcare intelligence...needed. Supports inspection team in preparation for and during regulatory agency inspection. Study Team Interaction + Represents Clinical… more