- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- …or continued marketing. **Job Description** + Develop and implement global CMC regulatory strategies for late-stage development, marketing applications (eg, ... of regulatory submissions (IND/IMPD/NDA/MAA, post-approval supplements). Determine regulatory CMC content and scientific/technical requirements to ensure… more
- Merck (Raleigh, NC)
- …development through commercialization, with practical insight into how these operations generate CMC regulatory content + Understanding of CMC operations, ... source systems to regulatory documentation. Under the guidance of dCMC Regulatory Authoring Leadership, the Senior Specialist, Regulatory Authoring… more
- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- …business units as needed. - Works collaboratively with members of the global regulatory team (GRL, regional leads, CMC -RA, labeling, medical writing, ... **Position Summary** Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed prescription… more
- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- The Senior Manager , Global Product Quality - Biologics is responsible for managing quality oversight of clinical and commercial products at CMOs under contract ... submissions for OPDC R&D products. Performs quality reviews of CMC sections of regulatory submissions. + Authors...of combined experience in pharmaceutical/medical device industry as a manager in Manufacturing, QA or QC role supporting GMP… more
- ThermoFisher Scientific (Wilmington, NC)
- …people and communities depend on - now and in the future. **Role:** CTM, Senior **Location:** US-Remote, East Coast HIGHLY preferred, may look at Central, but will ... complexity, and may assume regional lead or Clinical Study Manager responsibilities. **Key Responsibilities** : + Manages all clinical...members involved in the study set up (DM, Reg, CMC etc ): ensure feasibility report are exhaustive, Review… more
- ThermoFisher Scientific (Morrisville, NC)
- …experience in Pharmaceutical Industry, including Manufacturing, Quality Control, Quality Assurance, CMC , Regulatory or related compliance experience with at ... in the mission to holistically assess the state of quality and regulatory compliance across PSG global manufacturing/testing sites via fully independent audit… more
- ThermoFisher Scientific (Greenville, NC)
- …of ICH and other global regulatory guidelines; in-depth understanding of a regulatory specialty areas, such as preclinical, clinical, CMC , publishing, etc. + ... **Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office **Job Description** ** Senior Director Project Mgmt - Oversight** At Thermo Fisher… more
- ThermoFisher Scientific (Greenville, NC)
- …of ICH and other global regulatory guidelines; in-depth understanding of a regulatory specialty areas, such as preclinical, clinical, CMC , publishing, etc. + ... cross-cultural experience. **Discover Impactful Work:** We are seeking a ** Senior Director, Project Management** in our **Oversight Respiratory Trials Team.**… more