- Sumitomo Pharma (Raleigh, NC)
- …clinical regulatory strategies including management of IND and NDA submissions, FDA and other global regulatory interactions, as well as international ... the quality and scientific integrity of documents submitted to regulatory authorities + In collaboration with Commercial, Medical and Legal colleagues, conduct… more
- Dentsply Sirona (Charlotte, NC)
- …device industry. + Experience with leading regulatory submissions and managing regulatory projects. + In-depth knowledge of FDA 510(k) and international ... communication skills. + Prior technical writing experience and proven track record with FDA and EU regulatory submissions. + Excellent interpersonal skills. +… more
- University of North Carolina- Chapel Hill (Chapel Hill, NC)
- …work location is subject to change based on the unit's business needs. The Quality Assurance & Regulatory Specialist will be responsible for supporting Research ... implementing, and maintaining quality assurance processes. The Quality Assurance & Regulatory Specialist plays a...Practice ( GCP ), Food and Drug Administration ( FDA ) regulations and International Conference on Harmonization (… more
- Chiesi (Cary, NC)
- …regulatory affairs, FDA regulations, or drug development. + Familiarity with FDA regulatory pathways (eg, IND, NDA, BLA, orphan drug designation). + ... responses to FDA information requests). + Conducting background research on FDA regulations, guidance, and regulatory precedents relevant to rare diseases… more
- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- …drug products and drug-device combination products. Ensure compliance with global regulations ( FDA , EMA, ICH, WHO) and anticipate regulatory changes impacting ... as CMC regulatory lead on global project teams (Pharmaceutical Development, Quality , Manufacturing, Global Regulatory Strategy). + Assess and provide … more
- ITG Brands (NC)
- …tobacco and nicotine products. Serve as a strategic legal advisor on FDA regulatory matters, including product submissions, labeling, marketing, enforcement, and ... regulatory industry (tobacco, pharmaceuticals, medical devices). + Strong background in FDA regulatory matters, state- regulatory compliance, regulatory… more
- GRAIL (Durham, NC)
- …Regulatory affairs and IVD device experience required. + Direct experience with FDA regulatory submissions required. + Demonstrated knowledge of US and ... Quality , Lab Operations, and other stakeholders to support regulatory strategy development, product validation, audits, promotional material review, on-market… more
- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- **Position Summary** Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed prescription ... activities for all assigned projects in alignment with the Global Regulatory Lead. Translates complex pertinent global requirements and provides an assessment… more
- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- …Review overall quality of ad hoc query research for requested regulatory topics and confirm acceptability of responses. + Demonstrate understanding of the major ... affairs experience. + Minimum 2-3 years' work experience in regulatory intelligence. + Previous interactions with FDA ...in regulatory intelligence. + Previous interactions with FDA or other health authority are desirable. **Skills and… more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …more than 110 countries and regions. **Summary:** Implement worldwide regulatory product registration strategies, prepare complex registration dossiers, establish ... on labeling, labeling requirements, and implementation. Coordinate and submit all regulatory documentation for establishment of new / changed local market… more
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