- 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)
- …advanced degree may count toward years of experience. + Direct experience with FDA regulatory submissions required. + Experience with regulatory submissions ... information, please visit grail.com . The role assists with regulatory strategy and the development of submissions in partnership...and activities to optimally position GRAIL products with the FDA and/or global health authorities. + Support the US… more
- ITG Brands (NC)
- …the development and submission of Premarket Tobacco Product Applications (PMTAs) and other regulatory filings to the FDA Center for Tobacco Products (CTP). The ... a relevant scientific discipline and possess deep expertise in regulatory strategy, toxicology, clinical studies, and FDA ...in regulatory strategy, toxicology, clinical studies, and FDA engagement. - WHAT YOU WILL DO + Lead… 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 ... + Prior technical writing experience and proven track record with FDA and EU regulatory submissions. + Excellent interpersonal skills. + Ability to work… more
- ITG Brands (NC)
- …evolving FDA guidance and behavioral science methodologies to inform regulatory strategy and study design. Provide expert consultation to internal teams on ... leadership in designing and managing studies that address complex behavioral and regulatory questions. Direct experience with FDA 's regulatory framework,… more
- Grifols Shared Services North America, Inc (Clayton, NC)
- … submissions **Knowledge, Skills, & Abilities:** Comprehensive knowledge and understanding of FDA and global regulatory requirements for the biotechnology and ... services in more than 110 countries and regions. **Summary:** Leads the R&D Regulatory Strategy group for assigned products in managing regulatory programs in… more
- ITG Brands (NC)
- …hold these certifications should be willing to obtain them. In-depth knowledge of FDA regulatory pathways, especially PMTA and SE submissions. Proven ability to ... WILL DO Lead the development of toxicology strategies for PMTA and other regulatory submissions, ensuring alignment with FDA expectations and public health… more
- Sumitomo Pharma (Raleigh, NC)
- …clinical regulatory strategies including management of IND and NDA submissions, FDA and other global regulatory interactions, as well as international ... to support proposed claims and assess consistency of proposed claims with FDA -approved labeling + Provide regulatory leadership to the respective… more
- Oracle (Raleigh, NC)
- …for Clinical Evaluation Reports (CERs), including alignment with EU MDR and FDA regulatory requirements. . Oversee usability engineering (IEC 62366), ensuring ... Excellent cross-functional communication and documentation skills. Preferred: . Experience supporting regulatory submissions or audits (EU MDR, FDA 510(k),… more
- Oracle (Raleigh, NC)
- …for Clinical Evaluation Reports (CERs), including alignment with EU MDR and FDA regulatory requirements. . Oversee usability engineering (IEC 62366), ensuring ... Excellent cross-functional communication and documentation skills. Preferred: . Experience supporting regulatory submissions or audits (EU MDR, FDA 510(k),… more