- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- …strategic planning of regulatory interactions and Provides tables and listings for FDA meeting briefing packages. + Support statistical needs for market access and ... Regulatory Affairs regarding study design and complex analysis issues, FDA issues, and general drug development. + Reviews clinical,...be applied on his/her assigned therapeutic area. + Attend FDA meetings, FDA advisory boards, or other… more
- ITG Brands (NC)
- …strategies for PMTA and other regulatory submissions, ensuring alignment with FDA expectations and public health standards. Oversee and conduct human health ... a regulatory-facing subject matter expert, representing the company in FDA meetings, scientific conferences, and industry forums. Collaborate cross-functionally with… more
- ITG Brands (NC)
- …and nicotine products. The ideal candidate will bring deep expertise in FDA regulation, multi-state compliance, and regulatory litigation, with the ability to ... and nicotine products. Serve as a strategic legal advisor on FDA regulatory matters, including product submissions, labeling, marketing, enforcement, and reporting.… more
- United Therapeutics (Research Triangle Park, NC)
- …pulmonary arterial hypertension ( **PAH** ). Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung ... of education and experience + 15+ years of experience in an FDA regulated pharmaceutical manufacturing environment, with emphasis on SAP, Laboratory Information… more
- Oracle (Raleigh, NC)
- …Clinical Evaluation Reports (CERs), including alignment with EU MDR and FDA regulatory requirements. . Oversee usability engineering (IEC 62366), ensuring ... Knowledge of ISO 14971, IEC 62366, EU MDR/IVDR, and FDA guidance related to medical device software (SaMD). ..... Experience supporting regulatory submissions or audits (EU MDR, FDA 510(k), etc.). . Experience working with AI-driven medical… more
- Chiesi (Cary, NC)
- …This intern will ensure Chiesi's products are produced and tested under fully FDA compliant systems and processes. This role is instrumental in supporting the ... product portfolio in compliance with technical requirements from existing and new FDA regulations, in accordance with CGMP principles. + Use of statistical… more
- Oracle (Raleigh, NC)
- …Health is transforming its development and regulatory processes to meet heightened FDA , MDR, and ISO 14155 standards and address ongoing patient safety, compliance, ... or regulated healthcare software sectors. . Extensive experience in FDA , MDR, and ISO 14155 compliance, clinical risk management,...with product lifecycle activities. . Ensure clinical compliance with FDA , MDR, and ISO 14155, acting as the central… more
- United Therapeutics (Morrisville, NC)
- …their daughter's pulmonary arterial hypertension (PAH). Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial ... essential services that streamline patient access to therapy. Compliantly adhering to FDA and other regulatory guidelines, the Patient Navigator takes ownership of… more
- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- …products and drug-device combination products. Ensure compliance with global regulations ( FDA , EMA, ICH, WHO) and anticipate regulatory changes impacting CMC ... for investigational, marketed product submissions (IND/IMPD/NDA/MAA/DMF, post-approval supplements) for FDA and equivalent submissions for Europe and Canada. +… more
- Oracle (Raleigh, NC)
- …applying medical device standards (including IEC 62304, IEC 82304, and FDA guidance), define software interfaces, manage traceability across the system lifecycle, ... device software, ensuring vulnerability management and cybersecurity compliance with FDA and global regulatory expectations. + Apply the organization's Risk-Based… more