- Glenmark Pharmaceuticals Inc., USA (Monroe, NC)
- …(Functional / Technical): + Strong understanding of current GMPs and related regulatory health authority guidance ( FDA regulations, ICH guidelines, etc.) related ... investigated, and resolved according to established deadlines and company and regulatory requirements. + Coordinates with cross-functional teams for testing of… more
- Novo Nordisk (Charlotte, NC)
- …within the organization. From healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups… more
- Fujifilm (Research Triangle Park, NC)
- …and operations for GMP systems (MES, LIMS, ERP, automation platforms, etc.) meet regulatory and compliance requirements ( FDA , EMA, MHRA, etc.). + Oversee ... with Quality, Compliance, and other technology leaders to maintain GMP and regulatory standards across global manufacturing sites. With a team of approximately 80+… more
- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- …planning of regulatory interactions and Provides tables and listings for FDA meeting briefing packages. + Support statistical needs for market access and ... statistical expertise/input in the drug development including clinical development plan and regulatory submission strategy. This is a strategic and critical role in… more
- Glenmark Pharmaceuticals Inc., USA (Monroe, NC)
- …Knowledge and Skills: + Strong understanding of current GMPs and related regulatory health authority guidance ( FDA regulations, ICH guidelines, etc.) as ... triaged, investigated, and resolved according to established deadlines, company and regulatory requirements. + Coordinates with cross-functional teams for testing of… more
- BrightSpring Health Services (Asheville, NC)
- …of practice + Knowledge of drug therapy guidelines, medication safety practices, and regulatory standards (CMS, DEA, FDA ). + Proficiency in electronic medical ... medications and biologicals. + Ensure compliance with all state and federal regulatory requirements related to pharmacy practice and medication management. + Report… 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 ... Control, Quality Event, and CAPA programs and supporting management during regulatory agency(ies) inspections, third-party partners, and customer audits. + Work… more
- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- …and managing cross-functional teams. + Strong understanding of R&D functions and the regulatory landscape (GxP, ICH, FDA , EMA, etc.). + Proven ability to ... design and deliver impactful learning programs using adult learning principles. + Experience with learning technologies (eg, LMS, virtual learning platforms) and data-driven training strategies. + Excellent communication, collaboration, and stakeholder… more
- Jabil (Asheville, NC)
- …in ensuring that the site's Quality Management System (QMS) aligns with regulatory standards and supports medical manufacturing excellence. You will lead initiatives ... to maintain compliance with ISO 13485:2016, FDA 21 CFR Part 820, and 21 CFR Part...business opportunities. Your work will directly impact product quality, regulatory readiness, and operational efficiency-requiring exceptional attention to detail,… more
- Datavant (Raleigh, NC)
- …Connect** and **Aetion Evidence Platform** . These platforms deliver regulatory -grade real-world data (RWD) solutions through tokenization, data linkage, and ... Customer Assurance to ensure that we meet or exceed regulatory expectations and customer trust standards. This role is...all quality activities, systems, and changes in compliance with FDA 21 CFR Part 11 and ICH E6(R3). +… more