- Parexel (Raleigh, NC)
- Bring your expert knowledge of FDA regulatory requirements and guidelines to Parexel! We are currently seeking a highly motivated Regulatory Affairs professional to ... join Parexel and contribute their knowledge of FDA regulatory requirements and processes to a major, dedicated client partnership. As a Senior Regulatory Affairs… 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 submissions. ... Commercial Regulatory Affairs function and serve as an internal expert on FDA regulations, guidance, and enforcement trends governing the advertising and promotion… more
- Dentsply Sirona (Charlotte, NC)
- …role manages and submits 510ks for the products and manages communications with FDA including pre-subs. The individual will also be responsible for mentoring and ... technical files for CE marking. + Manages communications with FDA and EU notified bodies on behalf of the...EU notified bodies on behalf of the company for FDA pre submissions, FDA 510(k) submissions and… 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 ... years of experience in quality assurance, quality engineering and management in the FDA regulated environment or a related industry with Bachelor's degree or 10+… more
- ThermoFisher Scientific (Wilmington, NC)
- …monitoring-are scientifically sound, risk-based, and compliant with global regulatory requirements ( FDA , EMA, WHO, PIC/S, and ICH Q7-Q10). The incumbent will serve ... that all validation strategies are science- and risk-based, in accordance with FDA Process Validation Guidance, Annex 15, and ICH principles, supporting PSG's… more
- Parexel (Raleigh, NC)
- …development. * Participate in promotional review committees, ensuring alignment with FDA regulations and company standards. * Collaborate with global teams to ... ensure consistency across markets while meeting US-specific requirements. * Maintain compliance with FDA 21 CFR Part 202 and other relevant US regulations. * Support… more
- ITG Brands (NC)
- …regulatory strategy, and cross-functional collaboration to ensure all behavioral data meets FDA standards for demonstrating that a product is "appropriate for the ... assessment of Next Generation Products (NGPs), ensuring data is compliant with FDA requirements. Design and oversee behavioral studies (eg, TPPI, Actual Use),… more
- Chiesi (Cary, NC)
- …documents and submissions (eg, INDs, BLAs/NDAs, supplements, amendments, and responses to FDA information requests). + Conducting background research on FDA ... have + Coursework or prior exposure to regulatory affairs, FDA regulations, or drug development. + Familiarity with ...FDA regulations, or drug development. + Familiarity with FDA regulatory pathways (eg, IND, NDA, BLA, orphan drug… more
- Grifols Shared Services North America, Inc (Research Triangle Park, NC)
- …centers in the United States consistently operate in full compliance with FDA and PPTA regulations, corporate quality standards, and industry best practices. The ... + **Compliance & Quality Oversight** + Ensure donor centers comply with US FDA , EMA, PPTA IQPP standards, CLIA/COLA, and state regulations. + Maintain audit and… more
- 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