- ThermoFisher Scientific (Wilmington, NC)
- **Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office **Job Description** Join Us as a Director Regulatory Affairs - Make an Impact at the ... Forefront of Innovation The Director Regulatory Affairs provides operational...written * Excellent understanding of global/regional/national country requirements and regulatory affairs procedures for clinical … more
- Sumitomo Pharma (Raleigh, NC)
- …a dynamic, highly motivated, and experienced individual for the position of **Associate Director , Regulatory Affairs (Oncology).** The Associate Director ... is part of the Global Regulatory Affairs (GRA) team based in the US. He/She will...to electronic regulatory submissions and working with regulatory templates + Understanding of EU Clinical … more
- GRAIL (Durham, NC)
- …**Required Qualifications:** + MS or PhD with 10+ years of experience in regulatory , development, clinical affairs , quality, or program management within ... Affairs Certification (RAC) preferred. + Experience in pharmaceutical clinical , statistical, or regulatory settings-especially in oncology, immunology, or… more
- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- As a senior leader within Medical Affairs , the Executive Director will serve as a strategic thought partner and Chief of Staff to the Vice President of Medical ... capabilities aligned with Otsuka's vision, direction, and growth strategy. The Executive Director , Medical Affairs Strategy, Excellence & Operations will lead… more
- Chiesi (Cary, NC)
- …credibility and presence based on their knowledge of all aspects of Medical Affairs . Experience in both clinical development and patient care is preferred. ... The primary responsibility of this role is to lead the PAH/PH-ILD US Medical Affairs team, ensuring alignment with Global Medical Affairs to execute the medical… more
- Veterans Affairs, Veterans Health Administration (Kernersville, NC)
- …OF ASSIGNED DUTIES: In addition to compliance with national and local regulatory policy, and accreditation requirements governing this health care system, this ... they are empowered to meet expected proficiencies in administration, clinical practice, education, and research. Administrative Duties: a. Obligations/Responsibilities:… more
- IQVIA (Durham, NC)
- …for the Data Management, Biostatistics, Programming, Medical Writing, Lifecycle Safety, and Regulatory Affairs functions - and will be responsible for achieving ... ** Director , Data Sciences, Safety and Regulatory ,...Management, Biostatistics, Statistical Programming, Medical Writing, Lifecycle Safety or Regulatory Affairs field is beneficial. + 30%… more
- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- …development programs. + Build professional network with key stakeholders outside of Global Regulatory Affairs to identify regulatory intelligence needs and ... The Associate Director of Regulatory Intelligence leads the...technical discipline preferred. + Minimum of 5 years of regulatory affairs experience. + Minimum 2-3 years'… more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …Ph.D., Pharm. D.,M.D. or equivalent and, 8 years direct experience in Medical Research, Clinical , Regulatory Affairs or other critical areas within the ... product development and/or lifecycle management. Identifies business implications of complex regulatory and clinical issues, develops risk mitigation strategies… more
- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- …INDs, IBs, clinical study reports, and NDAs/BLAs. + Collaborate with regulatory affairs on interactions with global health authorities. + Provides strategic ... emphasis on the large global clinical trials and regulatory filing activities. The Senior Director , GCD is responsible for all the clinical development… more