- 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...Ideally with a minimum of 4 years focused in regulatory affairs + Oncology product development experience… more
- ThermoFisher Scientific (Wilmington, NC)
- …ensure audit readiness. -Advanced understanding of global/regional/national requirements and regulatory affairs procedures for clinical trial authorization, ... operational leadership for the department, overseeing innovative solutions including regulatory expertise and client interface to provide strategic regulatory… more
- GRAIL (Durham, NC)
- …products with the FDA and/or global health authorities. + Support the US Regulatory Affairs team in preparing submissions such as PMAs, 510(k)s, post-approval ... and review of Standard Operating Procedures and policy guidelines within the regulatory affairs department. + Perform other duties as assigned. **Required… more
- Cardinal Health (Raleigh, NC)
- …joins a team of medical affairs professionals who report to the Sr Director of Regulatory & Medical Affairs . **Responsibilities:** + Collaborate across ... hours. We also provide customers the support they need in regulatory compliance, reimbursement, continuing education, information management and other crucial areas,… 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)
- …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 ... operating plan and Medical Affairs strategy for PAH/PH-ILD within the US, as part...colleagues including provides medical input on US labeling and regulatory interactions + Ensures timely and appropriate management of… more
- Merck (Raleigh, NC)
- **Job Description** The US Director of Medical Affairs (DMA) for Gynecologic Malignancies (Ovarian, Endometrial and Cervical Cancer) holds primary responsibility ... for the development and execution of regional oncology Medical Affairs strategies and plans for Gynecological Malignancies in the...interactions with Patient Advocacy Groups + Tracks guidelines and regulatory landscape in the US region + Review of… more
- Lowe's (Mooresville, NC)
- **Your Impact** The primary purpose of the Director , Government Affairs position is to lead the advocacy on behalf of Lowe's in the company's key strategic and ... markets for the assigned markets - South Divisions and/or Headquarters State. This Director position leads the advocacy before state and local legislative and … more
- UNC Health Care (Goldsboro, NC)
- **Description** Summary: The Vice President, Medical Affairs and Chief Medical Officer is responsible for medical affairs of the hospital and for providing ... with daily operations, quality patient care, and compliance with legal, regulatory , accreditation and The Joint Commission standards and requirements. Collaborates… 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