- Amneal Pharmaceuticals (Piscataway, NJ)
- …Global Regulatory Strategies: Formulate and lead global CMC and clinical regulatory strategies for Biologics, Biosimilars, and Small Molecules.Ensure ... alignment with regulatory trends, innovation, and compliance while balancing business benefits and risks. + Lead and Manage Global Submission Activities: Oversee… more
- Johns Hopkins University (Baltimore, MD)
- …Dean of Clinical Affairs (VDCA)/President of the CPA (dual role), the Associate Dean of Clinical Affairs (ADCA), and the Executive Director, Faculty ... We are seeking a **_Sr. Director, Office of Vice Dean of Clinical Affairs & Faculty Practice Plan_** for the Office of Vice Dean of Clinical Affairs … more
- University of Colorado (Aurora, CO)
- ** Associate Dean for Faculty Affairs Open...and the Dean's Office, including with the Office of Clinical Affairs , Office of Research, Office of ... the Dean, Office for the Faculty Experience** **Job Title: Associate Dean for Faculty Affairs ** **Open Rank-...with the Office of Legal Counsel, human resources, and regulatory bodies to develop, revise, and implement faculty policies… more
- AbbVie (Mettawa, IL)
- …interpretation, and reporting of scientific content of protocols, Investigator Brochures, Clinical Study Reports and regulatory submissions and responses. + ... Has overall responsibility for oversight of the Medical Affairs -led clinical studies, monitoring overall study integrity and review, interpretation and… more
- Amgen (Washington, DC)
- …alongside other innovative, driven professionals in this meaningful role. **Companion Diagnostic Regulatory Affairs Manager** **Live** **What you will do** Let's ... or Regulatory experience **Preferred Qualifications:** + MS Degree + Degree in Regulatory Affairs , Life Sciences, or Engineering + 6 plus years of experience… more
- Novo Nordisk (Plainsboro, NJ)
- … agencies. Supervise designated personnel. Relationships Report to the Director Regulatory Affairs . Develop and maintain positive rapport and working ... About the Department The Clinical , Medical and Regulatory (CMR) department...relationships with other personnel in Regulatory Affairs , CMR, and other local and… more
- Dr. Reddy's Laboratories (Princeton, NJ)
- …exploring candidates with a less traditional background. **Job Description** We are seeking an Associate for our North America Medical Affairs team. This is a ... Serve as medial lead for meetings or responses to regulatory agencies * Work closely with Head, Pharmacovigilance and...agencies * Work closely with Head, Pharmacovigilance and Medical Affairs to ensure standards of medical & clinical… more
- UNC Health Care (Rocky Mount, NC)
- …impact on our community's health and wellbeing. Summary: The Coordinator of Accreditation, Regulatory Affairs & Quality Support Services will provide a wide ... state and federal surveys. . Oversee all accreditation and regulatory survey activity and direct the responses to these...or other health related field with 5 years of clinical experience, associate degree in nursing 10… more
- Lilly (Indianapolis, IN)
- …make life better for people around the world. **Purpose:** The Senior Director of Global Regulatory Affairs - CMC (GRA-CMC) leads and manages the scientific and ... Ensures department has broad technical knowledge and expertise in global CMC regulatory requirements and guidelines for conducting clinical trials, obtaining… more
- Takeda Pharmaceuticals (Boston, MA)
- …in coordination with relevant cross-functional teams (including members of medical affairs , clinical development, and outcomes research; global, regional, or ... and be empowered to deliver your best. As part of the Global Medical Affairs Oncology team, you will report to the Scientific Communications Group Lead, Hematology.… more