- Taiho Oncology (Pleasanton, CA)
- …Reports. + Investigator Brochures. + Population PK and/or Exposure-Response reports. + Regulatory Documents, including NDAs and MAAs and responses to questions from ... regulatory authorities. + Academic publications, including scientific meeting abstracts and peer-reviewed articles. + Lead the implementation of operational… more
- University of North Carolina- Chapel Hill (Chapel Hill, NC)
- …position is part of UNC's new NIH / FDA -funded Center for Tobacco Regulatory Science and Health Equity. We are looking for candidates interested in developing ... postdoc will also develop their own research questions regarding tobacco regulatory science and will receive multidisciplinary training and mentorship from senior… more
- Cambrex High Point (Charles City, IA)
- …years of experience in administering controlled substances or products with strict regulatory guidelines. Strong working knowledge of DEA regulatory requirements ... highly beneficial. Cambrex is committed to providing a safe and productive work environment. All offers of employment are contingent on the successful completion of a comprehensive pre-employment screen. The pre-employment screen may consist of several… more
- AbbVie (North Chicago, IL)
- …. Ensure technology systems compliance with Data Security, Data integrity and Regulatory Standards are maintained across automation activities in SM CMC R&D. . ... and biotechnology manufacturing processes, including operational best practices and regulatory expectations. . Knowledge and industry experience exposure to FDA,… more
- Touro University (Hawthorne, NY)
- Overview Responsible for pre-clinical trial set up, initial and ongoing regulatory submission and IRB activities, subject screening and enrollment, specimen ... forms; prepare for routine data audits and maintain source documents and regulatory binders. Manage communications- mail, phone, fax, e-mail for COG, sponsored,… more
- RTX Corporation (Irving, TX)
- …mitigate potential risks in contracts, ensuring compliance with legal and regulatory requirements. Partner with IT Asset Management (ITAM) function to lead/support ... within a high-volume, high-mix portfolio. Stay informed of industry trends, regulatory changes, and best practices in software contracting. + **Project Management:**… more
- Kerry (Melrose Park, IL)
- …safety programs such as; safety orientation, safety committee, ergonomic committee, monthly regulatory safety trainings and Eye for safety program. + Follow all ... Kerry safety, environmental and regulatory policies, procedures, and guidelines. May perform any other duties assigned by leadership. Required to maintain adequate… more
- JPMorgan Chase (New York, NY)
- …from the need to anticipate and respond to significant industry or regulatory developments. The team works closely with senior stakeholders and collaborates across ... implement scalable operating models aligned with strategic business initiatives and regulatory requirements + Ensure timely delivery and smooth transition of… more
- Ascendis Pharma (Princeton, NJ)
- …and updates of training curricula to maintain relevance and compliance with regulatory standards. 2. Training Facilitation and Trainer Certification + Lead live and ... Collaboration + Partner with cross-functional teams including Clinical Development, Regulatory Affairs, and Commercial to align training initiatives with strategic… more
- SUNY Upstate Medical University (Syracuse, NY)
- …for the coordination of ALS clinical research studies. Performance of regulatory tasks including IRB and sponsor/CRO regulatory correspondence. Communication ... with IRBs, sponsors, and protocol-related Upstate Departments. Pre-screen, Screen, and enroll research participants in outpatient ALS clinical trials. Additional duties include but are not limited to: process and ship lab samples, schedule and conduct follow… more