- Aldevron (Fargo, ND)
- …and procedures and collaborating with cross-functional teams, including Clients, Regulatory Affairs, and Marketing, to develop labeling strategies that align ... with regulatory requirements and company branding.This is a remote position...of the job include:5+ years of relevant experience in drug product label/labeling required,Experience with labeling equipment qualification and… more
- Cepheid (Miami, FL)
- …state, and federal regulations and standards including compliance with Food & Drug Administration (FDA), ISO 13485, European Union In Vitro Diagnostic Regulation ... (IVDR) as well as other applicable global regulatory requirements, including Medical Device Single Audit Program (MDSAP) participating regulatory authorities… more
- Cardinal Health (Phoenix, AZ)
- …Biotech and Medical Device/Medical Diagnostics with success + Experience selling consulting, drug development, regulatory services preferred + Highly organized + ... **Position Summary** For nearly five decades, Cardinal Health Regulatory Sciences' industry-trained regulatory consultants have provided expertise and guidance… more
- IQVIA (Durham, NC)
- …Management (Associate) Director will play a critical role in supporting the Regulatory Affairs and Drug Development Solutions (RADDS) team-not through direct ... alignment to help drive success. This is role focuses on the Drug Development & Regulatory Strategy (DDRS) offerings within RADDS. The individual will be focused… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …+ Extensive experience developing companion diagnostics and devices. + Experience of drug development and drug regulatory procedures. + Understanding ... of strategic and tactical role and deliverables of Global Regulatory Strategy in the Drug and Device Development and Commercialization process. + Experience with… more
- Teva Pharmaceuticals (West Chester, PA)
- …5% international travel required. **Your experience and qualifications** Bachelor's degree in Drug Regulatory Affairs, Pharmacy, Biology, Chemistry, or a related ... or Batch Records + Regulatory Reporting Requirements, Regulatory Assessments and Impact on Implementation + Drug... Regulatory Assessments and Impact on Implementation + Drug , Biologic, or Biosimilar Development + SOP Training and… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- … Affairs, Precision Medicine, you will help develop and execute Precision Medicine regulatory strategy in alignment with the drug global regulatory ... as applicable. You will provide fit-for-purpose operational and technical diagnostics (Dx) regulatory assistance through all stages of drug clinical programs,… more
- UPMC (Pittsburgh, PA)
- …Drug Administration (FDA) is essential. **OR** 1+ years' experience in drug development, regulatory or clinical operations functions is preferred, Exceptional ... cancer. UPMC Hillman Cancer Center is currently hiring a regular full-time ** Regulatory Specialist** to help support the Oncology Clinical Research Services team… more
- Gilead Sciences, Inc. (Foster City, CA)
- …BA/BS with 10+ years' relevant experience. + 4+ years' experience in prescription drug labeling. + Significant regulatory experience in the biopharma industry is ... their aspirations. Join Gilead and help create possible, together. **Job Description** Regulatory Affairs Labeling is a core function within Gilead's Global … more
- Lilly (Indianapolis, IN)
- …effecting change in regulatory policies that advance patient outcomes, reduce regulatory risk, and improve efficiency in drug development. The purpose of ... vision, which will center around topics that encourage innovation in drug development and regulatory review of medicines targeting various types of cancers. +… more
- Lilly (Indianapolis, IN)
- …effecting change in regulatory policies that advance patient outcomes, reduce regulatory risk, and improve efficiency in drug development. The purpose of ... which will center around topics that encourage innovation in drug development and regulatory review of genetic and neuroscience medicines + Critically review… more
- Takeda Pharmaceuticals (Lexington, MA)
- …Utlizes profound GRA CMC knowledge underpinned by a deep understanding of global drug development and regulatory essentials to address and overcome challenges ... Highly proficient understanding of scientific principles and profound grasp of global regulatory CMC requirements relevant to global drug development and… more
- J&J Family of Companies (Raritan, NJ)
- …of the drug development process + Basic understanding of the regulatory submission and approval process + Knowledge of US guidelines and practices in ... setting for improved efficiencies. **Preferred:** + Direct experience in regulatory affairs is desirable + Oncology Drug ...in regulatory affairs is desirable + Oncology Drug Development experience + Regulatory , Clinical or… more
- Takeda Pharmaceuticals (Boston, MA)
- …teams and mentoring colleagues. + Significant experience in global drug development regulations, regulatory submissions, lifecycle management, compliance, ... the USA or more jurisdictions. + Understanding of scientific principles and regulatory standards/requirements relevant to global drug development and post-market… more
- University of Colorado (Aurora, CO)
- …**Condition of Employment:** **Preferred Qualifications:** + Experience with investigational drug services, clinical research operations, or IRB/ regulatory ... of pharmacy practice** with a particular interest in clinical research, investigational drug management, and regulatory compliance in academic or healthcare… more
- Sanofi Group (Cambridge, MA)
- …also be key deliverables. **Knowledge:** + Proven experience in global medical devices regulatory for drug -led combination products and standalone drug ... in either a project or functional context + Poven experience in drug /device combination product regulatory approvals + Demonstrate strategic thinking,… more
- United Therapeutics (Research Triangle Park, NC)
- …of preclinical studies to ensure the successful submission and approval of a drug product by regulatory agencies. This role will provide scientific insight ... an option. **Who you are** We are seeking a highly motivated Clinical Drug Development Scientist to join our team. You will support the design, implementation,… more
- University of Maryland, Baltimore (Baltimore, MD)
- …regulatory agency site visits. This program covers all major areas of drug product and biologics regulatory science, including: Chemistry, Manufacturing, and ... fulfill the faculty position of Instructor (non-tenure track) for the MS in Regulatory Science within the Department of Pharmaceutical Sciences. The MS in … more
- Takeda Pharmaceuticals (Boston, MA)
- …ensure the integrity, compliance, and oversight of data related to the drug development lifecycle, including regulatory submissions, labeling, and product ... of regulatory updates on data, coordinating with regulatory teams (eg, submission publishing, CMC, drug ...with regulatory teams (eg, submission publishing, CMC, drug labeling, compliance, and IT) to achieve aligned and… more
- Takeda Pharmaceuticals (Boston, MA)
- …major initiatives. **Minimum** **Requirements/Qualifications:** + Applies comprehensive knowledge of drug development and CMC regulatory requirements in ... in order to bring life-changing therapies to patients worldwide. The Director CMC Regulatory Affairs is responsible for ensuring regulatory approval for new… more
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