- Parexel (Austin, TX)
- …and/or drug -device combination products are a plus) * Support regulatory leads in developing contingency plans for CMC-related scenarios * Represent CMC ... FDA, EMA, and Health Canada (IND, NDA, DMF) * In-depth understanding of drug development, manufacturing processes, GMP, and regulatory frameworks for small… more
- Otsuka America Pharmaceutical Inc. (Austin, TX)
- **Job Summary** The Chemistry, Manufacturing and Controls (CMC) Global Regulatory Affairs (GRA) professional is responsible for developing and executing global ... regulatory strategies for CMC aspects of small molecule products...post-approval lifecycle activities (supplements, renewals, variations) around small molecule drug substance, drug products and drug… more
- Veterans Affairs, Veterans Health Administration (San Antonio, TX)
- …The Joint Commission (TJC), National Fire Protection Association (NFPA), Food & Drug Administration (FDA), Nuclear Regulatory Commission (NRC), Association for ... the computerized maintenance management system (CMMS) in accordance with regulatory body requirements, Healthcare Technology Management (HTM) Documentation of… more
- Lilly (Houston, TX)
- …This position is responsible for providing GMP/GxP support across the different regulatory reporting and inspection support that is provided by the RCPMR ( ... Regulatory Compliance and Post Market Reporting) team. This includes...shortages, coordinate product shortage notification for OUS countries, update drug and device establishment registrations for changes as the… more
- Parexel (Austin, TX)
- …expertise into strategic impact? We're seeking a sharp, detail-driven **Senior/Consultant, Regulatory Labeling** to join a dedicated partnership with a leading ... consultant - you'll be a trusted collaborator whose insights help shape regulatory strategy and ensure patients worldwide receive safe, effective therapies with… more
- Otsuka America Pharmaceutical Inc. (Austin, TX)
- The Associate Director of Regulatory Intelligence leads the collection and dissemination of regulatory intelligence and collaborates with SMEs to interpret the ... impact of regulatory changes to the pharmaceutical environment. **Job Description** +...JPMA, etc.). + Demonstrate solid working knowledge of the drug , biologic, and device development process, laws, regulations, and… more
- Parexel (Austin, TX)
- …looking to draw upon their wealth of experience in clinical trial design and drug development to join Parexel's highly recognized Regulatory Strategy team! A ... At **Parexel** , we don't just support drug development-we help shape it. As a **Senior/Vice...shape it. As a **Senior/Vice President, Technical** on our Regulatory Strategy (RS) team, you'll be at the forefront… more
- GRAIL (Austin, TX)
- …For more information, please visit grail.com . The role assists with regulatory strategy and the development of submissions in partnership with key internal ... including Multi-Cancer Early Detection (MCED). The position supports the US Regulatory team in preparing Investigational Device Exemptions (IDEs), IDE supplements,… more
- City of College Station (College Station, TX)
- Regulatory Compliance Coordinator Print (https://www.governmentjobs.com/careers/cstx/jobs/newprint/5154679) Apply Regulatory Compliance Coordinator Salary ... Benefits + Questions Description Under the general supervision of the Regulatory Compliance Superintendent, the Regulatory Compliance Coordinator is responsible… more
- Houston Methodist (Houston, TX)
- At Houston Methodist, the Regulatory Compliance Specialist position is responsible for coordinating and performing study specific regulatory processes such as ... by Houston Methodist Research Institute Institutional Review Board (IRB), Food and Drug Administration (FDA) Code of Federal Regulations (CFR), and the International… more