- 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
- 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
- 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
- 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
- Parexel (Austin, TX)
- …study reports, Investigators Brochures, and other related documents + Contribute to regulatory agency submissions (Investigational new drug applications, new ... while tackling complex safety evaluations that directly impact patient wellbeing and regulatory compliance. **About the Role** As a **Senior Physician in Patient… more
- Christus Health (Euless, TX)
- …audits of pharmacy operations, including compliance with system initiatives, regulatory compliance, associate engagement and talent management. Coordinates with ... standards (Optix). Coordinate and lead system strategies to manage industry drug shortages, including development of system policies, guidance documents, and tools.… more
- Parexel (Austin, TX)
- …describe advanced statistical techniques and interpret results + Familiarity with regulatory /research guidelines on drug development, GCP, and statistical ... works independently on all level complexity clinical trial projects, often with major regulatory impact. The person will be recognized internally and externally as a… more
- Legend Biotech USA, Inc. (Houston, TX)
- …in a timely manner, submitting expenses, etc.Reports adverse events to Legend's Drug Safety department and other internal departments as appropriate per required ... accordance with Corporate, PhRMA, and OIG guidelines.Strict compliance with all regulatory agencies, state, and federal law is required.Adheres to company policies,… more
- Christus Health (East Mountain, TX)
- …department to include daily fulfillment operations, clinical operations, regulatory compliance, business literacy, and committee involvement. Responsibilities: Meets ... The Pharmacy Manager will manage pharmacy distributive services, facilitate drug utilization initiatives, integrate clinical pharmacy programs, oversee pharmacy… more
- Christus Health (Hallsville, TX)
- …department to include daily fulfillment operations, clinical operations, regulatory compliance, business literacy and committee involvement. Responsibilities: Meets ... The Pharmacy Manager will manage pharmacy distributive services, facilitate drug utilization initiatives, integrate clinical pharmacy programs, oversee pharmacy… more
