- ThermoFisher Scientific (Austin, TX)
- …Good Manufacturing Practices (GMP) Safety Standards, Office **Job Description** The Sr. Manager, Regulatory Affairs - Drug Support Strategy is a new role ... collaborate with and lead all aspects of professionals in regulatory affairs to develop detailed drug support...professionals in regulatory affairs to develop detailed drug support strategies, ensuring the safe and compliant handling… more
- Otsuka America Pharmaceutical Inc. (Austin, TX)
- … strategy, planning and execution of global investigational and marketed prescription drug submissions and manages lifecycle regulatory activities in alignment ... **Position Summary** Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed prescription … more
- 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
- 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
- Otsuka America Pharmaceutical Inc. (Austin, TX)
- …experience strongly preferred. - Advanced analytic skills, and general understanding of the drug development and regulatory process. - Successful track record of ... business days. **Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death &… 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