- Unknown (Dallas, TX)
- …international submissions. The role also involves supporting all aspects of global commercial product regulatory affairs. The VP will be accountable for ... Vice President, Regulatory Affairs, Oncology About the Company Globally-recognized pharmaceutical...teams, and ensuring the compliance of promotional materials with FDA regulations and company policies. Applicants for the Vice… more
- Unknown (Dallas, TX)
- …Specialties life sciences diagnostics dental water quality and product identification and biotechnology Business Classifications E-Commerce B2B Enterprise ... structuring, writing, and negotiating agreements, as well as advising on regulatory , compliance, privacy, and litigation matters. Applicants must have a Juris… more
- ThermoFisher Scientific (Austin, TX)
- …is safe or helping find cures for cancer. **Discover Impactful Work** As a Sr. Manager , Regulatory Affairs, you will play a crucial role in interpreting and ... and communicate the impact of relevant global regulations, guidelines, and evolving regulatory trends relating to pharmaceutical product development in the area… more
- Otsuka America Pharmaceutical Inc. (Austin, TX)
- …drug products and drug-device combination products. Ensure compliance with global regulations ( FDA , EMA, ICH, WHO) and anticipate regulatory changes impacting ... strategies for post-approval changes, line extensions, and global harmonization of product registrations. Monitor and implement regulatory updates impacting… more
- Oracle (Austin, TX)
- **Job Description** This role is dedicated to understanding healthcare regulatory requirements (such as HIPAA, HITRUST, FDA , etc.) and guiding cross-functional ... functions. Excellent communication, documentation, and executive presentation skills. Familiarity with regulatory frameworks (eg, HIPAA, HITRUST, FDA ) and their… more
- Oracle (Austin, TX)
- …our next-generation EHR and AI-enabled medical device platforms. As a Clinical Product Manager (Medical Device Focus), you'll provide clinical insight into ... for Clinical Evaluation Reports (CERs), including alignment with EU MDR and FDA regulatory requirements. . Oversee usability engineering (IEC 62366), ensuring… more
- Oracle (Austin, TX)
- …our next-generation EHR and AI-enabled medical device platforms. As a Clinical Product Manager (Medical Device Focus), you'll provide clinical insight into ... for Clinical Evaluation Reports (CERs), including alignment with EU MDR and FDA regulatory requirements. . Oversee usability engineering (IEC 62366), ensuring… more
- Otsuka America Pharmaceutical Inc. (Austin, TX)
- The Senior Manager , Global Product Quality - Biologics is responsible for managing quality oversight of clinical and commercial products at CMOs under contract ... and transported in a controlled way that is in accordance with regulatory expectations and applicable GMP/GDP quality standards. This role will provide specialized… more
- Abbott (Austin, TX)
- …medicines. Our 114,000 colleagues serve people in more than 160 countries. **Job Title** Product Manager **Working at Abbott** At Abbott, you can do work that ... around the world. + Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company policies, operating procedures,… more
- Fujifilm (College Station, TX)
- …an engineering role in a pharma/biotech manufacturing facility or equivalent, preferably regulated by FDA or any other regulatory agency; OR + Master's degree in ... **Position Overview** The Principal Engineering Manager - Reliability Engineering at Fujifilm Biotechnologies Texas...a pharma/biotech manufacturing facility or equivalent, preferably regulated by FDA or any other regulatory agency +… more
