- ThermoFisher Scientific (Austin, TX)
- …meetings with internal collaborators and external partners. + Collaborate with global regulatory professionals, providing guidance on strategies, submissions, ... meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission...located in Austin, Texas, and is part of the Regulatory Affairs group. This position functions within an office… more
- Parexel (Austin, TX)
- …management experience is required. * Comprehensive understanding of regional and global regulatory requirements, guidelines, and processes. * Proven expertise ... Bring your expert knowledge of FDA regulatory requirements and guidelines to Parexel! We are...for change control and post-approval requirements. * Collaborate with global functions to obtain documentation aligned with local requirements.… more
- Cardinal Health (Austin, TX)
- … experts who provide consulting services in a myriad of capacities, including: + Global Regulatory Strategy Development + Global Regulatory Affairs ... **Position Summary** For nearly five decades, Cardinal Health Regulatory Sciences' industry-trained regulatory consultants have provided expertise and guidance… more
- Otsuka America Pharmaceutical Inc. (Austin, TX)
- …and clinical trial implementation and management. + Complete understanding of the global regulatory requirements. + Working knowledge of marketing and ... data management, and medical writing. + Complete understanding of the global regulatory requirements. Demonstrated experience in successful regulatory… more
- Otsuka America Pharmaceutical Inc. (Austin, TX)
- …the product lifecycle meet Good Manufacturing Practices (GMP) and comply with global regulatory requirements, including DEA regulations. This role partners ... if applicable), ICH Q7 + Strong understanding of GMP requirements and global regulatory expectations for controlled substances. + Experience managing quality… more
- Otsuka America Pharmaceutical Inc. (Austin, TX)
- …assigned compounds to drive alignment of labeling content and strategy. + Partner with Global Regulatory Affairs to ensure that all labeling is aligned with the ... activities related to all global labeling components. + Represent Global Labeling on product-specific Regulatory and Cross-Functional teams, as appropriate.… more
- Otsuka America Pharmaceutical Inc. (Austin, TX)
- …compliance and operational efficiency. + GMP Compliance: Ensure all quality processes meet global regulatory requirements (eg, FDA, EMA, PMDA) and align with ... a global leadership role. + Deep understanding of GMP regulations and global regulatory requirements (eg, 21 CFR Parts 210, 211, 820). + Proven experience in… more
- Otsuka America Pharmaceutical Inc. (Austin, TX)
- …governance practices. **Compliance & Governance** + Ensure quality operations comply with global regulatory requirements (eg, FDA, EMA, PMDA) and internal ... that drive operational excellence, enhance risk management practices, and optimize global quality system processes across a global quality organization.… more
- Otsuka America Pharmaceutical Inc. (Austin, TX)
- …or CRO industry. + In-depth knowledge of ICH-GCP, FDA, EMA, and other global regulatory requirements related to clinical research. + Experience auditing CROs, ... Planning** : Support the development and maintenance of a global audit schedule based on risk assessments, regulatory... global audit schedule based on risk assessments, regulatory requirements, and business priorities. + **Audit Reporting &… more
- Otsuka America Pharmaceutical Inc. (Austin, TX)
- …bodies, payers, academic institutions, and industry consortia. + Ensure compliance with global regulatory and ethical standards in evidence generation and data ... presentations, involvement in scientific/professional associations etc. + Deep understanding of global HTA and payer requirements, regulatory frameworks, and… more