- Sumitomo Pharma (Austin, TX)
- …are currently seeking a dynamic, highly motivated, and experienced individual for the position of ** Senior Manager , Regulatory Affairs ** . The Senior ... Manager is part of the Global Regulatory Affairs (GRA) team based in the US and he/she will primarily function as a regional regulatory leader (RRL) and… more
- Otsuka America Pharmaceutical Inc. (Austin, TX)
- …with 5+ years' experience or Master's degree with 2 years' experience in regulatory affairs or related areas (eg, clinical development, project management, ... **Position Summary** Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed prescription… more
- Otsuka America Pharmaceutical Inc. (Austin, TX)
- Provide CMC regulatory strategy input and expertise in the area of investigational, new and marketed biologic and small molecule drug products to assigned project ... ensure Otsuka's products are developed/maintained in compliance with global regulatory requirements and guidances. Primary regions/markets of responsibility include… more
- Cardinal Health (Austin, TX)
- …plans for product development programs and regulatory submissions. **_Job Summary_** The Manager , Regulatory Affairs directs regulatory affairs ... **_What Regulatory Affairs contributes to Cardinal Health_**...and provides insights to senior leadership regarding regulatory developments. The Manager leads a team… more
- Otsuka America Pharmaceutical Inc. (Austin, TX)
- …Successful engagement in multiple initiatives simultaneously + Certification (such as Regulatory Affairs Professionals Society (RAPS)) + Prior project management ... The Sr. Manager , CTA Regulatory Strategy is responsible for providing critical support in developing global regulatory strategy, planning, and execution of… more
- Houston Methodist (Houston, TX)
- …and the International Conference on Harmonization (ICH). This position communicates with regulatory affairs office for FDA submissions across multiple studies of ... At Houston Methodist, the Senior (Sr.) Regulatory Compliance Specialist position...experience **LICENSES AND CERTIFICATIONS - REQUIRED** + RAC - Regulatory Affairs Certifications (RAPS) **OR** + CCRC… more
- Abbott (Plano, TX)
- …operations, product performance, medical affairs , Clinical R&D, Quality Engineering, regulatory affairs , product labeling, senior management, and ... and exchange of documents between stakeholders (eg, internal personnel such as Regulatory Affairs , R&D Engineering, Clinical Engineering, A&P and Marketing,… more
- Edwards Lifesciences (Dallas, TX)
- …difference to patients around the world. From design to production, our Regulatory Affairs teams help guide our innovative technologies through complex ... international regulatory environments....scientific content repository + Other incidental duties: Represent Medical Affairs in various internal and external programs **What you'll… more
- Otsuka America Pharmaceutical Inc. (Austin, TX)
- **Job Summary** Senior Manager , GPV Aggregate Report & RMP Operations Apply knowledge and expertise in the area of aggregate reports and risk management plans. ... as outside of GPV + Interface with other functional groups, such as Regulatory Affairs , Clinical Management/Clinical Development or other business units as… more
- Applied Materials (Austin, TX)
- …closely with cross-functional teams, including product development, engineering, legal, and regulatory affairs , to ensure compliance requirements are integrated ... continue to expand our operations, we are seeking a highly skilled and experienced Senior PMO to support our Product Regulatory Compliance program. This critical… more