- GRAIL (Austin, TX)
- …products with the FDA and/or global health authorities. + Support the US Regulatory Affairs team in preparing submissions such as PMAs, 510(k)s, post-approval ... and leadership. They may manage and provide direction to regulatory staff and, when required, participate in senior...of Standard Operating Procedures and policy guidelines within the regulatory affairs department. + Perform other duties… more
- Parexel (Austin, TX)
- …FDA regulatory requirements and processes to a major, dedicated client partnership. As a Senior Regulatory Affairs Associate , you will serve as the ... and guidelines to Parexel! We are currently seeking a highly motivated Regulatory Affairs professional to join Parexel and contribute their knowledge of… more
- Sumitomo Pharma (Austin, TX)
- …seeking a dynamic, highly motivated, and experienced individual for the position of ** Associate Director, Regulatory Affairs (Oncology).** The Associate ... Director is part of the Global Regulatory Affairs (GRA) team based in the US. He/She will...Comfortable presenting to all levels of the organization including Senior Management. **Education and Experience** + Bachelor's degree in… more
- Humana (Austin, TX)
- …as to officials and staff in regulatory and other agencies. The Associate VP, State Affairs requires an in-depth understanding of how organization ... caring community and help us put health first** The Associate VP, State Affairs represents the organization's...Affairs represents the organization's position on legislation and/or regulatory affairs to elected representatives and their… more
- Danaher Corporation (Austin, TX)
- …Learn about the Danaher Business System which makes everything possible.The Senior Director, Medical & Scientific Affairs - Neurodegenerative Disease ... research, product quality, compliance, commercial/marketing activities and customer interactions. This senior role assists the Chief Medical Officer as the medical… more
- Otsuka America Pharmaceutical Inc. (Austin, TX)
- …development programs. + Build professional network with key stakeholders outside of Global Regulatory Affairs to identify regulatory intelligence needs and ... The Associate Director of Regulatory Intelligence leads...technical discipline preferred. + Minimum of 5 years of regulatory affairs experience. + Minimum 2-3 years'… more
- Otsuka America Pharmaceutical Inc. (Austin, TX)
- …accurate, evidence-based, and compliant with internal policies and external regulatory requirements. + Collaborate cross-functionally with Medical Affairs , ... The Associate Director, Scientific Communications manages the execution of...consistency, and compliance. This position reports directly to the Senior Director, CNS Medical Communications Lead. **Key Responsibilities Include:**… more
- Otsuka America Pharmaceutical Inc. (Austin, TX)
- …statistical sections. + Discusses strategies with Global Clinical Development and Regulatory Affairs regarding study design and complex analysis issues, ... team and key stakeholders across different functional areas such as clinical, regulatory affairs , asset management, safety and clinical operation. + Familiar… more
- Danaher Corporation (Austin, TX)
- …and diagnostic confidence for customers worldwide. Position Summary and Impact The Senior Counsel enables LBS' global business strategy by serving as the lead ... multinational environment, with a focus on driving business transformation and innovation. The Senior Counsel will be the lead day-to-day attorney for the leaders of… more
- Otsuka America Pharmaceutical Inc. (Austin, TX)
- …a technical leader within a matrixed organization. + Collaborate with Supply Chain, Regulatory Affairs , IT, and other functions to ensure integrated quality ... **Job Summary** The Associate Director, Quality Operations will lead initiatives that...on key risk indicators and escalate critical risks to senior leadership. **Global Quality System Processes** + Oversee the… more
- Otsuka America Pharmaceutical Inc. (Austin, TX)
- …compounds to drive alignment of labeling content and strategy. + Partner with Global Regulatory Affairs to ensure that all labeling is aligned with the product ... all global labeling components. + Represent Global Labeling on product-specific Regulatory and Cross-Functional teams, as appropriate. + Collaborate with global… more
- Newell Brands (Austin, TX)
- …a related field. + 3-5 years of experience in tax incentives, government programs, regulatory affairs , or a related area (internships or co-op experience may be ... and collaborative environment where you can be your best, every day. The Associate Manager, Tax Incentives & Grants will support the Manager in identifying,… more
- Abbott (Austin, TX)
- …Clinical Data Science and Analytics, Marketing, Regulatory , Legal, Clinical Affairs , Research and senior management to develop and communicate ... more than 500,000 people with diabetes from routine fingersticks. The ** Associate Manager of Clinical Trial Reimbursement** is responsible for implementing and… more
