- ThermoFisher Scientific (Austin, TX)
- … strategies! + Responsible for providing guidance to ensure that all regulatory submissions are planned, communicated, and performed per regulatory ... Sequencing and/or PCR assays + Facilitate FDA pre-submission meetings + Prepare US regulatory submissions (PMA, PMA supplement, and 510(k)) for Next Generation… more
- Otsuka America Pharmaceutical Inc. (Austin, TX)
- …pharmaceutical and/or healthcare industry. - Knowledge and experience with preparation of global regulatory submissions (IND, CTA, NDA or BLA, MAA). - RAC ... planning and execution of global investigational and marketed prescription drug submissions and manages lifecycle regulatory activities in alignment with… more
- Grifols Shared Services North America, Inc (Fort Worth, TX)
- …the scope of experimentation and the selection of data needed to support regulatory submissions . + Interacts with regulatory authorities regarding programs ... and development of contingency plans. + Ensures that technical documentation for regulatory submissions meets the appropriate standards and content requirements… 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
- American Electric Power (Austin, TX)
- …of a forward-thinking organization, this is the company for you! AEP seeks a Regulatory Case Manager . This role is responsible, with the operating company, for ... + Lead a comprehensive initiative to prepare, file, and manage significant submissions with state regulatory commissions in collaboration with operating… more
- Deloitte (Houston, TX)
- …available Preferred: + Understanding of pharmaceutical regulatory data and regulatory filing requirements and generating submissions packages + Experience ... this role ends 6/30/2025 Work You'll Do As a Manager you will lead and deliver engagements, or components...4+ years of experience in Life Sciences Pharmaceutical R&D regulatory domain. Experience to include: introducing new technologies like… more
- Fresenius Medical Center (Dallas, TX)
- …operational activities within Regulatory Affairs for the preparation of regulatory submissions required to market new or existing licensed pharmaceuticals ... ways. + Responsible for the preparation, compilation, quality check and delivery of regulatory submissions in both paper and/or electronic format in accordance… more
- Houston Methodist (Houston, TX)
- …as DOA logs, assist with reporting RNIs, reporting deviations, perform IRB submissions , amendments. The Regulatory Compliance Specialist will be responsible for ... sponsor's regulatory team. This position communicates with regulatory affairs office for FDA submissions across...Manager or Director (serves as a resource for regulatory information and guidance). + Conducts self in a… more
- CAE USA INC (Dallas, TX)
- …assistance. + Participate in relevant industry meetings + Coordinate, prepare, or review regulatory submissions as required + Provide Regulatory Training on ... About This Role Support the FSTDO Standards & Compliance Manager in work related to ensuring FSTDO standards and... in work related to ensuring FSTDO standards and regulatory compliance for the assigned region, responsibilities include but… more
- Abbott (Plano, TX)
- …Plans (PMS) and Post-Marketing Clinical Follow-up Plans (PMCF). + Facilitates regulatory submissions and communications by communicating with Regulatory ... of regulatory responses for Notified Body questions upon review of submissions . + Provide strategic guidance on regulatory requirements, pertaining to… more
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