- 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
- Charles Schwab (Westlake, TX)
- …and FR2052a reports to ensure accuracy and completeness. + Perform daily on-time regulatory submissions of the FR 2052a reports. + Maintaining internal ... corporation and its subsidiaries, including our bank and broker-dealers. We monitor regulatory ratios and adherence, and develop associated tools to assist our… 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)
- …solutions to facilitate their research goals. In collaboration with Sr. Pre-Clinical Regulatory Analysts, the IACUC Manager , and the ORP leadership, this ... regulatory committee reviews. Prepares succinct synopsis for all protocol submissions , highlighting any regulatory considerations or determinations the… 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