- Sumitomo Pharma (Austin, TX)
- …agencies. + Understands evolving Health Authority (HA) standards and procedures for regulatory submissions . Guides and trains project teams on new requirements, ... a dynamic, highly motivated, and experienced individual for the position of Senior Manager , Regulatory Operations, For assigned projects, the Senior Manager … 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
- Deloitte (Houston, TX)
- …available Preferred: + Understanding of pharmaceutical regulatory data and regulatory filing requirements and generating submissions packages + Experience ... role ends on 7/31/2025 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
- 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
- Eliassen Group (Austin, TX)
- …the lights on" with respect to legacy systems that are being used for submissions to meet regulatory requirements across the globe. Regulatory requirements ... transparency and informed decision-making. **Experience Requirements:** + Experience with regulatory environments and submissions requirements for compliance in… more
- Robert Half Finance & Accounting (Fort Worth, TX)
- Description We're looking for an individual to fill the role of SEC Reporting Manager in Fort Worth, Texas for our client in the transportation sector. This is one ... and a beautiful campus. This pivotal role centers on managing the regulatory filing process and ensuring precise financial reporting that underpins transportation… more
- Sumitomo Pharma (Austin, TX)
- …in risk mitigation strategies preferred. + Experience preparing safety reports and submissions to FDA, EMA, and/or other regulatory authorities. + Effective ... LinkedIn (https://c212.net/c/link/?t=0&l=en&o=4190475-1&h=2504638834&u=https%3A%2F%2Fwww.linkedin.com%2Fcompany%2Fsumitomo-pharma-america%2F&a=LinkedIn) . **Job Overview** The Senior Manager , Pharmacovigilance Scientist serves as the primary… more
- Deloitte (Houston, TX)
- …Q8, Q9, Q10), FDA/EMA/PMDA regulations, and the structure/content of CMC sections in regulatory submissions (IND, NDA, BLA, MAA) + 1+ years experience leading, ... equitable future of health. Work You'll Do As a Manager you will lead and deliver engagements, or components...like GenAI, AI/ML, and automation for analytical methods, manufacturing, regulatory and/or QA/QC + Implementation of regulatory … more
- NCR VOYIX (Irving, TX)
- …the world to your local favorite around the corner. Title: Senior Manager , Payments Compliance Location: Irving, TX (onsite) SUMMARY: Develop, enhance, and manage ... teams to effectively mitigate compliance risk + Manage relationships with regulatory associations and sponsor banks + Ensure coordination and compliance with… more
Recent Jobs
-
Senior Principal Scientist, Translational Development, Pancreatic Cancer Disease Lead
- Bristol Myers Squibb (Cambridge, MA)
-
Patient Registrar Full-time Dayshift
- HCA Healthcare (St. Petersburg, FL)
-
Senior Director, Office of Equal Opportunity
- NYU Rory Meyers College of Nursing (New York, NY)
-
Senior Information Technology Specialist, ISD (Cyber Security)
- The County of Los Angeles (Los Angeles, CA)