- Sumitomo Pharma (Tallahassee, FL)
- …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. (Tallahassee, FL)
- …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 Myers, FL)
- …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 (Tampa, FL)
- …available Preferred: + Understanding of pharmaceutical regulatory data and regulatory filing requirements and generating submissions packages + Experience ... role ends on 8/31/2025 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
- Citigroup (Tampa, FL)
- The Liquidity Management Group Manager is a leadership position within the Treasury Organization. The individual is responsible for leading the team within Liquidity ... team partners with Liquidity Management for funding management and Regulatory Reporting daily. The individual will lead a team...work by junior staff and ensure timely and accurate submissions to various stakeholders + Manage a global production… more
- TD Bank (Fort Lauderdale, FL)
- …ongoing supervision. Teammates interact directly and independently with auditors and regulatory agencies and provides approval for document submissions to ... + 7+ years of experience **Preferred Background & Experience:** + **Certified Regulatory Compliance Manager or similar knowledge of consumer, commercial, and… more
- University of Miami (Miami, FL)
- …contract submissions and liaison with all contract stakeholders + Complete IRB/ Regulatory submissions and liaison with all IRB stakeholders + Ensure Informed ... Psychiatry has an exciting opportunity for a full-time Project Manager , Research Support to work on the UHealth campus....List of duties: + Complete quarterly and annual report submissions + Assist with all aspects of proposal … more
- Sumitomo Pharma (Tallahassee, FL)
- …medical writing-to maintain the statistical integrity of study conduct. + Support regulatory submissions by preparing responses to agency inquiries and ... Safety (ISS) and Integrated Summary of Efficacy (ISE) strategy for NDA/BLA submissions , ensuring compliance with regulatory expectations. + Collaborate closely… more
- Deloitte (Miami, FL)
- …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
- University of Miami (Miami, FL)
- …the efforts of relevant team members to manage, retain and control all applicable Regulatory Affairs submissions pertaining to University held INDs and IDEs as ... . The Clinical Translational Research Site is currently seeking a full time Manager , Clinical Research to work in Miami. The Manager , Clinical Research… more