- 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 (Miami, 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
- J&J Family of Companies (Palm Beach Gardens, FL)
- … compliance issues. + Lead all aspects of the preparation and maintenance of regulatory submissions and files. + Establish accountability for the preparation of ... America **Job Description:** We are searching for the best talent for ** Manager , Regulatory Affairs** to support the Power Tools team within our Orthopaedics… more
- Deloitte (Tampa, FL)
- …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
- 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
- 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
- Eliassen Group (Tallahassee, FL)
- …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
- Sumitomo Pharma (Tallahassee, FL)
- …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 (Tampa, 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