- Sumitomo Pharma (Albany, NY)
- …agencies. + Understands evolving Health Authority (HA) standards and procedures for regulatory submissions . Guides and trains project teams on new requirements, ... of external publishing staff contracted to publish and dispatch health authority submissions . + Represents Regulatory Operations on project teams for matters… more
- Otsuka America Pharmaceutical Inc. (Albany, NY)
- …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 (Manhattan, NY)
- …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
- Meta (New York, NY)
- …device regulatory affairs or related industry 9. Experience in global regulatory submissions and product approvals 10. Experience communicating and leading ... software as a medical device direct to consumer space. You will lead regulatory strategy development, submissions , and approvals for United States and… more
- JPMorgan Chase (New York, NY)
- …for regulatory requests. + Analyze and summarize information for regulatory submissions , ensuring confidentiality and accuracy. + Package regulatory ... we are dedicated to maintaining a strong and resilient organization. As a Regulatory Strategy Senior Officer, you will be instrumental in ensuring our firm grows… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- …+ Lead all aspects of the completeness and accuracy of information provided in regulatory submissions . + Lead and advise the planning, preparation and submission ... teams on the content, format, style architecture and timing of regulatory submissions . + Evaluate applications and conformance with the regulatory … more
- KeyBank (Buffalo, NY)
- …a critical part in ensuring the completeness, accuracy, and timeliness of regulatory submissions by enhancing control frameworks, supporting data governance ... 44114 **Position Summary:** Key is seeking a detail-oriented and proactive Regulatory Reporting Governance Senior Analyst to support the governance, oversight, and… more
- Danaher Corporation (Cortland, NY)
- …for compliance with regulations and statutes. Determine the need for and prepare regulatory submissions , negotiate the resolution of agency questions, and secure ... (https://www.danaher.com/how-we-work/danaher-business-system) which makes everything possible. Director Global Quality and Regulatory Compliance JOB SUMMARY Interprets federal/state/international regulations as they… more
- Citigroup (Getzville, NY)
- …audit reviews, provide supporting documentation to support reported values related to regulatory report submissions + Develop and execute plans, policies and ... The Regulatory Analytics Senior Analyst is an SVP level position, part of the Regulatory and Analytics function within Enterprise Data Office, the SVP will be… more
- Citigroup (Getzville, NY)
- …audit reviews, provide supporting documentation to support reported values related to regulatory report submissions + Develop and execute plans, policies and ... The Regulatory Analytics Analyst is a VP level position, part of the Regulatory and Analytics function within Enterprise Data Office, the VP will be supporting … more