- Boehringer Ingelheim (Ridgefield, CT)
- …and Scientific Communications, clinical operations, translational medicine and clinical pharmacology, and regulatory affairs. This position will require ... **Description** The Clinical Development and Medical Affairs Fellow is a...regulatory activities required of an NDA Holder for compliance to FDA requirements for US products in BIPI's… more
- GRAIL (Menlo Park, CA)
- …products, including labeling, promotional materials, product changes, and documentation required for compliance and regulatory approval. + Monitor and report on ... + Support internal and external quality audits. + Ensure compliance with all regulations and laws applicable to GRAIL's...**Experience** + Minimum of 10 years of experience in regulatory , development, clinical affairs, quality, or program… more
- Abbott (Santa Clara, CA)
- … requirements to software systems, including documentation, risk management, and compliance strategies. Assists management and leadership on regulatory ... other members of regulatory and related teams. + Evaluate risk of and regulatory solutions to product and clinical safety issues during clinical phases… more
- Mohawk Valley Health System (Utica, NY)
- …initiatives and support of patient advocate processes. + Oversee enterprise-wide compliance with ongoing regulatory and accreditation readiness sustaining ... of the response needed. + Collaborates with many other departments to ensure compliance with regulatory information. + Ongoing relationships with DOH, DNV,… more
- Globus Medical, Inc. (Audubon, PA)
- …of exceptional response by partnering with researchers and educators to transform clinical insights into tangible solutions. Our solutions improve the techniques and ... their lives as quickly as possible. **Position Summary** **:** The Manager, Regulatory Affairs, is responsible for preparing, filing and gaining approval of 510(k),… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- …following:** + Coordinate the preparation, submission, management and maintenance of global regulatory submissions related to clinical and nonclinical aspects of ... product development activities/meetings + Perform research to support the development of regulatory strategy for the assigned clinical development program +… more
- ThermoFisher Scientific (Austin, TX)
- …Regulatory Affairs department. This is a fantastic opportunity to further develop your regulatory career and expertise in a global clinical trial setting. You ... regulatory strategies on assigned (Phase 1 to 4) clinical trials, studies and projects and providing the technical/...training and guidance to junior team members. + Ensure compliance with relevant organizational and regulatory SOPs… more
- Lilly (Indianapolis, IN)
- …byleveragingteam expertise, as well as scientific, drug/device clinical development and knowledgefromhealth authorities such as ... countries + Industry-relatedexperiencein regulatoryaffairsand/ordrugdevelopmentexperiencefor 10years + Direct experience in clinical and CMC regulatory sciences + Experience… more
- BeOne Medicines (San Mateo, CA)
- …primarily in the United States with some activities globally to ensure compliance with applicable regulatory requirements and guidelines, and consistency with ... teams, medical affairs, and marketing. + Provide advice on healthcare regulatory matters across business functions, including commercial, clinical development,… more
- Emory Healthcare/Emory University (Atlanta, GA)
- …responsible for coordinating and managing the operational activities that support regulatory compliance , accreditation readiness, policy oversight, and quality ... and Performance Monitoring:** 1. Manage the collection, analysis, and reporting of regulatory compliance and quality metrics to inform decision-making and… more