- Huntington National Bank (Pittsburgh, PA)
- …teams, provide constructive feedback and recommendations intended to enhance quality of regulatory submissions . + Performs other duties as assigned. Basic ... all facets of planning, execution, delivery, and maintenance of these regulatory -driven programs. These activities will include creating or sourcing information from… more
- Sumitomo Pharma (Harrisburg, PA)
- …support company objectives. + Champion regulatory and technical documents for regulatory submissions in support of manufacturing and serve as subject matter ... Collaborate with the process and analytical development, quality, and regulatory functions to establish a robust, compliant clinical supply...expert in regulatory interactions. + Maintain a high level of safety,… more
- Geisinger (Danville, PA)
- …for assisting with coordination of research projects including protocol implementation, regulatory submissions , project planning, project tracking, and data ... with the project manager. + Ensures adherence to federal or other regulatory requirements. + Assists in the development, implementation and coordination of… more
- Philips (New Kensington, PA)
- …the process, including complaint handling, engineering change orders, kit suppliers, regulatory submissions , and field deployments. + Provides pertinent feedback ... and inspections related to C&R requests, aids in strategy development, oversee regulatory inquiry responses, and reviews these responses to ensure compliance with… more
- Sumitomo Pharma (Harrisburg, PA)
- …and software + Ability to evaluate and write case reports and prepare regulatory submissions + Analytical thinking and attention to detail + Communication ... but not limited to, Clinical Development, Translational Medicine/Early Development, Regulatory Affairs, Data Management and Biostatistics is essential. **Job Duties… more
- Merck (West Point, PA)
- …efficiency and to meet organizational goals. + Preparing/reviewing documentation for regulatory agency submissions , ensuring compliance with industry standards. ... vaccine bioanalytical outsourcing, ensuring alignment with corporate objectives and regulatory requirements. The Senior Director will oversee a multidisciplinary… more
- University of Pennsylvania (Philadelphia, PA)
- … documentation through the IRB, CTSRMC, FDA and all applicable regulatory review committees- including new submissions , continuing reviews, amendments, ... programs and resources, and much more. Posted Job Title Clinical Research Regulatory Specialist B (Abramson Cancer Center) Job Profile Title Clinical Research … more
- Deloitte (Pittsburgh, PA)
- …available Preferred: + Understanding of pharmaceutical regulatory data and regulatory filing requirements and generating submissions packages + Experience ... experience + 4+ years of experience in Life Sciences Pharmaceutical R&D regulatory domain. Experience to include: introducing new technologies like GenAI, AI/ML, and… more
- Highmark Health (Pittsburgh, PA)
- …and regulations; and developing information for reviews, reports, accreditation submissions , regulatory filings and court documents. Responsibilities include ... to identify information to complete work related to reports, accreditation submissions , regulatory filings and court documents. Gathers appropriate documents… more
- University of Pennsylvania (Philadelphia, PA)
- …as well as completion of study related activities including but not limited to regulatory submissions , data entry, and regulatory compliance visits. + Assure ... compliance with the protocol and regulatory requirements includes collecting, recording, and maintaining data and...external auditing, and study close-out visits. + Interface with regulatory authorities (OCR at Penn), Sponsors and any cooperative… more