- US Bank (Oshkosh, WI)
- …and discover what you excel at-all from Day One. **Job Description** The BL Regulatory Review Rep will collaborate with the Quality Review Syndications ... Apps development. Key responsibilities include improving Loan Closing Syndications Quality Review workflow through systems analysis, supporting Power Apps design and… more
- Integra LifeSciences (Princeton, NJ)
- …Document Change Requests, Variances, and other Quality System Documentation that requires regulatory review and approval to ensure compliance with government ... to contribute to establishing labeling requirements per regulations and review labeling that requires regulatory review...per regulations and review labeling that requires regulatory review and approval to ensure compliance… more
- Takeda Pharmaceuticals (Cambridge, MA)
- … Advisor and function as the "R" in the core Medical, Legal, and Regulatory review functions within the Commercial Material Review Process (CMRP). ... to bring life-changing therapies to patients worldwide. The Associate Director, Global Regulatory Affairs Advertising and Promotion (GRA A&P) Review Lead is… more
- Teleflex (Maple Grove, MN)
- …risk activities as well as other deliverables as related to projects. * Provide regulatory review for reporting activities required by EU MDR (ie post-market ... and submissions for complex projects across multiple business units and review issues related to regulatory documents, investigations, product development… more
- Parexel (Providence, RI)
- …related industry experience. * Direct experience in advertising and promotional regulatory review . * Familiarity with FDA regulations governing promotional ... * Track and manage promotional submissions and approvals in regulatory systems * Manage SOPs and electronic review... regulatory systems * Manage SOPs and electronic review systems. Qualifications * Education: Bachelor's degree in Life… more
- University of Pennsylvania (Philadelphia, PA)
- …have oversight of regulatory submissions to the IRB and all applicable regulatory review committees across the portfolio of research undertaken by the ... with internal regulatory groups including the University of Pennsylvania's Institutional Review Board (IRB), the Office of Clinical Research (OCR), and any other… more
- Oracle (Washington, DC)
- …where regulation accelerates - not blocks - innovation **Responsibilities** Key Responsibilities ** Regulatory Review Leadership** + Lead regulatory strategy ... strategies, and post-market surveillance. **Submission Excellence** + Guide development and review of technical files, clinical evidence, and regulatory … more
- University of Pennsylvania (Philadelphia, PA)
- …regulatory documentation through the IRB, CTSRMC, FDA and all applicable institutional regulatory review committees. In collaboration with the Regulatory ... approvals and associated site initiation documentation. Reporting to the Regulatory Affairs New Study & Continuing Review ...the Regulatory Affairs New Study & Continuing Review Manager, the Senior Regulatory Affairs Start-Up… more
- Cleveland Clinic (Weston, FL)
- …accreditation and regulatory standards. + Maintain and regularly update accreditation/ regulatory review plans and strategies. + Work with appropriate ... the world. As a Regional Manager of Accreditation and Regulatory , you will lead and coordinate accreditation and ...accreditation rounding data is trended and made available for review . + Ensure coordination of survey preparation activities and… more
- BeOne Medicines (Emeryville, CA)
- …complaints arise during product lifecycle for the assigned project. + Provide CMC regulatory review for clinical protocols and investigator brochures, etc. for ... **_General Description:_** BeOne is seeking an experienced and energetic regulatory professional to manage, evaluate, and complete regulatory projects consistent… more
- University of Pennsylvania (Philadelphia, PA)
- … documentation through the IRB, CTSRMC, FDA and all applicable regulatory review committees- including new submissions, continuing reviews, amendments, ... and wellness programs and resources, and much more. Posted Job Title Regulatory Affairs Specialist-CC Job Profile Title Clinical Research Regulatory Specialist… more
- Terumo Neuro (Aliso Viejo, CA)
- … strategy for assigned projects and develop approaches to solutions. + Coach, review , and delegate work to junior regulatory affairs professionals; may manage ... processes that span outside of immediate job area. + Write, review , and file regulatory submissions to ensure MicroVention devices are commercially available in… more
- Bristol Myers Squibb (Madison, NJ)
- …required; advanced degree preferred (MS, PhD, PharmD, JD) + Minimum of 3-5 years Regulatory promotional review or related 5 to 8 years pharmaceutical experience ... personal lives. Read more: careers.bms.com/working-with-us . **Associate Director Commercial Regulatory Affairs** **Description** : The role of Associate Director of… more
- Lilly (Philadelphia, PA)
- …for investigational and commercial radiopharmaceutical products. + Lead global CMC regulatory submissions including authoring, review , and finalization + Lead ... and contribute to responses to regulatory agency questions globally + Review change controls to assess country-specific CMC regulatory impact + Review … more
- Terumo Neuro (Aliso Viejo, CA)
- …execute the regulatory strategy for the assigned market(s). + Write, review , and file regulatory submissions to ensure MicroVention devices are commercially ... consolidate, and maintain verbal and written communication with the regulatory agencies. + Review change order documents and assess regulatory impact… more
- Parexel (Nashville, TN)
- …data entry and validation in Veeva Vault RIMS for submissions and approvals. Regulatory Submissions * Review , prepare, and submit dossiers; negotiate with HAs ... Bring your expert knowledge of FDA regulatory requirements and guidelines to Parexel! We are currently seeking a highly motivated Regulatory Affairs professional… more
- Grifols Shared Services North America, Inc (San Diego, CA)
- …mitigation plans, lead mitigation projects, and make decisions that will assist in reducing regulatory risk. + Review , provide regulatory input to, and ... management system related documents including utilizing scientific concepts to critically review complex reports, validations, etc. to ensure regulatory … more
- Boehringer Ingelheim (St. Joseph, MO)
- … regulatory issues. + Facilitate partnerships, both formal and informal, with key regulatory agency review staff. + Participate in due diligence processes by ... **Description** Manager The Manager, Regulatory Affairs (RA) Pharma Safety & Efficacy will...sufficient and efficient communication through activities such as governance review , project team meetings, planning activities and FDA communications.… more
- Philips (New Kensington, PA)
- …assessments, health hazard evaluations, corrections and removals and CAPAs as a regulatory SME. + Review labeling, marketing materials, and claims substantiation ... The Principal Regulatory Affairs Specialist will develop and execute the regulatory strategy for new product development, design changes, and field safety… more
- UPMC (Pittsburgh, PA)
- …and other regulatory bodies. * Collaborate with accreditation and regulatory specialists: Review work plans, identify growth opportunities, and meet ... Join a dynamic team dedicated to advancing stroke and regulatory care. As an Improvement Specialist, you'll lead stroke-related initiatives while supporting broader … more
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