- Grant Thornton (Charlotte, NC)
- As a Regulatory & Practice Review Seasonal Senior Manager you'll support audit teams for regulatory inspection with all with the resources, environment, and ... day-to-day may include: + Supporting audit teams that are selected for regulatory inspection + Communicating and interaction with the firm's regulators + Conducting… 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
- Chiesi (Boston, MA)
- …quo for the better. Who we are looking for Purpose Responsible for the regulatory review and submission of advertising and promotional materials for multiple ... Ensures appropriate implementation of Chiesi Global Rare Disease procedures for the regulatory aspects of labeling preparation, launch prep, review , approval,… more
- Teleflex (Morrisville, NC)
- …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
- Actalent (Irvine, CA)
- …submission packages for regulatory agencies. + Track the status of applications under regulatory review and provide updates to the regulatory team. + ... and linkage to training records where applicable. + Support regulatory submissions for medical devices. + Review ...Support regulatory submissions for medical devices. + Review design changes. + Provide tech file support. Essential… 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
- 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
- NextEra Energy (Jupiter, FL)
- …guidelines + Prepare reports outlining the exam content and development activities for regulatory review and approval + Provide guidance and support to training ... ** Regulatory Exam Author Principal** **Date:** Dec 10, 2025...nuclear power plants. **Job Duties & Responsibilities** + Create, review , and revise examination questions and test materials that… 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 (San Mateo, 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
- Oracle (Bismarck, ND)
- …compliance is a plus. Experience preparing for audits or building evidence packages for regulatory review . Join us to ensure our healthcare technology meets the ... **Job Description** This role is dedicated to understanding healthcare regulatory requirements (such as HIPAA, HITRUST, FDA, etc.) and guiding cross-functional teams… 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
- 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
- Fifth Third Bank, NA (Cincinnati, OH)
- …standards issued by the regulatory agencies for accurate completion of regulatory reports. + Review completed reports for technical accuracy, completeness ... projects and to seek automation in the reporting process. + Review technical regulatory subject matter to serve as the organization's Regulatory … 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
- 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
- BD (Becton, Dickinson and Company) (Milpitas, CA)
- …development teams. + Evaluate design, manufacturing, and process changes for global regulatory impact. + Review analytical and clinical protocols to ensure ... **Job Description Summary** We are seeking a Senior International Regulatory Affairs Specialist to join our Regulatory ...appropriate data collection for submissions. + Review and approve product labels, labeling, and promotional materials… 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
- 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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