- Insmed Incorporated (NJ)
- …degree (MS, PhD, PharmD) strongly preferredMinimum of 5 years of experience in Regulatory Affairs , with hands-on experience in regulatory submissions across ... submissionsProvide oversight for preparation and delivery of materials for regulatory agency meetingsPrepare and deliver high- quality presentations for both… more
- Insmed Incorporated (NJ)
- …of IT projects within defined scope, budget, and timelineWork closely with Medical Affairs and other support functions (eg Quality Assurance, Compliance, Legal, ... in IT with focus on healthcare/pharmaceutical industryExperience with medical affairs processes and regulatory environmentsStrong technical knowledge of… more
- Insmed Incorporated (NJ)
- …expand what's possible for patients with serious diseases. Reporting to the Associate Director , Regulatory Affairs , Tactical Implementation, you'll have a ... in. Are you?About the Role:We're looking for a Manager, Regulatory Affairs , Tactical Implementation, on the ...programs and market. Under the guidance of the Associate Director , you will ensure high- quality , timely, and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Serve on Local Labeling Committee (LLC) and provide medical input to Regulatory Affairs Physical Requirements 20-30% overnight travel required. 30% overnight ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...Area in certain instances, at the discretion of Executive Director of Medical Affairs . Assists the Senior… more
- Eisai, Inc (Baltimore, MD)
- …implement recommendations for resolution.Certification is a plus (such as Regulatory Affairs Professional Society (RAPS)Technical Skills RequiredAdvance working ... vendor management, and technical oversight to support the objectives of Global Regulatory Operations. The Associate Director will collaborate with the Heads… more
- Bayer (Whippany, NJ)
- …or biological regulated environment within a regulated function which may include, Medical Affairs , Quality , Safety, or other similar area is required; Strong ... make a real difference, there’s only one choice. Senior Director , Digital Governance & LMR Lead The Senior ...years in a regulated function which may include, Medical Affairs , Quality , Safety, or other similar area;… more
- Insmed Incorporated (NJ)
- …Are:You have a Bachelor's degree along with 5+ years of experience in Medical Affairs , Regulatory Affairs , or related functions within the pharmaceutical or ... will ensure efficient coordination of MRC activities, compliance with company policies and regulatory standards, and the quality and integrity of all reviewed… more
- Insmed Incorporated (NJ)
- …development team, partnering closely with heads of clinical operations, toxicology, regulatory affairs , commercial, pharmacovigilance, clinical quality , and ... of science, we're in. Are you?About the Role:We're looking for an Executive Director , Clinical Development - Neurology to help us expand what's possible for patients… more
- Cipla (Fall River, MA)
- …management committee, commercial, portfolio, R&D technical staff, supply chain management, medical affairs , regulatory affairs , quality assurance, ... management. In collaboration with Cipla commercial, supply chain management and regulatory affairs , responsible for launch planning, launch risk mitigation… more
- Novo Nordisk Inc. (Seattle, WA)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Novo Nordisk Inc. (New Orleans, LA)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Kemin Industries (Des Moines, IA)
- Overview Kemin Health is hiring an Associate Director of Regulatory /Scientific Affairs and Quality ! In this role, you will be responsible for leading the ... business units' regulatory affairs (RA) and quality assurance (QA) teams by proactively identifying and managing regulatory / quality risks and… more
- Unilever (Austin, TX)
- …we'd love for you to be part of it. **JOB SUMMARY** The Senior Director , Quality Assurance and Regulatory Affairs will lead the company's quality ... for developing and executing quality systems through the electronic Quality Management System (eQMS), overseeing audits and regulatory inspections, and… more
- Kelly Services (Dallas, NC)
- … Regulatory Affairs Associate supports the Quality Assurance & Regulatory Affairs Director in ensuring company-wide compliance with regulatory ... Affairs Associate** **Location:** Dallas, NC **Department:** Quality Assurance & Regulatory Affairs **Reports To:** Director , Quality Assurance & … more
- University of Colorado (Aurora, CO)
- …for improvement (OFI) through audits and occurrence reports to the Director of Regulatory Affairs and/or Quality Manager, which are then shared with ... healthcare-related experience. + Two (2) - four (4) years of related quality assurance and regulatory affairs experience in a clinical laboratory. + MT(ASCP)… more
- Eurofins US Network (Centennial, CO)
- …the DPT network of laboratories. Under the direction of the Director of Regulatory Affairs and Quality Assurance, this position, in tandem with RA/QA ... vendors, clients and auditors. + Performs duties in compliance with all applicable regulatory and accrediting agencies. + Supports the Director of RA/QA in… more
- Boehringer Ingelheim (St. Joseph, MO)
- …as governance review, project team meetings, planning activities and FDA communications. Associate Director Act as Regulatory Affairs (RA) core or subteam ... **Description** Manager The Manager, Regulatory Affairs (RA) Pharma Safety &...governance model to drive Research Profile/Target Product Profile and Quality Target Profile. + Provide consistent regulatory … more
- Emory Healthcare/Emory University (Atlanta, GA)
- …leadership programs + And more **Work Location:** Atlanta, GA **Description** The Corporate Director of Regulatory Affairs is an operational leader ... activities and readiness across the health system. The Corporate Director of Regulatory Affairs ensures...Minimum of 8 - 10 years of experience in regulatory affairs , healthcare quality , or… more
- Astellas Pharma (Northbrook, IL)
- …work are encouraged to apply. **Purpose and Scope:** We are seeking an experienced CMC Regulatory Affairs Director with deep expertise in the United States ... with local and global stakeholders (eg, Product Development & Manufacturing, Regulatory Affairs , Quality Assurance, Business Partners). Responsible… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …learn, grow and become your best self. Become a **maker of possible** with us. Director of Regulatory Affairs is responsible for developing and implementing ... the Sr Director Regulatory WWIPD, Regulatory strategies to enhance product quality design,...with US and international laws and regulations + Manage Regulatory Affairs platform and leads a team… more
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