- Insmed Incorporated (San Diego, CA)
- …Workplaces for Women™, Best Workplaces for Millennials™, and Best Medium Workplaces™ lists.OverviewThe Director , Regulatory Affairs will serve as the ... lead the central messaging, preparation, and submission of high quality , regulatory complaint regulatory dossiersDirect...communicate issues, outcomes, and risks to the VP of Regulatory Affairs and relevant teamsWith oversight from… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …toward building a quality mindset with Medical Affairs .Support the Sr. Director 's Medical Affairs Quality strategy by partnering with members and ... the Quality organization at senior levels. The Director plays a pivotal role in regulatory ...Access Programs.Collaborate with the Sr Director , Medical Affairs QA to conduct quality reviews of… more
- Lundbeck (North Hyde, SD)
- Lundbeck Australia is currently seeking a highly motivated and experienced Regulatory Affairs Manager to lead and manage regulatory activities across our ... regulatory submissions, maintaining licences and liaising with government authorities.The Regulatory Affairs Manager plays a critical part in ensuring… more
- Merck & Co. (Rahway, NJ)
- …we operationalize CMC. This individual will be a senior member of the Regulatory Affairs CMC organization and will also manage significant cross-modality ... projects as an extension of the overall Regulatory Affairs CMC Leadership Team.-This Lead plays...are in place to maintain the scientific, technical and regulatory quality of all CMC submissions, correspondence,… more
- Merck & Co. (Montgomery County, PA)
- …the Pipeline Advertisemen We are currently recruiting for several Associate Director positions within US Marketing, covering Physician (HCP), Consumer (HCC), ... collaborating across multiple stakeholders (including sales, marketing operations, Legal, Regulatory , Medicals, etc.) to drive promotional execution. This AD will… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …(eg SOPs) as appropriate.Collaborate with cross-functional teams (eg, Medical Safety, Regulatory Affairs , Epidemiology) to ensure benefit-risk integration to ... activities and fosters a culture that seeks to constantly enhance global regulatory compliance to meet signal evaluation timelines.Develop quality systems and… more
- Insmed Incorporated (San Diego, CA)
- …with the Biometrics teams, Clinical Operations teams, Clinical Development teams, Regulatory Affairs , and external partners.ResponsibilitiesEDC System Design & ... solutions comply with GCP, 21 CFR Part 11, and CDISC ODM StandardsData Quality & Compliance:Ensure EDC systems comply with regulatory requirements (eg, FDA,… more
- Eisai, Inc (Nutley, NJ)
- …difference. If this is your profile, we want to hear from you. The Director , US HEOR and RWE (field) is responsible for developing HEOR engaging population-based ... research activities and development of external communication materials. The Director facilitates coverage, reimbursement and appropriate utilization based on… more
- Merck & Co. (Millsboro, DE)
- …Quality Notifications and technical documentation; collaborate cross-functionally with QA, Regulatory Affairs , EHS, Engineering, BTS, ATS and HR.Direct ... leaders and frontline teams, and who works effectively across functional partners. Quality - and compliance-focused with practical experience supporting regulatory … more
- Lupin Pharmaceuticals (Coral Springs, FL)
- …or fellowship in a related field.Proven leadership abilities, strong knowledge of regulatory frameworks (eg, FDA), GCP guidelines, and quality management ... target product profile (TPP) development, due diligence projects, and clinical- regulatory compliance. ResponsibilitiesEssential Duties and Responsibilities Clinical Development: Design… 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
- Mohawk Valley Health System (Utica, NY)
- Sr Director Quality Management & Regulatory Affairs - Full Time - Days Department: QUALITY IMPROVEMENT Job Summary The Senior Director of ... throughout the organization. The Senior Director of Quality Management Systems & Regulatory Affairs is accountable for developing, leading, and… more
- Kelly Services (Anaheim, CA)
- ** Director of Quality and Regulatory Affairs ** Kelly(R) Science & Clinical is seeking a ** Director of Quality and Regulatory Affairs ** ... In this role, you will be responsible for developing, coordinating, and implementing quality and regulatory strategies and programs required for the development,… more
- Merck (Rahway, NJ)
- …Process Owner for one or more of the QMS processes managed under GRACS(Global Regulatory Affairs & Clinical Safety) Quality &Compliance. + Establishes and ... as a Subject Matter Expert (SME) for functional group processes, systems, and regulatory knowledge. + Applies capabilities to enhance quality and builds… more
- LifeCenter Northwest (Bellevue, WA)
- …the initiatives are carried out to achieve KPI's. + Collaborates with the Director , Quality & Regulatory Affairs (QRA) to collect and analyze the data ... Director , Referral Optimization Job Details Job Location Bellevue...continuous improvement that values learning and a commitment to quality . + Develops and implements training plans for all… 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
- 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
- Sanofi Group (Cambridge, MA)
- **Job Title:** Director , Global Regulatory Affairs - Global Labeling Strategy **Location:** Morristown, NJ Cambridge, MA **About the Job** Are you ready to ... be critical in helping our teams accelerate progress. The Director , Global Regulatory Affairs -...consideration of patient experience data (eg, Patient Report Outcomes, quality of life measures). This strategic input ensures alignment… more
- Boehringer Ingelheim (Athens, GA)
- …and benefit programs reflect Boehringer Ingelheim's high regard for our employees. The Director , US Regulatory Affairs Pharmaceuticals leads the US ... Management of existing products in accordance with company priorities and governance. The Director , US Regulatory Affairs Pharmaceuticals is a key interface… more
- Chemours (Providence, RI)
- …living depend on Chemours chemistry. Chemours is seeking a ** Director of Regulatory Advocacy** to join our growing Government Affairs team! This position ... Affairs Group with a primary responsibility for supporting US federal regulatory affairs engagement with the United States Environmental Protection Agency… more
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