- Insmed Incorporated (San Diego, CA)
- …solving and issue resolution, etc.Develop risk mitigation plans for key partnersProvide regulatory review of documentation prepared by other technical functions ... and for the future of science, we're in. Are you?About the Role:The Director, Regulatory Affairs will serve as the regulatory leader on cross-functional teams,… more
- Insmed Incorporated (NJ)
- …CMC meetings with the regulatory agencies, and draft and review regulatory documents for agency meetings.Provide interpretation of applicable FDA/EMA/ICH/WHO ... Role:This position is a key role that will provide regulatory CMC (RA CMC) leadership and strategy to achieve... CMC (RA CMC) leadership and strategy to achieve regulatory approvals in various countries. As a strategic function,… more
- Insmed Incorporated (NJ)
- …product development and submission activities. The GRL will serve as the global regulatory lead for documentation review prepared by other technical functions ... for the future of science, we're in. Are you?About the Role:The Global Regulatory Lead (GRL) will be responsible for formulating and implementing global … more
- Cipla (Hauppauge, NY)
- …that batch records and audit trails are readily accessible and properly formatted for regulatory review . Assist in the training of staff on proper documentation ... that all system actions are secure, traceable, and compliant with regulatory standard. Review of the batch records (manufacturing and packaging) to ensure… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …internal workflows and performance metrics to ensure departmental KPIs and regulatory compliance are consistently met Implement Medical Review Prospective ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...& Retrospective Quality Review of cases Regulatory Intel & Inspection Readiness Maintains up to date… more
- USAA (San Antonio, TX)
- …NC. Relocation assistance is not available. What you'll do: Prepare and review regulatory reports and underlying work-papers and calculations for accuracy ... you will serve as a key contributor in the preparation, review , and analysis of reports compiled for regulatory agencies to include the FR Y-9C, FR Y-9LP, FR… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …support Compliance initiatives, such as inspection readiness, metrics implementation and review , overall regulatory compliance and implementation programs, and ... global quality organization to ensure harmonization, alignment and execution of regulatory guidelines across all manufacturing areas, supporting both clinical and… more
- Aequor (Fort Worth, TX)
- …standard quality control operating procedures. Supply quality control data necessary for regulatory submissions. Receive and inspect raw materials. Review data ... from contract laboratories to ensure accuracy and regulatory compliance. Prepare or review required method transfer documentation including technical transfer… more
- Aequor (Fort Worth, TX)
- … Review data from contract microbiology labs to ensure accuracy and regulatory compliance. Prepare or review method transfer documentation for biological ... microbiological quality control. Supply biological quality control data necessary for regulatory submissions. Receive and inspect biological raw materials (eg, cell… more
- City National Bank (Phoenix, AZ)
- …mitigation strategies to address gaps in control design or operating effectiveness Review and challenge regulatory remediation activities in assigned coverage ... and Payment Systems, the Fraud Manager II will contribute to the ongoing review and monitoring of operational risk programs executed by assigned 1LOD business or… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- 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
- Merck & Co. (Rahway, NJ)
- …agencies, or investigators.-10. Responsible for ensuring the accuracy of Statistical Review Aids submitted to regulatory agencies.11. Participates with ... art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for… more
- West Coast University (Anaheim, CA)
- …and local laws/regulations relating to programs, governmental compliance, and other regulatory standards such as ABHES, BVNPT, BRN, and other accreditation ... standards. Experience: ATI product experience. A minimum of one to two years of professional testing and/or statistical data experience involving database management. Experience working with nursing programs. Experience with Blackboard Learning Management… more
- Insmed Incorporated (NJ)
- …commitment to working closely with patient community preferredFamiliarity/experience with regulatory and pharmaceutical legal promotional review processesA track ... and cross-functional partners, including ex-US colleaguesWork closely with Legal, Regulatory , Compliance, Medical Affairs, Market Access, and Commercial Operations… more
- Insmed Incorporated (NJ)
- …a start-up and/or mid-cap sized company highly desiredFamiliarity/experience with regulatory and pharmaceutical legal promotional review processesSuccessful ... Supply, Global Brand Strategy Team, etc)Work closely with Legal, Regulatory , Compliance, Medical Affairs, Market Access, Advocacy, and Commercial Operations… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …campaign development to drive market share and revenue growth. Partner with legal, regulatory , and medical affairs for timely review and approval of promotional ... including sales, marketing, medical affairs, market access and policy/advocacy (MAPA), regulatory affairs, and other relevant NNI departments to ensure alignment of… more
- Eisai, Inc (Orlando, FL)
- …including training, career evaluation, coaching, mentoring, performance management and talent review . Ensure compliance with regulatory and other ethical ... of the FDA, OIG, HIPPA, PhRMA, GCP and other international regulatory /ethical guidelines relevant to the pharmaceutical industry & clinical trial conduct,… more
- Merck & Co. (Millsboro, DE)
- …Quality Specialist ensures product/process quality system adherence and batch record review , completes quality checks and SAP transactions required to release ... and works in a team environment to ensure timely review and documentation is Right First Time. The successful...to cGMPs and is knowledgeable in federal and other regulatory agency requirements and other regulatory agency… more
- Merck & Co. (Rahway, NJ)
- …Source Management Business Operations Lead is expected to understand the end-to-end regulatory submission process. The main focus will be on document production ... processes, including content authoring, review and finalization, and feed to the Submissions Assembly...industry experience, at least 6 of those in a regulatory and/or compliance area and experience with technical systems… more
- Insmed Incorporated (NJ)
- …This individual will provide scientific support to clinical development and operations, regulatory and quality assurance teams, as well as overall program support ... Collaborate with internal teams, CROs, and external vendors to prepare, review , and finalize clinical protocol documents.Contribute to scientific and operational… more
Related Job Searches:
Associate Regulatory Review,
Associate Regulatory Review Multiple,
Business Line Regulatory Review,
Regulatory,
Regulatory Review Analyst,
Regulatory Review Compliance Inspector,
Regulatory Review Compliance Medical,
Review,
Senior Associate Regulatory Review,
Senior Manager Regulatory Review