- Insmed Incorporated (San Diego, CA)
- …multiple phases of clinical research (Phase 1-3)Knowledge of ICH-GCP and FDA regulatory guidelinesDomestic and/or International travel required 20%Travel ... & interpretation of clinical trial data, authoring clinical study and regulatory communications and documents, and monitoring of competitor activities and data.… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …within the organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education ... & conduct of clinical trials In-depth knowledge & direct experience/interactions with the FDA (or equivalent regulatory authority) in relation to the design,… more
- Aequor (Chattanooga, TN)
- …(SOP's), Good Manufacturing Practices (GMP) Compliance, and Food and Drug Administration ( FDA ) regulatory standards. Maintain compliance with all state and ... Peer Relationships, Directing Others, and Comfort Around Higher Management o Experience in Food or Pharma manufacturing following FDA regulations is preferred. more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …within the organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...product and establishment registrations (drug/establishment listings) and submission to FDA databases. This individual acts as the Subject Mater… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …tracks regulatory trends, legislative changes, and guidelines issued by global regulatory agencies ( FDA , EMA, MHRA, etc.) related to CSPV. Participates in ... in associated contractual templates. Ensures Good Pharmacovigilance Practice and regulatory compliance in such arrangements. Oversees Local/Global Pharmacovigilance (PV)… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …manage multiple complex tasks or projects Strong knowledge and experience implementing FDA and EMEA Regulatory automation requirements Knowledge of AutoCAD ... the BMS system throughout the component and software lifecycle Provide input during regulatory inspections of BMS and relevant projects as needed Work with the… more
- Merck & Co. (Durham, NC)
- …development, validation, and/or technology transfer.Experience authoring technical documents supporting regulatory filings ( FDA , EMA, JNDA).Knowledge of CFR, ... and techniques as they relate to laboratory testing start-up, regulatory requirements for method transfer/validation project timelines and budgetingBuild knowledge… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …equipment is maintained to meet GMP requirements.Support utilities areas in Regulatory / FDA inspections ensuring successful outcomes.Cross functional ... standards, Occupational Safety and Health Administration (OSHA) standards, other regulatory agency standards, and good maintenance practices.Support facilities, utilities,… more
- Merck & Co. (Rahway, NJ)
- …phase drug product manufacturing processes to GMP production facilities.Experience authoring regulatory filings, and demonstrated working knowledge of FDA , ICH, ... packaging, compatibility characterization for processing and administration, and supporting regulatory filings.Collaborate with key stakeholders across the organizations (Research… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …partnering with FDA . This role will create and implement effective regulatory strategies to deliver on efficient and robust development plans. The individual ... US regulatory strategy for assigned project(s).Strategize and plan for FDA meetings for assigned product. Liaise, negotiate and orchestrate meetings with … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …partnering with FDA . This role will create and implement effective regulatory strategies to deliver on efficient and robust development plans. The individual ... will direct, coordinate and implement the preparation of US regulatory submissions and provide US regulatory support... strategy for assigned project(s). Strategize and plan for FDA meetings.Serve as the primary contact with FDA… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …partnering with FDA . This role will create and implement effective regulatory strategies to deliver on efficient and robust development plans. The individual ... provide US regulatory support; meet aggressive deadlines to ensure that FDA receives timely and quality submissions, shortening the review process and leading to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Experience Qualifications7 or More Years in the pharmaceutical industry4 or More Years in regulatory affairs, NDA, sNDA, BLA filing to FDA Travel Ability to ... diseases and immune disorders. Summary Effectively liaise, negotiate and partner with FDA ; direct, coordinate and implement the preparation of all regulatory … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …DSUR, IND/NDA/BLA annual reports, BTD request etc.)Develops less complex Module 1 regulatory documents (eg cover letter, FDA forms, administrative information, ... centered around rare diseases and immune disorders. Summary: The Associate Director, Regulatory Affairs - Regulatory Project Management (RPM) provides planning… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational leadership on product ... labeling in collaboration with Global Regulatory Leads (GRLs). This position may serve as an...cross functional teams through all labeling discussions with the FDA /CHMP while ensuring management alignment. Strategizes and plans for… more
- Aequor (Thousand Oaks, CA)
- …experience managing implementation of Quality Management System Requirements, Product Standards / Regulatory Requirements (eg FDA CFRs for Biologics and Medical ... Devices, FDA Combination Product Regulation, ISO:13845, EU Medical Device Directive, EN 60601and IEC/EN 62304) Experience supporting pre-clinical, clinical research, and/or pharmacovigilance activities Ability to read, analyzes, and interprets general… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …within the organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...critical CMR training documentation Ensures training and compliance to FDA Regulations, ICH Guidelines, and GCPs governing the conduct… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …within the organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...The Position Reporting to the head of Clinical, medical, Regulatory (CMR) Business Operations, the Associate Director (AD) is… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …within the organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...requires strong collaboration with stakeholders across Clinical Medical and Regulatory (CMR), including the NACO senior leadership team and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …within the organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...across CDSE and more broadly within Clinical, Medical and Regulatory , Market Access and Public Affairs. Externally, this individual… more
Related Job Searches:
FDA,
FDA Regulatory Compliance Manager,
FDA Regulatory Drug,
FDA Regulatory Quality,
Healthcare FDA Regulatory,
Regulatory,
Regulatory Compliance FDA