- Merck & Co. (Rahway, NJ)
- …Combinations CMC (Chemistry, Manufacturing & Controls), you will report to the Director of Device Regulatory Affairs for Autoinjector Development Programs. You ... will spearhead regulatory activities for Devices and Drug-Device Combinations (DDDC), ensuring...accuracy and completeness of submissionsPartner with Device Development, Device Quality , and other Drug stakeholders to communicate and align… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. Summary The Associate Director of Regulatory Writing is a key role responsible for producing ... scientifically accurate, high- quality clinical ...strategic insights at the study team level. The Associate Director of Regulatory Writing must possess advanced… more
- Merck & Co. (Rahway, NJ)
- …Clinical Safety , including training process standards and strategies to ensure optimal quality and compliance in Global Regulatory Affairs and Clinical Safety ... Job DescriptionThe Global Regulatory Affairs and Clinical Safety Global Process Lead...Process Lead is responsible for overseeing and managing Global Regulatory Affairs & Clinical Safety global business processes. This… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … support across all global projects; meet aggressive deadlines to ensure that regulatory agencies receive timely and quality submissions, shortening the review ... and partnering with FDA. This role will create and implement effective regulatory strategies to deliver on efficient and robust development plans. The individual… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … support across all global projects; meet aggressive deadlines to ensure that regulatory agencies receive timely and quality submissions, shortening the review ... and partnering with FDA. This role will create and implement effective regulatory strategies to deliver on efficient and robust development plans. The individual… more
- Merck & Co. (Lower Gwynedd, PA)
- …improvement.Direct support of validation activities and all other associated Quality functionsUnderstands and applies regulatory /compliance requirements relative ... Discovery, Preclinical and Translational Medicine Operations (DPTM) is seeking an Associate Director to lead the Molecular lab within the Late Development (AdVAnce)… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …rare diseases and immune disorders. Summary: This role is responsible for providing regulatory strategic and tactical leadership, and alignment to ways of working on ... and partnering with FDA. This role will create and implement effective regulatory strategies to deliver on efficient and robust development plans. The individual… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …cooperation of others (team members); meet aggressive deadlines to ensure that regulatory agencies receive timely and quality submissions, shortening the review ... and partner with FDA; direct, coordinate and implement the preparation of all regulatory submissions and provide regulatory support across all global projects,… 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 ad hoc member of Global Project Team (GPT) to address labeling issues… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- Position SummaryThe Quality Director is the senior leader and decision maker for the Quality Department and Quality Management System. This position is ... customer and the quality system integrity expected by the customer. The Quality Director is committed to relentlessly pursuing zero defect manufacturing and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …the organization and contact volume grows. Relationships Reports to the Sr. Director , Patient Support Solution Quality /Safety Associate Director . Interacts ... Quality , NNI IT and Telephony, Medical Information, Compliance, Regulatory , Legal and Privacy. External relationships include Patient Support program vendors… more
- Merck & Co. (Rahway, NJ)
- …multidisciplinary team environment with key stakeholders across the organizations such as Quality , Regulatory CMC, and technical functions, to ensure timebound ... of integration and partnering for Pharmaceutical development/ CMC with Quality , Regulatory , Operations, Non-clinical, Clinical, and other functional… more
- Merck & Co. (Rahway, NJ)
- …of integration and partnering for Pharmaceutical development/ CMC with Quality , Regulatory , Operations, Non-clinical, Clinical, and other functional ... oral and non-oral portfolio. Within Biologics and Biopharmaceutics, the Biopharmaceutics Director will influence the strategy, lead activities, and develop a team… more
- Merck & Co. (Rahway, NJ)
- …and Regulatory in aspects of control strategy and filings, Quality and our partners in the commercialization and manufacturing division.This challenging position ... biochemical processes, parenteral, oral, and specialty dosage formulations.- The director should be well engaged with regulatory ...The director should be well engaged with regulatory and industry trends to guide future activities for… more
- Merck & Co. (Rahway, NJ)
- … of GMP Operations, will oversee laboratory compliance across multiple sites, managing regulatory audits, internal quality and safety audits, quality ... GMP Operations team.Ensure inspection readiness and offer prompt support during regulatory , quality , and safety inspections.Address audit findings and identify… more
- Merck & Co. (Rahway, NJ)
- …CMC and Regulatory in aspects of control strategy and filings, Quality and our partners in the commercialization and manufacturing is essential.The successful ... and retaining diverse talent.Extensive knowledge of and hands-on work in applying regulatory guidance and quality standards related to product release and… more
- Merck & Co. (Millsboro, DE)
- …(USDA, DEA, DNREC, etc.) of animal facilities and program reviews is required.PurposeThis Associate Director will report to the Site Quality Head/ Director of ... Job DescriptionOur company seeks to add an Associate Director . Veterinarian Services at our Millsboro, Delaware location. This position will have overall… 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 health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …make a difference? The Position Reporting to the head of Clinical, medical, Regulatory (CMR) Business Operations, the Associate Director (AD) is responsible for ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...find better and more innovative ways to improve their quality of life. We're changing lives for a living.… more
- Merck & Co. (Lower Gwynedd, PA)
- …Metabolism, and Bioanalytics (PDMB) Regulated Bioanalytics Department is seeking a Senior Director to lead the Regulated Robotics & LIMS team within the Exploratory ... vaccines and enable late-stage clinical trials through the generation of timely, high- quality regulated bioanalytical data. As the AdVAnce facility will not be fully… more
Related Job Searches:
Director,
Director Quality,
Director Quality Assurance Regulatory,
Director Quality Regulatory Compliance,
Director Regulatory Affairs Quality,
Global Director Quality Regulatory,
Project Director Quality Regulatory,
Quality,
Regulatory,
Regulatory Director