- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as other research areas centered around rare diseases and immune disorders. Summary: The Associate Director, Regulatory Affairs - Regulatory Project ... provides planning and drives coordination of global and US regulatory activities. The Associate Director RPM is...provides impactful contributions to the RPM group and the regulatory affairs organization by identifying gaps in… more
- Merck & Co. (Lower Gwynedd, PA)
- …The Discovery, Preclinical and Translational Medicine Operations (DPTM) is seeking an Associate Director to lead the Molecular lab within the Late Development ... utilized to generate pivotal safety and efficacy clinical patient data required for regulatory filings. As the AdVAnce facility will not be fully constructed and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Years pharmaceutical industry experience required4 or More Years of direct regulatory affairs experience, including US labeling experience requiredExperience ... This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational leadership on product… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …or More Years in the pharmaceutical industry preferred1 or More Years in regulatory affairs requiredExperience in (s)NDA/BLA filing to FDA preferred Travel ... with FDA. This role will create and implement effective regulatory strategies to deliver on efficient and robust development...will direct, coordinate and implement the preparation of US regulatory submissions and provide US regulatory support… more
- Genmab (Plainsboro, NJ)
- …information) for the Genmab portfolio of products. This role will be within Global Regulatory Affairs (GRA) and will report to the Sr Director, Labeling, Policy ... best, and authentic is essential to fulfilling our purpose.The RoleThe Global Regulatory Labeling Strategy Sr Manager/ Associate Director will be responsible for… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …number of stakeholders across CDSE and more broadly within Clinical, Medical and Regulatory , Market Access and Public Affairs . Externally, this individual is ... cross-functional teams, including members of the CDSE team, clinical development, medical affairs , regulatory , and commercial, to facilitate the integration of… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Expert understanding of the pharmaceutical industry including marketing, medical, access, public affairs , compliance, legal and regulatory as well as the ... collaborators, as we embark on shaping our future. The Position The Associate Director, HCP Experience has overall strategic and operational responsibility as well… more
- Merck & Co. (North Wales, PA)
- …and systems for a pharmaceutical company, ensuring compliance with regulatory requirements and maintaining high-quality standards.- Product managers must possess ... teams to develop and implement pharmacovigilance strategies that meet regulatory requirements and ensure patient safety, quality and compliance.-Oversee PV… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to Clinical Operations, Clinical Development, Biostatistics and Data Management, Regulatory Affairs , Quantitative Clinical Pharmacology, Clinical Safety and ... Pharmacovigilance, Regulatory /Risk Management, Quality Assurance, Medical Affairs , Translational Research, Research, Informatics Services, Project Management and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders.Summary: The Associate Director, Regional Marketing Conventions & Field Programs will be ... and more, while ensuring adherence to DS policies and procedures. The Associate Director, Regional Marketing Conventions & Field Programs is responsible for managing… more
- Merck & Co. (Rahway, NJ)
- …with a cross-functional Senior/ Executive Director group of experts in commercialization, regulatory affairs , statistics, medical affairs and manufacturing ... teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs and new indications for existing products. We… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Board, Patient Marketing, Managed Markets, Trade, Corporate Communications, Legal, Regulatory , Medical Information and Medical Affairs . External relationships ... planning and execution to assigned Novo Nordisk, Inc. therapeutic areas. Assist Associate Director with development and execution of annual strategic convention plan… more
- Merck & Co. (Rahway, NJ)
- …Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... pursue and subsequent study design, initiation, execution, monitoring, analysis, regulatory filing, and publication. Specifically, The Senior Clinical Director May… more
- Englewood Lab, Inc (Totowa, NJ)
- Title: Regulatory Affairs Associate Reports to: Manager of Regulatory Affairs Department: Quality/ Regulatory Responsibilities: + Assist the ... Manager of Regulatory Affairs to create and collate product master files (dossiers),...ISO 13485:2003, COSMOS/ECOCERT, etc). + Assist the Manager of Regulatory Affairs for facility registrations, renewals, and… more
- ManpowerGroup (Overland Park, KS)
- HIRING a Regulatory Affairs Associate for a **global** **leading Clinical Research Organization** This is a **fully REMOTE** **(EST/CST only) opportunity ... on** **W2** **or C2C** **.** Looking for an experienced associate mostly worked on **CTA(clinical trial applications** ). The...members of the team are a senior director of regulatory affairs and a CMC Health person.… more
- Kemin Industries (Des Moines, IA)
- Overview Our Food Technologies team is hiring a Regulatory Affairs Associate ! In this role, this person will be responsible for preparing regulatory ... the databases and trackers in real time. This person may also represent Regulatory Affairs on project teams, as more experience is acquired. This role will… more
- Dorsey & Whitney LLP (Minneapolis, MN)
- Regulatory Affairs Associate (#918) - Minneapolis Dorsey & Whitney LLP is seeking an associate with two to five years of environmental, natural ... or regulatory law experience to join the Regulatory Affairs Practice Group in our Minneapolis...in salary. Associates are eligible to participate in Dorsey's associate bonus program, subject to the program's conditions and… more
- Dorsey & Whitney LLP (Anchorage, AK)
- Regulatory Affairs Associate (#856) - Anchorage Dorsey and Whitney LLP is seeking a Regulatory Affairs Associate with four to six years of ... experience to join the Anchorage office. This associate will have the opportunity to work on a wide variety of issues and matters, including corporate and municipal… more
- Colgate-Palmolive (Piscataway, NJ)
- …goals. Together, let's build a brighter, healthier future for all. **Scope:** The Regulatory Affairs Associate Manager supports Colgate's Oral Care and ... or a related field. * Minimum 5 years of experience in regulatory affairs within the consumer goods or pharmaceutical industry. * Comprehensive knowledge of… more
- Sumitomo Pharma (Columbus, OH)
- …currently seeking a dynamic, highly motivated, and experienced individual for the position of ** Associate Director, Regulatory Affairs ** . The Associate ... Director is part of the Global Regulatory Affairs (GRA) team based in the US. He/she will...pharmaceutical industry with minimum of 6 years focused in Regulatory Affairs + Include the qualifications preferred… more
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