- 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
- 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
- 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
- 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
- Eclaro (Raritan, NJ)
- …Overview: We are seeking a highly motivated and detail-oriented US Medical Scientist Associate to join our medical affairs - targeted therapies team. The ... Scientist Associate Job Number: 24-03333 Be part of a...for scientific/medical validity Support execution of the US Medical Affairs plans in coordination with the Global Medical … 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
- 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
- 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
- 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
- LSI Solutions (Victor, NY)
- …with state-of-the-art devices. After all, our ultimate customer is the patient. POSITION TITLE: Regulatory Associate - Days 8am to 5pm SALARY RANGE: $85,000 - ... $95,000 JOB SUMMARY: The Regulatory Associate applies her/his experience, knowledge, organization skills, and communication skills in a wide variety of tasks.… 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
- Daiichi Sankyo Inc. (Basking Ridge, 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
- Taiho Oncology (Princeton, NJ)
- Associate Director, Regulatory Affairs Strategy Princeton, NJ, USA Req #415 Wednesday, November 27, 2024 Looking for a chance to make a meaningful difference ... filing in US and Europe. Position Summary: + Under the direction of regulatory affairs management, the incumbent independently prepares and directs global … more
- Ascendis Pharma (Princeton, NJ)
- …and committed to working together as one team to achieve extraordinary results. The Associate Director Regulatory Affairs , Advertising and Promotion will be ... governing the promotion of prescription drug and biologic products. The Associate Director Regulatory Affairs , Advertising and Promotion is responsible for… more
- AbbVie (North Chicago, IL)
- …@abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Associate Director Regulatory Affairs , Chemistry, Manufacturing and ... marketing applications and supplements/variations. Builds and maintains relationships within the Regulatory Affairs functional areas, Operations, and Research &… more
- 3M (Monroe, NC)
- Job Description: Job Title Certification and Conformance Regulatory Affairs Associate Collaborate with Innovative 3Mers Around the World Choosing where to ... career. The Impact You'll Make in this Role As a Certification and Conformance Regulatory Affairs Associate you will have the opportunity to tap into your… more
- Abbott (Alameda, CA)
- …work for diversity, working mothers, female executives, and scientists. **The Opportunity** This ** Associate Director Regulatory Affairs - APAC** will work ... location in the Diabetes Division. As a manager, the function of an Associate Director Regulatory Affairs , APAC (Asia Pacific) is to combine knowledge of… more
- Lilly (Indianapolis, IN)
- …in drug development. The purpose of the Associate Vice President - Global Regulatory Affairs , Global Regulatory Policy & Strategy (Genetic Medicine and ... leadership behaviors and regulatory excellence attributes as described in Global Regulatory Affairs white papers + Engage in forums that share regulatory … more