- 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 ... support across all global projects; meet aggressive deadlines to ensure that regulatory agencies receive timely and quality submissions, shortening the review… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … Affairs , Quantitative Clinical Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory /Risk Management, Quality Assurance, Medical Affairs , ... efficient, adaptable, and scalable architectures in accordance with company policies, regulatory standards, and integration methodology. 15 E- Work with the business… 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 ... find better and more innovative ways to improve their quality of life. We're changing lives for a living....including members of the CDSE team, clinical development, medical affairs , regulatory , and commercial, to facilitate the… 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Board, Patient Marketing, Managed Markets, Trade, Corporate Communications, Legal, Regulatory , Medical Information and Medical Affairs . External relationships ... to ensure requests are completed Detail-oriented with a strong attention to quality results Experience with legal/ regulatory review processes desired Strong… 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
- Englewood Lab, Inc (Totowa, NJ)
- Title: Regulatory Affairs Associate Reports to: Manager of Regulatory Affairs Department: Quality / Regulatory Responsibilities: + Assist the ... of the Head of Quality / Regulatory . + Assist the Manager of Regulatory Affairs during periodic quality reviews, regulatory updates, and annual GMP… more
- Taiho Oncology (Princeton, NJ)
- Associate Director, Regulatory Affairs ...following an agreed upon plan. The incumbent conducts the regulatory activities to ensure high quality , ... filing in US and Europe. Position Summary: + Under the direction of regulatory affairs management, the incumbent independently prepares and directs global … more
- Takeda Pharmaceuticals (Trenton, NJ)
- …application is true to the best of my knowledge. **Job Description** The Regulatory Affairs -Labeling, Associate Director is responsible for ensuring that ... to the world. **How you will contribute:** + The Associate Director, GRA Labeling Compliance, is responsible for the...activities pertaining to global and local labeling compliance and quality within Global Regulatory Affairs .… more
- Sumitomo Pharma (Trenton, NJ)
- …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...members in developing strategy for applicable documents/activities + Ensures quality and content of submissions to Health Authorities +… more
- ManpowerGroup (Rahway, NJ)
- JOB TITLE / VERSION: Associate Principal Scientist, Regulatory Affairs DIVISION- R&D DEPARTMENT: Global Regulatory Affairs - CMC LOCATION: Rahway, NJ ... Associate Principal Scientist is responsible for developing CMC regulatory submission strategies and timelines for assigned pharmaceutical projects/products in… more
- System One (Rahway, NJ)
- Job Title: Associate Principal Scientist, Regulatory Affairs Location: Rahway, NJ (Hybrid) Hours/Schedule: Mon- Fri; 8am- 5pm Type: Contract Responsibilities ... Associate Principal Scientist is responsible for developing CMC regulatory submission strategies and timelines for assigned pharmaceutical projects/products in… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …More Years in the pharmaceutical industry preferred + 1 or More Years in regulatory affairs required + Experience in (s)NDA/BLA filing to FDA preferred ... support across all global projects; meet aggressive deadlines to ensure that regulatory agencies receive timely and quality submissions, shortening the review… more
- Bristol Myers Squibb (Princeton, NJ)
- …years in the industry with at least 4+ years of US Medical Device Regulatory Affairs experience **Key Competencies** + Experience in successfully leading teams; ... careers.bms.com/working-with-us . **Position Responsibilities** + Leadership responsibility for global regulatory strategy to support the development of biomarkers, companion… more
- Organon & Co. (Jersey City, NJ)
- …Organon Regulatory Chemistry, Manufacturing and Controls New Products, the Associate Principal Scientist ( Associate Director) is responsible for ... scientists in the Organon franchise teams. + Lead development and execution of regulatory CMC strategies to ensure high quality , accuracy, and high likelihood… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …pharmaceutical industry experience required + 4 or More Years of direct regulatory affairs experience, including US labeling experience required + Experience ... This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational leadership on product… more
- Veterans Affairs, Veterans Health Administration (Kings County, NY)
- …care. Responsibilities Functions or Scope of Assigned Duties: The Deputy Chief of Quality Management (QM) is a member of the executive administrative team and ... for ongoing oversight of all aspects of the healthcare system to ensure quality and minimize risk, and guides the organization through frequent interactions with… more
- Catalent Pharma Solutions (Somerset, NJ)
- …NJ is hiring a Senior Regulatory and Compliance Specialist for the Regulatory Affairs Group. The Senior Regulatory and Compliance Specialist candidate ... and the greater organization as it touches various functional areas including: Supplier Quality , Regulatory Compliance, DEA, and Quality Management Systems.… more
- VNS Health (Manhattan, NY)
- …as necessary and appropriate. + Collaborates with cross-functional teams, including Operations, Quality , IT, Compliance, Government Affairs , and Risk, to ensure ... compliance and identify risk areas. Serves as the primary liaison to outside regulatory counsel. Works within the Chief Legal and Risk Officer Organization ("CLRO")… more
