- Novo Nordisk Inc. (Plainsboro, NJ)
- …ready to make a difference? The Position We are seeking a dynamic and experienced Regulatory Affairs Labeling Associate Manager to oversee and lead critical ... find better and more innovative ways to improve their quality of life. We're changing lives for a living....The ideal candidate will collaborate with cross-functional teams of Regulatory Affairs Therapeutic Area (TA) Managers, Global… more
- Genmab (Plainsboro, NJ)
- …and authentic is essential to fulfilling our purpose.The RoleGenmab is looking for an Associate Director, Global Regulatory Affairs , Regulatory Strategy ... to be a part of our Global Regulatory Affairs organization.In this role, you will...be responsible for planning, coordinating, and executing timely and high- quality submissions to the FDA.This is a hybrid position… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …lives for a living. Are you ready to make a difference? The Position The Associate Director, Regulatory Affairs - Advertising & Promotion will provide ... Relationships Develop and maintain positive rapport and working relationships with Regulatory Affairs , Legal, Commercial, and other cross-functional stakeholders… more
- Merck & Co. (Rahway, NJ)
- …close collaboration with numerous stakeholders such as , Clinical Research Associates, Statisticians, Quality Assurance, and Regulatory Affairs to drive data ... of stakeholders, including medical researchers, veterinarians, project managers, and regulatory affairs professionals, to achieve project goals.Key… 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
- 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
- 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
- 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
- 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
- IQVIA (Parsippany, NJ)
- …regulatory document types; * May plan and deliver workshops or presentations on Regulatory Affairs topics for conferences or publications; * May be assigned ... Job Overview Direct, oversee and manage complex regulatory projects, ensuring quality deliverables on time and within budget. Ensure that all project work is… 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)
- …affordable, and equitable patient care. Ensures compliance with accreditation and regulatory standards. Fosters a safe and supportive environment conducive to the ... Supports colleagues and other nurses through knowledge sharing to provide safe, quality nursing care. Equips staff with tools for culturally competent care and… more
- Veterans Affairs, Veterans Health Administration (New York, NY)
- …to persuade and influence clinical and management decisions. b. Expert understanding of regulatory and quality standards for their program area. c. Ability to ... integrated with other services' function. The incumbent performs process improvement, quality assurance and administrative functions as requested that are inclusive… more
- Takeda Pharmaceuticals (Trenton, NJ)
- …+ 8+ years of experience in the pharmaceutical industry, with 6+ years in Regulatory Affairs , quality assurance/compliance, or research and development. + ... to improve processes and infrastructure in line with global regulatory expectations and Global Regulatory Affairs... Affairs (GRA) technology roadmap. + Promotes regulatory information quality , reporting, and development and… more
- Bristol Myers Squibb (New Brunswick, NJ)
- …and connect with PV, Medical Affairs and Regulatory Affairs + Contribute to develop Quality Management Systems training elements **Qualifications ... + Minimum 10 years QA experience or relevant experience in medical quality management, biomedical science, clinical development, or regulatory compliance… more
- CUNY (Brooklyn, NY)
- …scholarly research. Reporting to the Provost and Senior Vice President for Academic Affairs at Medgar Evers College, the Associate Provost for Assessment, ... Associate Provost for Assessment, Accreditation & Institutional Effectiveness...the College's mission is to develop and maintain high quality , professional, career-oriented undergraduate degree programs in the context… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …on real-world evidence, and creating hope for all facing illness. The Associate Director, Quality Management System will be responsible for supporting ... 2022. The company handles research, clinical development, sales, marketing, medical affairs , supply chain,and business development functions. MTPA is dedicated to… more
- City of New York (New York, NY)
- …researcher, a clear and concise writer, a creative thinker, and a team player. The Associate 's work product must be of high quality , timely and well organized, ... Only candidates under consideration will be contacted. The Legal Associate (" Associate ") will report directly to, and...General Counsel and become an expert in the City's regulatory process and other legal issues that impact the… more
- J&J Family of Companies (Raritan, NJ)
- …of Bachelor's degree or equivalent experience in a related field (Pharmacy, Life Sciences, Regulatory Affairs , etc.) + A minimum of 8 years of experience in ... Johnson & Johnson Innovative Medicine is recruiting for Associate Director, RA Submissions. The position can be... regulatory affairs , submission management, or a related… more
