- Novo Nordisk (Plainsboro, NJ)
- …to make a difference? The Position We are seeking a dynamic and experienced Regulatory Affairs Labeling Associate Manager to oversee and lead critical tasks ... About the Department The Clinical , Medical and Regulatory (CMR) department...The ideal candidate will collaborate with cross-functional teams of Regulatory Affairs Therapeutic Area (TA) Managers, Global… more
- Novo Nordisk (Plainsboro, NJ)
- …Are you ready to make a difference? The Position The Associate Director, Regulatory Affairs - Advertising & Promotion will provide strategic regulatory ... Relationships Develop and maintain positive rapport and working relationships with Regulatory Affairs , Legal, Commercial, and other cross-functional stakeholders… more
- Merck (Rahway, NJ)
- …Development Teams and regulatory single point-of-contact for products within Global Regulatory Affairs and Clinical Safety (GRACS) and external to ... **Job Description** We are seeking a Director (Principal Scientist), Global Regulatory Affairs Liaison with a visionary, growth-oriented mindset that can help… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- The Director Regulatory Affairs will provide leadership on global regulatory activities for the assigned products. Responsibility will mainly focus on ... Clinical Regulatory filings and provide ...if:** + If you bring strong understanding of US FDA and international pharmaceutical guidance, regulations, drug development process,… 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
- Amneal Pharmaceuticals (Piscataway, NJ)
- …Global Regulatory Strategies: Formulate and lead global CMC and clinical regulatory strategies for Biologics, Biosimilars, and Small Molecules.Ensure ... advice to cross-functional teams and ensure compliance with FDA , EMA, and Health Canada regulations. Assess regulatory... FDA , EMA, and Health Canada regulations. Assess regulatory impact of changes in CMC procedures and oversee… more
- System One (Florham Park, NJ)
- Job Title: Director, US Regulatory Affairs Location: Florham Park, NJ (50% hybrid) Type: contract Overview: Support the Global Therapeutic Area Lead (GTAL), ... Regulatory Affairs (Senior Director) in developing and...a cross-functional team environment. + Strong knowledge of regional regulatory requirements and guidelines, including FDA regulations… more
- L'Oreal USA (Clark, NJ)
- …from all global R&I hubs in Advanced Research and other partners across clinical functions, regulatory , development labs, brand partners to ensure scientific ... programs to internal and external stakeholders on relevant projects and innovations. + Clinical Trial Support: Provide medical affairs support for clinical … more
- Gilead Sciences, Inc. (New Brunswick, NJ)
- …to requests for information, consistent with promotional compliance, PhRMA guidelines, and FDA regulatory requirements + Implements defined goals and objectives ... reporting to a Field Director. The MS will disseminate clinical information about Gilead's innovative hematology and oncology products...aligned with the Medical Affairs Plan of Action and other strategic initiatives +… more
- Novo Nordisk (Plainsboro, NJ)
- …in developing, implementing/facilitating, maintaining technical training programs related to GxP, Clinical , Medical and Regulatory affairs , Patient Safety ... About the Department The Clinical , Medical and Regulatory (CMR) department...the organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing… more
- J&J Family of Companies (Raritan, NJ)
- …and profoundly impact health for humanity. Learn more at https://www.jnj.com **Job Function:** Regulatory Affairs Group **Job Sub** **Function:** Regulatory ... industry, consumer industry or health authority regulated industry + At least 3 years of Regulatory Affairs experience required with focus on the NA region and … more
- Sanofi Group (Bridgewater, NJ)
- …of US Regulatory strategies (eg, submissions, product defense, labeling development, FDA enforcement, clinical trial support, FDA contacts). + Provide ... you will be the primary therapeutic area liaison with FDA 's Office of Prescription Drug Promotion (OPDP) for drugs,...started? **Main Responsibilities** + In conjunction with the Global Regulatory Affairs Head of Global Advertising &… more
- J&J Family of Companies (Raritan, NJ)
- …quality monitoring & compliance, clinical supplies unit, TA strategy, regulatory affairs , data management, medical writing, biostatistics, global medical ... clinical team in responding to medical and compound-related issues + Working with Regulatory Affairs and global clinical operations with regard to… more
- Novo Nordisk (Plainsboro, NJ)
- …include working with Headquarters, NA CMR including Clinical Trial Management, Medical Affairs , Regulatory Affairs and other NNI skill areas. External ... About the Department The Clinical , Medical and Regulatory (CMR) department...the organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing… more
- Bausch Health (Bridgewater, NJ)
- …Management, CMC, Analytical Sciences, Nonclinical, Clinical Operations, Clinical /Medical Affairs , Biostatistics, and Regulatory Affairs . + Lead the ... Responsible for the technical content and timely completion of clinical pharmacology deliverables as well as regulatory ...dermatology drugs is preferred. + Track record of successful regulatory agency (US FDA ) submissions and interactions… more
- Merck (Rahway, NJ)
- …subject matter expert in flow cytometry, working with project teams, biomarker leaders, clinical operations, regulatory affairs , and physicians to implement ... datasets. + ** Regulatory Knowledge:** Understanding of regulatory guidelines ( FDA , EMA) pertaining to biomarker development and clinical trial processes.… more
- Novo Nordisk (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… more
- Ascendis Pharma (Princeton, NJ)
- …programs, competitive landscape, new therapies, clinical trends, and newly issued regulatory rules and FDA guidance to promptly identify any potential impact ... advocacy groups. + Work with internal stakeholders including Commercial, Legal, Regulatory , Clinical Development, Clinical Operations, Compliance,… more
- Novo Nordisk (Plainsboro, NJ)
- …stakeholders, especially with Medical Directors, Marketing, Marketing Operations, Legal, Regulatory Affairs and externally with agencies. Represent Medical ... About the Department The Clinical , Medical and Regulatory (CMR) department...agencies. Key internal relationships include Marketing Operations, Marketing, Legal, Regulatory Affairs , Medical Affairs , Convention… more
- Bristol Myers Squibb (Princeton, NJ)
- …health and optimize product benefit-risk profiles. The ED works cross-functionally with clinical , regulatory , medical affairs , quality, and commercial teams ... regulatory inquiries. Cross-Functional Leadership and Stakeholder Engagement . Partner with clinical , regulatory , and medical affairs teams to integrate… more