- Amneal Pharmaceuticals (Piscataway, NJ)
- …The Associate II (A), assists with minimal guidance, the Senior Director of Regulatory Affairs Clinical / FDA Communications.Assists the Senior ... communications/ updates Essential Functions: + Assist the Senior Director of Clinical Regulatory Affairs / FDA Communications in managing, coordinating,… more
- Cardinal Health (Trenton, NJ)
- **_What Regulatory Affairs and Clinical ...+ Strong knowledge of global regulatory requirements ( FDA , EMA, ICH, etc.) and clinical trial ... contributes to Cardinal Health_** The _Manager, Regulatory Affairs ( Clinical Submissions)_ is responsible for ensuring...including INDs, NDAs, BLAs, CTAs, and other filings to regulatory authorities ( FDA , EMA, etc.). + Manage… more
- Ascendis Pharma (Princeton, NJ)
- …working together as one team to achieve extraordinary results. The Associate Director Regulatory Affairs , Advertising and Promotion will be an internal expert on ... the promotion of prescription drug and biologic products. The Associate Director Regulatory Affairs , Advertising and Promotion is responsible for providing… more
- Sumitomo Pharma (Trenton, NJ)
- …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... templates + Solid understanding of medical terminology, and FDA and ICH regulations/guidances specific to clinical … 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 in ... incumbent will be assigned to lead/support one or two clinical development programs as Regulatory Lead (RL),...and Europe. Position Summary: + Under the direction of regulatory affairs management, the incumbent independently prepares… more
- Novo Nordisk (Plainsboro, NJ)
- …This individual works cross-functionally with internal and external departments on Regulatory Affairs labeling related issues. Relationships Reports to labeling ... About the Department The Clinical , Medical and Regulatory (CMR) department...and working relationships with company stakeholders. Effective collaboration with Regulatory Affairs , CMR, Supply Chain, and HQ… more
- Sumitomo Pharma (Trenton, NJ)
- …seeking a dynamic, highly motivated, and experienced individual for the position of **Director Regulatory Affairs ** . The Director is part of the Global ... Regulatory Affairs (GRA) team based in the...Regulatory Affairs (GRA) team based in the US. He/she will... templates + Advanced understanding of medical terminology, and FDA and ICH regulations/guidances specific to clinical … more
- Sumitomo Pharma (Trenton, NJ)
- …the Medical Affairs department on the RETHYMIC lifecycle team to provide medical affairs input to Clinical Research and Clinical Operation's needs. + ... conduct of clinical studies. + 8+ years of relevant Medical Affairs work experience in biotech or pharmaceutical industry, or equivalent professional clinical… 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
- Mount Sinai Health System (New York, NY)
- … Regulatory Coordinator will be responsible for supporting the regulatory affairs team to ensure compliance with FDA regulations, ICH-GCP guidelines, and ... regulatory ); MS degree or advanced certification in regulatory affairs or clinical research...Proficient with MS Word and Excel + Experience with FDA , EMA or other global health authority submissions is… more
- J&J Family of Companies (Raritan, NJ)
- …of local labels as appropriate. + Provides regulatory input to clinical development programs, risk/benefit assessments, and medical affairs programs. + ... strategies are in alignment with product portfolio, regional strategies, CMC- Regulatory Affairs strategy, commercial and market access...+ Serve as primary point of contact for US FDA + Lead the regulatory response team… more
- United Therapeutics (Trenton, NJ)
- …primarily responsible for providing expert legal support to Marketing, Sales, Medical Affairs , Patient Relations, Regulatory Affairs and Corporate ... Company's various products. + Provide guidance to Sales, Marketing, Medical Affairs , Patient Relations, Regulatory and Corporate Compliance departments related… 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 ... Assurance, Pharmaceutical Manufacturing, or Compliance + Knowledge of US FDA regulatory requirements as it pertains to...a regulated field is required + Deep understanding of FDA and cGMP regulations pertaining to clinical … more
- Novo Nordisk (Plainsboro, NJ)
- …+ Serve on Local Labeling Committee (LLC) and provide medical input to Regulatory Affairs Physical Requirements 20-30% overnight travel required. 30% overnight ... 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
- 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)
- …Internal stakeholders: Global Safety, QPPV office, Global Development, Product Supply, Regulatory Affairs (NNI/NNCI) marketing, legal and NNI Patient Support ... 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
- Taiho Oncology (Princeton, NJ)
- …preferred. Knowledge, Skills, and Abilities: + 8-10 years Hematology / Oncology Medical Affairs and Clinical experience preferred. + At least 2-5 years' ... and evolving needs of patients. Advanced technology, a world-class clinical development organization, and state-of-the-art facilities: these and other resources… more
- Bristol Myers Squibb (Princeton, NJ)
- …health and optimize product benefit-risk profiles. The VP 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
- Terumo Medical Corporation (Somerset, NJ)
- …work with stakeholder departments such as Engineering, Operations, Clinical , Medical Affairs and Regulatory Affairs on Post Market Surveillance strategy ... products, training and education programs that drive clear economic value, better clinical outcomes and improved quality of life for patients. TMC is part… 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