- Mitsubishi Chemical Group (Jersey City, NJ)
- …on real-world evidence, and creating hope for all facing illness. The Director, Regulatory Affairs provides strategic global regulatory guidance to ... requests, meeting requests, and briefing documents. + Acts as liaison between Regulatory Affairs and other functional areas, including external contractors (eg,… more
- 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
- Ascendis Pharma (Princeton, NJ)
- …to working together as one team to achieve extraordinary results. The Sr. Manager Regulatory Affairs , Advertising and Promotion will be an internal expert on US ... of prescription drug and biologic products. The Sr. Manager Regulatory Affairs , Advertising and Promotion is responsible...and/or disease education communications + Serve as the company's regulatory liaison to the FDA 's Advertising and… 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
- 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
- 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
- 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
- J&J Family of Companies (Titusville, NJ)
- …public forums and with scientists and the media, + In conjunction with the VP Regulatory Affairs , represent the company on an ad-hoc basis at the highest level ... at the FDA and other regulatory agencies, + Expand...principles + Ability to represent the company in a clinical capacity at appropriate FDA meeting 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
- Mitsubishi Chemical Group (Jersey City, NJ)
- … Operations, Chemistry, Manufacturing and Controls (CMC), Product Quality Assurance (PQA), Regulatory Affairs and Sourcing departments. + Identifies suitable ... (edaravone) oral suspension in 2022. The company handles research, clinical development, sales, marketing, medical affairs , and...any current or potential new CPOs. + Collaborates with Regulatory Affairs to provide all documents required… more
- Hackensack Meridian Health (Neptune, NJ)
- …executed. + Works on special projects for Research department quality assurance, regulatory affairs and education sections, including review and submission of ... + Bachelor's degree in Nursing + Minimum of 6 or more years of experience in clinical research experience. + Working knowledge of FDA and DHHS regulations, Good … more
- Merck (Rahway, NJ)
- …such as , Clinical Research Associates, Statisticians, Quality Assurance, and Regulatory Affairs to drive data excellence and enhance the efficiency of ... clinical research and clinical trial methodologies. + Strong regulatory knowledge, including FDA /CVM, EMA/CVMP, and VICH guidelines. + Excellent… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- … trials, across all therapeutic areas, around the world. In partnership with Clinical Research, Medical Affairs and Development functions, ensures that all ... aspirations. Join Gilead and help create possible, together. **Job Description** ** CLINICAL OPERATIONS:** Clinical Operations is responsible for the execution… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …trials, across all therapeutic areas, around the world. In partnership with Clinical Research, Medical Affairs and Development Operations functions, ensures that ... aspirations. Join Gilead and help create possible, together. **Job Description** ** CLINICAL OPERATIONS:** Clinical Operations is responsible for the execution… 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