- 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
- Novo Nordisk Inc. (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
- Genmab (Plainsboro, NJ)
- …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...new indications. You will act as contact person with FDA and provide regulatory expertise and guidance… more
- Novo Nordisk Inc. (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
- Genmab (Plainsboro, NJ)
- … Affairs (Oncology experience preferred) Direct interaction/negotiation skills with regulatory authorities (eg FDA , EMA) A broad knowledge of life-cycle ... passionate leader to be a part of our Global Regulatory Affairs (GRA) organization.In this role, the...regulatory requirements for programs and products. Participate in regulatory sub-team, clinical management team, and labeling… more
- Merck & Co. (Rahway, NJ)
- …such as , Clinical Research Associates, Statisticians, Quality Assurance, and Regulatory Affairs to drive data excellence and enhance the efficiency of ... of clinical research and clinical trial methodologies.Strong regulatory knowledge, including FDA /CVM, EMA/CVMP, and VICH guidelines.Excellent strategic… more
- Novo Nordisk Inc. (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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …around rare diseases and immune disorders. SummaryThis position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global Product Team ... on new product labeling in collaboration with the Global Regulatory Leads (GRLs) and Clinical Safety &...for cross-functional teams on RA labeling issues. Collaborate with Regulatory Affairs and Labeling colleagues in other… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …relationships with key stakeholders within CSPV and external functions including Clinical Development, Research Development, Regulatory Affairs . Facilitate ... trends, legislative changes, and guidelines issued by global regulatory agencies ( FDA , EMA, MHRA, etc.) related...Event and drug coding conventions (MedDRA, WHO-DD)- Knowledge of FDA and global PV regulations, clinical and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …rare diseases and immune disorders. Summary This position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global Product Team ... on new product labeling in collaboration with the Global Regulatory Leads (GRLs) and Clinical Safety &...for cross-functional teams on RA labeling issues. Collaborate with Regulatory Affairs and Labeling colleagues in other… more
- Tris Pharma (Monmouth Junction, NJ)
- …working knowledge of regulatory and industry standards related to Medical Affairs role including Food and Drug Administration ( FDA ), Office of Inspector ... for scientific exchange with prioritized stakeholders in support of Medical Affairs strategiesCoordinates MSL support for clinical activities and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Strategy and Evidence (CDSE) but more broadly within Clinical , Medical and Regulatory (CMR), Market Access and Public Affairs (MAPA), as well as ... 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
- Novo Nordisk Inc. (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
- 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
- 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
- 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
- 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
- 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
