- Insmed Incorporated (NJ)
- …each other, and for the future of science, we're in. Are you?About the Role:The Global Regulatory Lead (GRL) will be responsible for formulating and ... product development and submission activities. The GRL will serve as the global regulatory lead for documentation review prepared by other technical… more
- Eisai, Inc (Nutley, NJ)
- …make a difference. If this is your profile, we want to hear from you. The Director , Global Regulatory , Growth Markets will be responsible for providing ... management of staff.Determining timelines and budgets for program activities and report accordingly. Lead and participate in global regulatory initiatives and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …deemed necessary. Ensure inspection readiness are adequately performed and may support and/or lead regulatory inspection activities at DS facilities and / or ... diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi...collaboration with other QA functions and/or applicable stakeholders. Support/ lead and or co lead due- diligence… more
- Merck & Co. (Rahway, NJ)
- …- Functional Area: Regulatory Innovation and Information Management (RIIM) within Global Regulatory Affairs & Clinical Safety (GRACS) - The Associate ... Job Description Associate Director , Regulatory Submissions Archive Operations -...user requirements, workflows, and metadata standards. Ensure compliance with global regulatory standards and internal SOPs for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the Sr. Director , representing the Quality organization at senior levels. The Director plays a pivotal role in regulatory inspections, external audits, and ... Director , Medical Affairs QA as needed. Cross-functional and Global Team Participation:Drive quality excellence through effective business partnerships with… more
- Insmed Incorporated (NJ)
- …company and regulatory policies and procedures. In addition, the Senior Director will be responsible, globally, for implementing the safety and risk management ... from regulatory authorities on safety issues for assigned products and lead the integrated safety input into all regulatory documents where required.Maintain… more
- Insmed Incorporated (NJ)
- …(MRC) Operations is responsible for managing the operational execution of the company's Global We're looking for an Associate Director , Medical Review Committee ... so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of...for patients with serious diseases. Reporting to the Senior Director , Medical Review Committee (MRC), you'll be responsible for… more
- Formation Bio (New York, NY)
- …and marketing Formation Bio's assets. This role includes the lead regulatory responsibility for support of global registration and life cycle support ... treatments to patients faster and more efficiently.About the PositionThe Senior Director , Regulatory Affairs lead is responsible for developing and directing… more
- Genmab (NJ)
- …like a fit? Then we would love to have you join us!Overview:The Director , Feasibility Lead , will drive the implementation of strategic, data-driven feasibility ... internal processes, mentoring team members, and contributing to cross-functional strategies.The Director will lead complex feasibility initiatives and serve as… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionSr. Principal Scientist - Device Technical and Engineering Lead (Sr. Director Equivalent)Our company's Device Product & Process Development (DPPD) ... regulatory , quality, company, and customer requirements.-This position will lead cross-functional development teams within and external to Device Development &… more
- Insmed Incorporated (NJ)
- …global policies and procedures. Ensure compliance with all Company/ Regulatory requirements & TMF quality standards.Work with outsourcing/procurement management to ... so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of...can be hybrid or remote.What You'll Do: Primary operational lead over an 1-2 indications within one compound, in… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. Summary: The Senior Director , Clinical Safety, will lead the development and implementation of ... Global Product Team in collaboration with Clinical Development, Regulatory , Project Management, Biostatistics, Pharmacology, and other departments to… more
- Insmed Incorporated (NJ)
- …what's possible for patients with serious diseases. Reporting to the Senior Director , Global Data Enablement, Corporate & Commercial Reporting, you'll serve ... so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of...in. Are you?About the Role:We're looking for an Associate Director , IT Marketing Technologies, on the Information Technology team… more
- Insmed Incorporated (NJ)
- …understanding of US, EU, and Japanese regulations for human drugs/biologics.Knowledge of global regulatory guidance documents and regulations with emphasis on ... of science, we're in. Are you?About the Role:The Associate Director , Regulatory Affairs, CMC will be responsible... strategies for post-approval changes. This role will also lead CMC regulatory strategy development and implementation… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …At Novo Nordisk, you will have the opportunity to build a career in a global business environment. We encourage our employees to make the most of their talent, and ... Kaiser, institutions, GPOs) and other area/regional accounts. Acts as PCOR Account Lead responsible for leading company response from Deal to Contract (includes… more
- Genmab (NJ)
- …is currently seeking a Director , HEOL (Health Evidence and Outcomes Liaison) Team Lead to be a part of an exciting, passionate, high profile, high impact Medical ... diseases. We strive to create, champion and maintain a global workplace where individuals' unique contributions are valued and...and work in a highly dynamic and collaborative setting.The Director , HEOL Team Lead is part of… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …us? The Position The Director , Key Opinion Leader Strategy & Engagement will lead a team and critically shape KOL strategy & engagement across NN USO. They will ... teams, including sales, medical affairs, market access and policy/advocacy (MAPA), Global Commercial, regulatory affairs, other relevant NNI departments.… more
- Eisai, Inc (Nutley, NJ)
- …along with a proven track record in inspection-facing roles and global regulatory compliance.Essential Functions Clinical Outsourcing Designs and executes ... Director of Clinical Outsourcing provides strategic leadership for global outsourcing and vendor management activities within clinical development. This role… more
- Insmed Incorporated (NJ)
- …you'll have a critical role in hands-on execution and oversight of global regulatory submission activities across assigned programs and market. Under ... operational execution, while supporting cross-functional teams to ensure alignment with global regulatory requirements and internal standards.What You'll Do:… more
- Insmed Incorporated (NJ)
- …diseases. Reporting to the VP, Clinical Development - Gene Therapy, the Executive Director will have responsibility to lead clinical programs across different ... so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of...Are you?About the Role:We're looking for an Executive Medical Director of Ophthalmology, Clinical Development to help us expand… more
