- 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
- Merck & Co. (North Wales, PA)
- …individual will have excellent communication and collaboration skills and will work closely with a global regulatory lead (s) to help develop and implement a ... Job DescriptionThe Associate Director , Regulatory Affairs, supports products in...and attending Agency meetings as needed to assist the global regulatory lead .Participating as an… 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
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Executive Director and Global Lead , Patient Advocacy & Strategic Alliances position resides in the Value & Implementation (V&I) ... Global Clinical Trial Operations (GCTO) and Data Project Lead (DLP) teams to ensure and assist awareness and...experience in global patient advocacy and engagement activitiesUS/ global experience in regulatory affairs, medical and… 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
- 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
- Merck & Co. (Durham, NC)
- Job DescriptionWe're looking for a Director of Quality Assurance to lead quality across the full value chain for a late-stage ophthalmic program. In this role, ... excellence from development through commercialization. You'll partner across Quality, Regulatory , Technical, and Supply Chain teams-coaching, facilitating, and removing… 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)
- …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
- 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
- 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
- Insmed Incorporated (NJ)
- …diseases. Reporting to the Head of Scientific Communications & Publications, you'll lead the development and implementation of global Medical Communications ... Communications plan for the assigned therapeutic area(s) and product(s) (pulmonology/infectious disease). Lead the creation and execution of the global medical… more
- Insmed Incorporated (San Diego, CA)
- …patient counts - and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare ... the future of science, we're in. Are you?About the Role:We're looking for a Director , Clinical Scientist for the Gene Therapy Clinical Development team to help us… more
- Merck & Co. (North Wales, PA)
- Job DescriptionRole SummaryThe Director Scientific Patient Engagement Lead is responsible for developing and implementing a global headquarters strategic ... the work of our company.- The Scientific Patient Engagement Lead manages and enables the planning and execution of...as well as knowledge of best practices in those areasU.S./ Global experience in clinical research, regulatory affairs,… more
- Merck & Co. (Millsboro, DE)
- …Expert (SME) - Associate Director , will report to the Animal Health Global Quality Compliance and Technical Lead .-- The responsibility of this position is ... Compliance (IC), and Policy, Licensing and Evaluation (PEL).Develop and maintain global Quality Management System (QMS) documents pertaining to USDA requirements for… more
- Insmed Incorporated (NJ)
- …patient counts - and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare ... accountable for creating a best-in-class team to plan, integrate and lead activities associated with moving Insmed's late-stage pipeline through clinical… more
- Repligen (Waltham, MA)
- OverviewMake a global impact-join Repligen.We're united by a mission to inspire advances in bioprocessing as a preferred partner in the production of biologic drugs ... Supply Chain, Product Development, and R&D organizations. As a Director of IT, you will play a key role...solutions comply with GMP (Good Manufacturing Processes) and other regulatory requirements.Partner with process owners to optimize SAP and… more
- Merck & Co. (Millsboro, DE)
- …transfer leadsStrong understanding of cGMP, PPQ, validation (process/cleaning/CSV), and global regulatory frameworks (USDA)Excellent verbal and written ... our Global Science & Technology Network leadership team to lead complex, site-to-site technology transfers for Animal Health vaccines across our US… more
- Lundbeck (North Hyde, SD)
- …role has a global collaborative outreach and the Compliance and Legal Director will be part of Lundbeck's Regional Compliance Officer network and have a dotted ... is currenting recruiting for a qualified Compliance and Legal Director to join our team. The role reports to...Australia and New Zealand in and contribute to the Global Legal, Compliance & Sustainability organisation by providing periodic… more
