- Formation Bio (New York, NY)
- …new treatments to patients faster and more efficiently.About the PositionThe Senior Director , Regulatory Affairs lead is responsible for developing and directing ... the regional regulatory strategy, objectives, policies, and programs pertaining to developing...marketing Formation Bio's assets. This role includes the lead regulatory responsibility for support of global registration and life… more
- Eisai, Inc (Nutley, NJ)
- …a difference. If this is your profile, we want to hear from you. The Director , Global Regulatory , Growth Markets will be responsible for providing regulatory ... growth markets such as Latin America, the Middle East, and Africa.The Director will manage regulatory submissions, registrations, and lifecycle management… more
- Larimar Therapeutics (Philadelphia, PA)
- …the day - we welcome you! Position Summary: Larimar is seeking a CMC Regulatory Affairs Director to provide professional experience and leadership supporting the ... products in development through global marketing authorization approval and launch. The Regulatory Affairs Director will be a key member of project teams and the… more
- Unknown (Boston, MA)
- …expertise and guidance to the client contact for CMC development teams. The Director will also lead regulatory intelligence activities, monitoring changes in ... The Director will collaborate cross-functionally with internal teams to...cross-functionally with internal teams to ensure alignment of CMC regulatory strategies with overall development plans and corporate objectives.… more
- Insmed Incorporated (NJ)
- …for the future of science, we're in. Are you?About the Role:The Global Regulatory Lead (GRL) will be responsible for formulating and implementing global ... regulatory strategies and plans to enable efficient, competitive product...product development for assigned programs. This role will provide regulatory input to global cross-functional project teams throughout product… more
- Insmed Incorporated (NJ)
- …what's possible for patients with serious diseases. Reporting to the Associate Director , Regulatory Affairs, Tactical Implementation, you'll have a critical role ... of science, we're in. Are you?About the Role:We're looking for a Manager, Regulatory Affairs, Tactical Implementation, on the Regulatory Affairs team to help… more
- Insmed Incorporated (NJ)
- …what's possible for patients with serious diseases. Reporting to the Executive Director , Regulatory Operations, you'll be responsible for the publishing, ... in. Are you?About the Role:We're looking for an Associate, Regulatory Operations on the Regulatory team to...management, and submission of regulatory documents in accordance with global health authority requirements.… more
- Eisai, Inc (Chicago, IL)
- …vendor management, and technical oversight to support the objectives of Global Regulatory Operations. The Associate Director will collaborate with the Heads ... this is your profile, we want to hear from you. The Associate Director of Global Submission Management (GSM) is responsible for leading, managing, strategizing, and… more
- Eisai, Inc (Nutley, NJ)
- …that optimize cost, enhance vendor performance, and mitigate operational and regulatory risks. The Senior Director oversees vendor qualification, governance ... this is your profile, we want to hear from you. The Senior Director of Clinical Outsourcing provides strategic leadership for global outsourcing and vendor… more
- Eckert & Ziegler Isotope Products, Inc. (Valencia, CA)
- …& Regulatory Manager to join our team. The Quality Assurance and Regulatory Manager supports the Director of Quality Operations in maintaining an effective ... Quality Assurance & Regulatory Manager Valencia & Burbank, CA Company Benefits...that appropriate current procedures are followed and keeps the Director of Quality Operations and other designates fully informed,… more
- Harbor Health Services, Inc. (Mattapan, MA)
- …to medical review decisions and authorization issues from EOHHS, CMS and other regulatory entities. Collaborates with Senior Medical Director to resolve complex ... and cares for more than 580 participants. We are currently seeking a Director of Utilization Management & Quality Programs. Harbor Health offers an excellent,… more
- Merck & Co. (North Wales, PA)
- …adherence, and outcomes while maintaining compliance with the highest ethical and regulatory standards.- The Director will collaborate closely with the US ... Job Description Director Global Marketing Immunology - IBD Patient Strategy...acumen.Agility in navigating diverse healthcare landscapes, cultural nuances, and regulatory frameworks.Proven ability to inspire, influence, and build alignment… more
- Novo Nordisk Inc. (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 healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Merck & Co. (Upper Gwynedd, PA)
- …science that radically changes the way we approach serious diseases. --The Senior Director will report to an Associate Vice President in the Oncology Clinical ... Research Group. Under the guidance of a supervisor, the Senior Director has primary responsibility for the planning and directing of clinical research activities… 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 ... we're in. Are you?About the Role:We are seeking a highly experienced Senior Director , DSPV Medical Safety to help us expand what's possible for patients with… more
- Merck & Co. (Rahway, NJ)
- …development strategy, study design, initiation, execution, monitoring, analysis, regulatory reporting, and publication.Specifically, the Senior Director ... Job DescriptionThe Senior Director (Sr. Principal Scientist) has primary responsibility for...closely with a cross-functional group of experts in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development… more
- Eisai, Inc (Durham, NC)
- …difference. If this is your profile, we want to hear from you. The Director , Global Labeling is responsible for the leadership and oversight of the Labeling function ... within Global Regulatory Services and Operations (GRSO). This position will manage...Salary Transparency Language:The annual base salary range for the Director , Global Labeling is from :$180,700-$237,200Under current guidelines, this… more
- Insmed Incorporated (NJ)
- …and for the future of science, we're in. Are you?About the Role:The Director , EHS (Environmental, Health, and Safety) isa senior-level role responsible for creating ... and implementing programs that ensure workplace safety, regulatory compliance, and environmental protection for all Insmed locations.Key duties include risk… more
- Eisai, Inc (NJ)
- …difference. If this is your profile, we want to hear from you. The Director of Clinical Outsourcing is responsible for leading the development and execution of ... deliver cost efficiencies, enhance vendor performance, and ensure compliance with regulatory and corporate standards. This role manages CRO and vendor relationships,… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionReporting into the Executive Director Packaging Technical Operations the Director Packaging Distribution, Components and Systems Center of ... compliant supply of commercialized products for the benefit of patients. The Director of Packaging Distribution, Components and Systems COE is integral to this… more
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