- Daiichi Sankyo, Inc. (Bernards, NJ)
- …company's growth, thereby accomplishing corporate goals.Responsibilities:Develop and implement US regulatory strategy for assigned project(s). Strategize and ... with FDA. This role will create and implement effective regulatory strategies to deliver on efficient and robust development...will direct, coordinate and implement the preparation of US regulatory submissions and provide US regulatory support… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionWe are seeking a Director (Principal Scientist), Global Regulatory Affairs Liaison with a visionary, growth-oriented mindset that can help ... advance our pipeline and drive our strategic priorities.The Director , Principal Scientist - Regulatory Affairs...Liaison is responsible for development and implementation of worldwide regulatory strategy for their assigned projects in… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …be responsible for bringing the issue and potential solutions to the Head of US Regulatory Affairs in conjunction with the assigned US RA strategist on the ... transparent ways of working across the Alliance within US regulatory affairs and will work closely with...alliance assets for operational matters. Responsibilities:Develop and implement US regulatory strategy for assigned project. Lead and… more
- Merck & Co. (Rahway, NJ)
- …with key stakeholders, including research and development, manufacturing, quality assurance, regulatory affairs , and external partners, to ensure alignment and ... Job DescriptionThe Executive Director , Device Technical Operations is a pivotal leadership...communicate a clear vision and ensure execution of the strategy for the technical transfer of medical devices and… more
- Merck & Co. (Rahway, NJ)
- …our Company, collaborating with project teams, biomarker leads, clinical operations, and regulatory affairs on the implementation of global CDx assay strategies ... Job DescriptionIn this Principal Scientist/ Director position within Translational Oncology, this team member will provide leadership for aligned and integrated… more
- Merck & Co. (Rahway, NJ)
- …staff, Pharmaceutical Development colleagues, Quality Assurance, Technical Operations, and CMC Regulatory Affairs as needed to ensure understanding of needs, ... Job DescriptionThe Executive Director for Cell Based Sciences within Analytical R&D...scientists in the organization in the definition of potency strategy and development, validation, implementation, and technology transfer of… more
- Merck & Co. (Rahway, NJ)
- …ethics-committees, and internal auditors in conjunction with CCQM, compliance, Regulatory ,-Pharmacovigilance (PV) and Medical Affairs .Responsible and supports ... Job DescriptionThe Clinical Research Director (CRD) is the Clinical Operations lead in...regional and global colleagues develops and executes the GCTO strategy for the-country/cluster - such as Industry associations.Leadership and… more
- Formation Bio (New York, NY)
- …preventive actions (CAPA as needed. Collaborate with cross-functional teams (eg, CMC, Regulatory Affairs , Clinical Operations) to ensure alignment on quality ... to patients faster and more efficiently.About the PositionThe Sr. Director , GMP Quality Assurance will lead the GMP QA..., GMP Quality Assurance will lead the GMP QA strategy and execution for Formation Bio's portfolio. Acting as… more
- Merck & Co. (Rahway, NJ)
- …of interest.Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, medical affairs and manufacturing to ... will manage the entire cycle of clinical development, including development strategy , study design, initiation, execution, monitoring, analysis, regulatory … 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 regulatory leadership on the project teams in this area. We are a hands-on culture so responsibilities will include… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …thereby accomplishing corporate goals. **Responsibilities:** + Develop and implement US regulatory strategy for assigned project(s). Strategize and plan for ... Years in the pharmaceutical industry required. + 8 or More Years in regulatory affairs + Experience in providing regulatory strategic input into the drug… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …+ 7 or More Years in the pharmaceutical industry + 4 or More Years in regulatory affairs , NDA, sNDA, BLA filing to FDA **Travel** Ability to travel up to ... and partner with FDA; direct, coordinate and implement the preparation of all regulatory submissions and provide regulatory support across all global projects,… more
- J&J Family of Companies (Raritan, NJ)
- …step of the way. Learn more at https://www.jnj.com/innovative-medicine We are seeking a Director , Global Medical Affairs Strategy & Execution in Oncology. ... Primary Responsibilities include, but are not limited to: The Director , Global Medical Affairs Strategy & Execution collaborates with the Global Medical … more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …be responsible for bringing the issue and potential solutions to the Head of US Regulatory Affairs in conjunction with the assigned US RA strategist on the ... transparent ways of working across the Alliance within US regulatory affairs and will work closely with...for operational matters. **Responsibilities:** + Develop and implement US regulatory strategy for assigned project. Lead and… more
- AbbVie (Branchburg, NJ)
- …YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Associate Director , Regulatory Affairs US Advertising and Promotion is ... responsible for setting strategy and leading cross-functional, multidisciplinary, therapeutic teams, and executes...industry experience. Certification a plus + Experience in US Regulatory Affairs Advertising and Promotion preferred +… more
- Sanofi Group (Morristown, NJ)
- **Job title** : Director , US Regulatory Affairs - Advertising and Promotion **Location:** Cambridge, MA or Morristown, NJ **About the Job** Are you ready to ... you will be considered the resident expert in Global Regulatory Affairs Region NA, Advertising & Promotion...and direct reports. + In conjunction with the Sr. Director /Product Support Head, imparts senior regulatory guidance… more
- BlackRock (New York, NY)
- …retirement, energy security, financial technology, and critical infrastructure. This role is for a Director of Regulatory Affairs on the US Government ... policymakers around the world on financial markets policy. Since 2009, the Government Affairs & Public Policy team has steadily established the firm as a respected… more
- Merck (Rahway, NJ)
- …Development Execution, The primary function includes coordinating various GRACS (Global Regulatory Affairs and Clinical Safety) functional areas, to ensure ... and Inclusion principles. **Desired Experience:** + Experience with Alliance Management and/or Regulatory strategy and process for partnerships (multiple deal or… more
- City of New York (New York, NY)
- … Director of OCMH and executive staff to set and execute the External Affairs strategy for the office. Additionally, the Deputy Executive Director will ... Community Mental Health (OCMH) is seeking a Deputy Executive Director , External Affairs who will head the...by directing and supporting the development of OCMH's media strategy to ensure clear and compelling updates to the… more
- Mallinckrodt Pharmaceuticals (Bridgewater, NJ)
- Job Title Director , Clinical Development and Medical Affairs (nitric oxide) Requisition JR000014860 Director , Clinical Development and Medical Affairs ... (Open) Location Bridgewater, NJ Additional Locations Job Description Summary Job Description The Director of Clinical Development and Medical Affairs plays a key… more
