- 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
- Genmab (Plainsboro, NJ)
- …per our hybrid policy.ResponsibilitiesReporting to the Team Lead of Regulatory Strategy , Global Regulatory Affairs , the key responsibilities include but ... an experienced and passionate leader to be a part of our Global Regulatory Affairs (GRA) organization.In this role, the regulatory leader will be primarily… 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
- 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
- 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
- Genmab (Plainsboro, NJ)
- …is essential to fulfilling our purpose.The Role The Associate Director of US Medical Affairs Hematology Strategy will report to the Director , US Medical ... portfolio. The individual will support the development and execution of the US Medical Affairs strategy that is aligned with the company's goals and meets the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …etc.) Project Management: Cross-functional collaboration - Global Research, Global Development, Strategy Access Marketing, Medical Affairs Regulatory Safety, ... across stakeholders (Global Research, Global Development, Market Access, Marketing, Regulatory Affairs , Safety, International Operations, Regions & Affiliates,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …key external partners Cross-functional collaboration - Global Research, Global Development, Strategy Access Marketing, Medical Affairs Regulatory Safety, ... across stakeholders (Global Research, Global Development, Market Access, Marketing, Regulatory Affairs , Safety, International Operations, Regions & Affiliates,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …for a living. Are you ready to make a difference? The Position The Associate Director , Regulatory Affairs - Advertising & Promotion will provide strategic ... Establish strong and positive working relationship with OPDP reviewers. Report to Senior Director , Regulatory Affairs - Advertising & Promotion. Essential… 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …claims Project Management: Cross-functional collaboration - Global Research, Global Development, Strategy Access Marketing, Medical Affairs Regulatory ... across stakeholders (Global Research, Global Development, Market Access, Marketing, Regulatory Affairs , Safety, International Operations, Regions & Affiliates,… 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …stakeholders, especially with Medical Directors, Marketing, Marketing Operations, Legal, Regulatory Affairs and externally with agencies. Represent Medical ... external agencies. Key internal relationships include Marketing Operations, Marketing, Legal, Regulatory Affairs , Medical Affairs , Convention Marketing and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and Insights Generation plan in close collaboration with the HEOR evidence strategy director and cross functional stakeholders Supports synthesis of available ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...is responsible to work closely with the HEOR Evidence Strategy and Synthesis Director to ensure that… more
- Tris Pharma (Monmouth Junction, NJ)
- …compliant communication between marketing and other cross-functional teams (ie, Medical Affairs , Sales, Regulatory Affairs , Operations, etc.)Collaborates ... distribution, promotion etc.Deep knowledge of the pharmaceutical Legal, Medical, Regulatory review processDemonstrated experience in driving marketing strategy … 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
