- 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… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support ... safety reporting regulations and ICH guidelines and internal procedures. The Associate Director Medical Review will contribute and maintain the safety profile of the… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionWe are seeking a Senior Director (Sr. Principal Scientist) Global Regulatory Affairs Liaison with a visionary, growth-oriented mindset that can help ... follow-up contact with regulatory agencies and/or subsidiaries for all applications and submissions and responsible for regulatory review and final approval for all … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …diseases and immune disorders. Summary Effectively liaise, negotiate and partner with FDA ; direct, coordinate and implement the preparation of all regulatory ... submissions and provide regulatory support across all global projects,...corporate goals.Responsibilities:Liaise, negotiate and orchestrate meetings and teleconferences with FDA ; strategize and plan for FDA meetings;… more
- Merck & Co. (Rahway, NJ)
- …company is seeking a highly motivated candidate for the position of Director , Small Molecule Development within the Mixed Modalities, Sterile Product Development ... for parenteral drug products within the small molecule and synthetic modality pipeline.The Director will report to the Executive Director of Sterile Product… more
- Merck & Co. (North Wales, PA)
- Job DescriptionReports to the Director /Senior Director in the Office of Promotion and Advertising Review (OPAR)The Associate Director is responsible for the ... business objectives.Serve as the liaison and manages correspondence with FDA 's promotional review divisions Office of Promotion and Advertising… more
- Merck & Co. (Rahway, NJ)
- …portfolio. Within Biologics and Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, and develop a team ... compliance mindset and collaboration with various partners and stakeholders in development.The Director will report to the Executive Director of Biologics and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …minutes to capture the full discussion for archiving. Serve as the primary contact with FDA .Lead and prepare FDA submissions , including but not limited to ... of our cutting-edge assets by effectively liaising, negotiating and partnering with FDA . This role will create and implement effective regulatory strategies to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …liaise, negotiate and orchestrate meetings and teleconferences with FDALead and prepare FDA submissions , including but not limited to briefing documents, ... of our cutting-edge assets by effectively liaising, negotiating and partnering with FDA . This role will create and implement effective regulatory strategies to… more
- Tris Pharma (Monmouth Junction, NJ)
- Associate Director / Director , Analytical Research and DevelopmentMonmouth Junction, NJ Analytical Development, R&DDescriptionTris Pharma, Inc. ... Junction, NJ headquarters has an immediate need for an experienced Associate Director / Director , Analytical Research & Development. Job Title commensurate with… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders.Summary The Associate Director , RACMC Portfolio Products, will be responsible for regulatory CMC (Chemistry, ... Regulatory CMC strategies, reviewing CMC information and data, authoring CMC submissions , and interacting with Health Authorities to meet the aggressive timelines… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …providing quality content and review of documents supporting GLP/non-GLP/ Research submissions to Health authorities globally. Provide QA oversight of GLP/GCLP ... ensuring that outsourced obligations are in compliant and prepared for regulatory submissions and / or inspections Ensures that appropriate systems, processes are in… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and this position acts as the company liaison with the Health Authority (eg, US FDA and EU EMA) for assigned projects with support, on CMC matters. This position ... This position develops awareness of global requirements through support of global submissions and this position serves as the RA CMC representative supporting… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …across multiple functional areas. Relationships You will report to the Senior Director - Global Regulatory Portfolio Lead. Essential Functions Serve as a member ... and meeting preparation Lead and/or support global filing activities for submissions Present regulatory strategies including communication of regulatory risks and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of the study during FDA , MHRA, EMA, and PMDA interactions, such as pre- submissions , end of phase 1/2, and inspections- May support the GCL, if applicable, in ... areas centered around rare diseases and immune disorders.Summary The Senior Director sits within Global Oncology Clinical Development, an organization dedicated to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the study during FDA , MHRA, EMA, and PMDA interactions, such as pre- submissions , end of phase 1/2, and inspectionsMay support the GCL, if applicable, in planning ... areas centered around rare diseases and immune disorders. SummaryThe Senior Director sits within Global Oncology Clinical Development, an organization dedicated to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …affairs in providing content and providing review of documents supporting CDx submissions to the FDA and other health authorities globallyFor late-stage ... programs, executes the Diagnostic development strategy for a project under the direction of the GPT CDx representative while keeping abreast of regulatory and policy updates in the external environment and by tracking and understanding the competitive… more
- Insmed Incorporated (San Diego, CA)
- …for Millennials™, and Best Medium Workplaces™ lists.OverviewThe Executive Medical Director of Ophthalmology, Clinical Development holds the responsibility to lead ... interpretation/communication.Author or oversee authorship of clinical sections of regulatory submissions (INDs, briefing books, BLAs, NDAs, etc.) and represent the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …high level strategic input into development plans, study designs, and regulatory submissions . Relationships The Principal Medical Writer reports to a Director ... input into documents and plans to support clinical operations and regulatory submissions across a range of development programs and therapeutic areas: Uses… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support ... at Novo Nordisk, Inc. RelationshipsThe fellow will report to the Fellowship Director throughout the two-year program and will also have a reporting relationship… more
