- Merck & Co. (Rahway, NJ)
- …solutions to the world.Looking for someone with a growth mindset.Position Description: The Senior Director , Global Regulatory Lead, is responsible for ... Job DescriptionOur Regulatory Affairs team bring new medical...activities include, but are not limited to:Reports to Executive Director or Associate Vice President, General MedicineDevelops worldwide product… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …appropriateness throughout the product's lifecycle and across different indications.Represent Global Regulatory Affairs on the GPT (Global Project Team), Daiichi ... Years Experience in the pharmaceutical industry7 or more years with direct regulatory affairs experienceExperience in regulatory submissions in… more
- Merck & Co. (Rahway, NJ)
- …monitoring, analysis, regulatory filing, and publication. Specifically, The Senior Clinical Director May Be Responsible For: Evaluating pre-clinical ... Job DescriptionThe Senior Clinical Director (Sr. Principal Scientist)...closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with cross functional teams and various departments to include Marketing, Medical Affairs , Regulatory Affairs , Supply Chain Technical Operations, ... Associate Director , RACMC Portfolio Products, will be responsible for regulatory CMC (Chemistry, Manufacturing, and Controls) activities of the portfolio small… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …including working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub ... applications/supplements & variations (eg, NDA, BLA, MAA). This position authors regulatory documents where necessary with supervision. This position conducts … more
- Merck & Co. (Rahway, NJ)
- … may:Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... projects; and assist the Senior /Executive Clinical Director /Vice-President in ensuring that appropriate corporate personnel is informed of the progress of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …technologies/ Implementing strategic and tactical plans to drive sustainable improvements.Supports Regulatory Affairs in providing quality content and review of ... at key governance meetings whereby GCLP/GLP activities are being discussed ( Regulatory affairs , Research unit LT, GRDC etc.,) Effectively interacts… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …responsible for managing the multiple Clinical Science Asset Leaders (CSALs) at the Senior Director level for each respective program. This Clinical Science (CS) ... collaborate with RD leaders in Clinical Operations, Biostatistics and Data Management, Regulatory Affairs , and other RD functions to ensure effective delivery… more
- Merck & Co. (Rahway, NJ)
- …placement, monitoring, analysis, regulatory reporting, and publication.Specifically, The Senior Director May Be Responsible ForEvaluating pre-clinical and ... with talented and dedicated colleagues while developing and expanding your career.The Senior Director (Sr. Principal Scientist) has primary responsibility for… more
- Novo Nordisk Inc. (New York, NY)
- …coordination with his/er Field Director . Relationships Position reports to Field Director / Senior Field Director . Serves as organization spokesperson on ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...scientific and clinical education and experience. Within Field Medical Affairs , this position functions as a scientific liaison between… more
- Merck & Co. (Rahway, NJ)
- …studies;Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical ... cycle of clinical development, including: study design, placement, monitoring, analysis, regulatory reporting, and publication. Specifically, the Director may be… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …diseases, researching on real-world evidence, and creating hope for all facing illness. The Senior Director , Regulatory Affairs - Clinical (Neuroderm), ... practical, workable plans to facilitate timely drug development and registration. The Senior Director , Regulatory Affairs - Clinical also works directly… more
- Merck (Rahway, NJ)
- …the world. Looking for someone with a growth mindset. **Position Description:** The Senior Director , Global Regulatory Lead, is responsible for development ... **Job Description** Our Regulatory Affairs team bring new medical...but are not limited to:** + Reports to Executive Director or Associate Vice President, General Medicine + Develops… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …throughout the product's lifecycle and across different indications. + Represent Global Regulatory Affairs on the GPT (Global Project Team), Daiichi Sankyo ... Experience in the pharmaceutical industry + 7 or more years with direct regulatory affairs experience + Experience in regulatory submissions in Oncology +… more
- The Mount Sinai Health System (New York, NY)
- …for accreditation and licensure surveys. **RESPONSIBILITIES** In collaboration with Senior Director of Regulatory Affairs , and other system leadership, ... **JOB DESCRIPTION** A member of MSHS regulatory team, the Accreditation Specialist is a key...leader and participant in the systems continuous accreditation and regulatory readiness program. Responsible for providing direction and oversight… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- **Job Description Summary** The Director , Regulatory Affairs , Specimen Management reports directly to the VP Regulatory Affairs , Specimen Management. ... registrations, sustaining support, and regulatory advocacy. The Director , Regulatory Affairs , Specimen Management...orientation - ability to communicate and interact effectively with senior BD business leaders in US and around the… more
- New York State Energy Research and Development Aut (New York, NY)
- … attorney (the "MD-L&R") to join its management team, lead its Legal & Regulatory Affairs ("LRA") team and provide legal advice and strategic counsel with ... being directly responsible for a variety of legal and regulatory affairs activities and deliverables at the...the MD-L&R participates, along with the rest of NYGB's senior team, in formulating and implementing the strategy and… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- …team advancing Regeneron's vibrant pipeline in the area of general medicine within the Regulatory Strategy group in Regulatory Affairs . The incumbent will ... team supporting product development, but also to interact with senior managers in the company on regulatory ... strategies for product development. This management position in Regulatory Affairs involves the ability to lead… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …within the Inflammation TA. You will work closely with the Inflammation Fibrosis Regulatory Affairs (RA) Franchise Lead, Regional Regulatory Liaisons and ... regulatory strategy. + Provide strategic guidance as the Regulatory Affairs Inflammation subject matter expert on cross-functional/cross-regional sub-teams… more
- The Mount Sinai Health System (New York, NY)
- …oversight of major regulatory programs as defined and agreed upon with the Senior Director of the Clinical Trial Operations and the Principal Investigator of ... faculty. InCHOIR faculty are expert in study design, clinical coordination, regulatory approval and management, endpoint and event adjudication and Data Safety… more
