- Daiichi Sankyo, Inc. (Bernards, NJ)
- …throughout the product's lifecycle and across different indications. Represent Global Regulatory Affairs on the GPT (Global Project Team), Daiichi ... Experience in the pharmaceutical industry7 or More Years with direct regulatory affairs experience, including experience in regulatory submissions in… more
- Sun Pharmaceutical Industries, Inc. (Blawenburg, NJ)
- Senior Director , Global Regulatory Affairs Strategy The position will provide regulatory affairs strategic leadership for the company and novel ... individual will be responsible for developing and executing the overall regulatory strategy, which includes developing the registration pathway, interacting with … 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)
- …research, translational biomarkers, companion diagnostics, bioinformatics, clinical development, medical affairs , regulatory etc.).Identify and interact with key ... will interact with the Companion Diagnostics Lead, Non-Clinical Research, Medical Affairs and other stakeholders to support the program. Other responsibilities will… 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
- 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)
- …is part of our company's Social Business Innovation (SBI) department within Corporate Affairs . The ESG team works cross-functionally with senior leaders and ... and healthy future for people and communities everywhere.The role of Associate Director , ESG Strategic Reporting is a unique opportunity to join our company… 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 ( Senior Principal Scientist) has primary responsibility… 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
- 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 ... in the pharmaceutical industry + 7 or More Years with direct regulatory affairs experience, including experience in regulatory submissions in Oncology +… more
- AbbVie (Florham Park, NJ)
- …Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Senior Director Regulatory Affairs Therapeutic Area Head, ... GRS, is responsible for the management of global regulatory leads with product and disease state expertise for specific therapeutic area(s). Provides oversight for… more
- Mount Sinai Health System (New York, NY)
- …CMO - MSH, Mount Sinai Hospital **Responsibilities** In collaboration with Senior Director of Regulatory Affairs , and other system leadership, directs ... **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
- 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
- AbbVie (Florham Park, NJ)
- …Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Director Regulatory Affairs , Strategic Labeling is responsible for ... or Microbiology + Preferred Education: Relevant Master's degree preferred. Certification in regulatory affairs a plus + Required Experience: 10+ years… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …assigned and perform the duties outlined below. This role includes mentoring Regulatory Affairs staff, supporting project teams and development partners, and ... will be responsible for leading the development and execution of global regulatory strategies for biologic products and combination products for the product… more
- 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
- Bristol Myers Squibb (Madison, NJ)
- …. The Medical Director , US Medical, Multiple Myeloma will report to the Senior Director , US Medical Multiple Myeloma Lead. He/she will be headquarter based, ... the US Commercialization organization, WW Medical, Clinical Research and Development, Regulatory , Translational Development, and Market Access, and will lead the US… more
