- Daiichi Sankyo, Inc. (Bernards, NJ)
- …plans, ensuring appropriateness throughout the product's lifecycle and across different indications.Represent Global Regulatory Affairs on the GPT ( Global ... with direct regulatory affairs experienceExperience in regulatory submissions in OncologyManagerial experience preferredExperience with global … 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 ... support of global submissions and this position serves as the RA CMC representative supporting company initiatives (liaison with PhRMA, USP, ICH, due diligence,… 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 ... corporate standards and policies and business objectives.Actively participate in labeling and global regulatory team meetings to ensure support for anticipated… more
- Merck & Co. (North Wales, PA)
- …placement, monitoring, analysis, regulatory reporting, and publication.- Specifically, the Senior Director may be responsible for: Providing scientific and ... medicines span all phases of clinical development (pre-clinical to post-licensure). The Senior Director will manage the entire cycle of clinical development,… 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)
- …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
- 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)
- …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)
- … 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
- Merck & Co. (North Wales, PA)
- …studiesWork 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
- Merck & Co. (North Wales, PA)
- …have managerial responsibilities of ADT Leaders or Team Members that could include Executive Director , Senior Director , or Director level personnel ... Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development… 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …development (R&D), clinical trials, regulatory affairs , or medical affairs Leadership Experience: Proven track record in senior Leadership roles, such ... securing execution of the following projects according to the Global Project Framework including the medical development strategies reflected...as Director or Senior Director of a drug development function… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …affairs , market access and policy/advocacy (MAPA), Centers of Excellence (COEs), regulatory affairs , other relevant NNI departments, and external stakeholders ... life cycle activities Health Systems strategy: Collaborates with medical affairs and market access teams to inform a health...office and 2 days remote. Approximately 20-30% overnight travel. Global Job level: Director Development of People… more
- Lilly (Indianapolis, IN)
- …for people around the world. Purpose: The purpose of the Senior Director /Executive Director , Global Regulatory Affairs , Global Regulatory ... leadership behaviors and regulatory excellence attributes as described in Global Regulatory Affairs white papers. + Participatein… more
- Danaher Corporation (Raleigh, NC)
- …Global Quality and Regulatory Affairs . The Director of Global Regulatory Affairs will be responsible for developing and executing ... human health. This position is part of Quality and Regulatory Affairs located in Fargo, ND and...ensuring accuracy, completeness, and timeliness. + Monitor and interpret global regulatory requirements and trends, provide strategic… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …ensuring appropriateness throughout the product's lifecycle and across different indications. + Represent Global Regulatory Affairs on the GPT ( Global ... responsible for providing oversight and formulation of strategy for global regulatory submissions in Oncology in the...pharmaceutical industry + 7 or more years with direct regulatory affairs experience + Experience in … more
- AbbVie (North Chicago, IL)
- …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...may develop and implement policies and procedures within the RA department and ensures direct reports follow requirements. Ensures… more
- Gilead Sciences, Inc. (Foster City, CA)
- …co. Gilead is a patient centric, science focused company. Reporting to the Executive Director of Global Medical Affairs , Insights, Digital and Analytics this ... not limited to: + Partner with stakeholders (eg, Medical Affairs , Business Conduct, Development, Regulatory Affairs...advise in cross functional governance, standards and SOPs for global MA digital assets and capabilities + Lead digital… more
- Lilly (Indianapolis, IN)
- …right patient using model-informed drug research and development (MIDD). We are seeking a Senior Director to lead a group of PKPD Project Leaders in advancing ... standards and streamline business practices. + Review and approve PK/PD global regulatory submissions and responses, Tox/Drug Disposition/PKPD or Clinical… more
