- Daiichi Sankyo, Inc. (Bernards, NJ)
- …or More Years in the pharmaceutical industry preferred1 or More Years in regulatory affairs requiredExperience in (s)NDA/BLA filing to FDA preferred Travel ... 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Years pharmaceutical industry experience required4 or More Years of direct regulatory affairs experience, including US labeling experience requiredExperience ... This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational leadership on product… more
- Merck & Co. (Rahway, NJ)
- …and solutions to the world.Looking for someone with a growth mindset. The Director , Regulatory Affairs Liaison is responsible for:Developing regulatory ... Job DescriptionOur Regulatory Affairs team bring new medical...activities include, but are not limited to:Reports to Executive Director or Associate Vice President, Therapeutic Area… more
- Merck & Co. (Rahway, NJ)
- …include, but are not limited to:Reports to Executive Director or Associate Vice President, General MedicineDevelops worldwide product regulatory strategy to ... Job DescriptionOur Regulatory Affairs team bring new medical...for someone with a growth mindset.Position Description: The Senior Director , Global Regulatory Lead, is responsible for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as other research areas centered around rare diseases and immune disorders.Summary The Associate Director , RACMC Portfolio Products, will be responsible for ... with cross functional teams and various departments to include Marketing, Medical Affairs , Regulatory Affairs , Supply Chain Technical Operations,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders.Summary: The Associate Director , Regional Marketing Conventions & Field Programs will be ... and more, while ensuring adherence to DS policies and procedures. The Associate Director , Regional Marketing Conventions & Field Programs is responsible… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders. Summary: The Associate Director will lead the execution and lifecycle management of ... Global Medical Affairs ' externally sponsored clinical research (ESR) initiatives, ensuring strict...as well as alliance partners, promoting a cohesive team approach. Regulatory and Safety Compliance: Understand study conduct from supply… 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)
- …include: Clinical Operations, Clinical Development, Biostatistics and Data Management, Regulatory Affairs , Quantitative Clinical Pharmacology, Clinical Safety ... and Pharmacovigilance, Regulatory /Risk Management, Quality Assurance, Medical Affairs , Translational Research, Research, Informatics Services, Project Management and… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionUnder minimal guidance of the Executive Director / Director / Associate Director , Pharmacovigilance (PV) Partner Strategy & Management ... PV plans, and SMPs.Maintains, in collaboration with the Executive Director / Director / Associate Director ...with all levels of management within and outside of-Global Regulatory Affairs and Clinical Safety (GRACS).Interact closely… more
- Merck & Co. (North Wales, PA)
- …We are currently recruiting for someone to join our US marketing team as the Associate Director , Product Marketing Owner - HCP for the HIV Franchise.The HCP ... ownership of Brand and HCP Strategy and Execution. This position will report to the Director , US Commercial Leader (USCL) and will be based in the Upper Gwynedd, PA… more
- Merck & Co. (Rahway, NJ)
- …Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... regulatory filing, and publication. Specifically, The Senior Clinical Director May Be Responsible For: Evaluating pre-clinical and translational work for… more
- The George Washington University (Washington, DC)
- …in medicine, public health, law, engineering, education, business, and international affairs . Each year, GW enrolls a diverse population of undergraduate, graduate, ... and public service mission of the University.Reporting administratively to the Associate Vice President, accountable to the Board of Trustees, the President,… more
- Fidelity TalentSource LLC (Boston, MA)
- …Chief Financial Officer. You will share best practices in executive communications, associate engagement, and change management, as well as work with leaders (and ... enterprise. This role partners closely with colleagues across Corporate Affairs including Fidelity Communication Services, Corporate Services Alignment, Leader… more
- Taiho Oncology (Princeton, NJ)
- Associate Director , Regulatory Affairs Operations Pleasanton, CA, USA * Princeton, NJ, USA Req #386 Tuesday, August 20, 2024 Looking for a chance to make ... Join our dynamic and expanding mid-size oncology company in the role of Associate Director , Regulatory Affairs Operations where you will utilize your… more
- Abbott (Alameda, CA)
- …to work for diversity, working mothers, female executives, and scientists. **The Opportunity** This ** Associate Director Regulatory Affairs - APAC** will ... CA, location in the Diabetes Division. As a manager, the function of an Associate Director Regulatory Affairs , APAC (Asia Pacific) is to combine… more
- Ascendis Pharma (Palo Alto, CA)
- …We offer a dynamic workplace for employees to grow and develop their skills. The Associate Director , Regulatory Affairs will be responsible for ... are technically complex and require extensive interaction with departments outside of regulatory affairs . + Excellent organizational skills and ability to work… more
- Abbott (Alameda, CA)
- …to work for diversity, working mothers, female executives, and scientists. **The Opportunity** This ** Associate Director Regulatory Affairs - US New ... is helpful. + Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.) + Previous experience with 510k / PMA / DeNovo submissions… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- The Associate 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… more
- Schrodinger (Cambridge, MA)
- We're seeking an ** Associate Director of Regulatory Affairs ** with expertise in hematology and oncology to join our Early Clinical Development team in ... New York or Cambridge, MA. This hire will report to the Director of Regulatory Affairs and will play an essential role in the regulatory activities of… more
