- Daiichi Sankyo, Inc. (Bernards, NJ)
- …direct regulatory affairs experience, including experience in regulatory submissions in OncologyManagerial experienceExperience with ex- US regulatory ... for providing oversight and formulation of strategy for global regulatory submissions in Oncology in the US ,...the product's lifecycle and across different indications. Represent Global Regulatory Affairs on the GPT (Global Project… more
- Merck & Co. (North Wales, PA)
- …including the related SOPs and Execution resources. The incumbent is accountable to Sr. Director of Business Process and Systems with input from VP, CSRM as needed, ... contributing functional areas and process governance committees. Works with Sr. Director for Business Process and Systems, -CSRM to develop and implement… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …robust development plans. The individual will direct, coordinate and implement the preparation of US regulatory submissions and provide US regulatory ... the company's growth, thereby accomplishing corporate goals.ResponsibilitiesDevelop and implement US regulatory strategy for assigned project(s).Strategize and… more
- Merck & Co. (North Wales, PA)
- Job DescriptionOur Diagnostics focused Regulatory Affairs team helps bring new precision medicine advancements to the world by facilitating effective, efficient, ... devices, the majority of which must be in diagnostic regulatory affairs .-Preferred: MS with minimum of 8...in certain states and cities within the United States . Final determinations with respect to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …More Years pharmaceutical industry experience required4 or More Years of direct regulatory affairs experience, including US labeling experience ... US or EU. Preparation of updated Core Data Sheets, and EU and US Documentation: Independently manages, prepares and implements regulatory documents (eg, USPI,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …robust development plans. The individual will direct, coordinate and implement the preparation of US regulatory submissions and provide US regulatory ... the company's growth, thereby accomplishing corporate goals.Responsibilities:Develop and implement US regulatory strategy for assigned project(s). Strategize and… more
- Merck & Co. (North Wales, PA)
- …of all US promotional materials and serving as the promotional regulatory expert with marketing, legal, and medical teams to ensure that promotional practices ... Job DescriptionReports to the Director /Senior Director in the Office of...regulatory consultation in the development and implementation of US marketing strategy and promotional programsSupport the US… more
- Merck & Co. (South San Francisco, CA)
- Job DescriptionHealth Systems Oncology Medical Affairs Director , US Medical Affairs - NorCal, NV, AZThe Health Systems Oncology Medical Affairs ... resource for the HSO MAD Team Lead, HSO Executive Director Medical Affairs , and other members of...in certain states and cities within the United States . Final determinations with respect to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … & Public Policy, this position will help lead Daiichi Sankyo's engagement across the United States to ensure patient access to our current portfolio and robust ... Affairs and Public Policy, develop, lead and prioritize Daiichi Sankyo's legislative and regulatory engagement and strategy in the states and DC, with a focus… more
- Merck & Co. (North Wales, PA)
- …divestment and product withdrawal.Support new technology development.Demonstrate an understanding of regulatory affairs and applies this understanding to the ... Job DescriptionPrincipal Scientist / Director , GLOBAL REGULATORY CMC Biologics (R5)Under...in certain states and cities within the United States . Final determinations with respect to… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Serve on Local Labeling Committee (LLC) and provide medical input to Regulatory Affairs Physical Requirements 20-30% overnight travel required. Position is ... Area in certain instances, at the discretion of Executive Director of Medical Affairs . Assists the Senior...Ideal candidate can be based remote anywhere in the United States , ideally on the East Coast… more
- Merck & Co. (Boston, MA)
- …studies.Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical ... the salary range for this job in certain states and cities within the United States . Final determinations with respect to salary will take into account a… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …TA priorities and business needs. Relationships This position may report into the Field Director , Medical Affairs (or in smaller TA's directly into the TA head). ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...development, CMR is involved. The one thing that keeps us all marching to the same beat is our… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …industry experience required4 or More Years of direct regulatory affairs experience, including CCDS and US /EU labeling experience requiredExperience with ... Years pharmaceutical industry experience required4 or More Years of direct regulatory affairs experience, including US labeling experienceExperience with ex-… more
- Merck & Co. (Washington, DC)
- …the salary range for this job in certain states and cities within the United States . Final determinations with respect to salary will take into account a ... Job DescriptionPosition Description: Associate Director , Policy Strategy and Capabilities The Associate ...AVP, and GPP LT. -The role is based in US (Washington, DC, Philadelphia, PA, Rahway, NJ, Upper Gwynedd,… 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
- Merck & Co. (Rahway, NJ)
- …the salary range for this job in certain states and cities within the United States . Final determinations with respect to salary will take into account a ... part of our company's Social Business Innovation (SBI) department within Corporate Affairs . The ESG team works cross-functionally with senior leaders and partners in… more
- Tris Pharma (Monmouth Junction, NJ)
- …Inc. (www.trispharma.com) is a leading privately-owned biopharmaceutical company in the US with a focus on development and commercialization of innovative medicines ... address unmet patient needs. We have more than 150 US and International patents including applications and have marketed...Tris has an immediate opening for a full-time permanent Director /Senior Director , Clinical Quality Assurance. This is… 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 ... Leads US FDA/EU EMA interactions with support from higher-level manager. Regulatory Knowledge: Demonstrates expert knowledge of US /EU regulatory … 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
