- Novo Nordisk Inc. (Plainsboro, NJ)
- …for a living. Are you ready to make a difference? The Position The Associate Director , Regulatory Affairs - Advertising & Promotion will provide strategic ... Establish strong and positive working relationship with OPDP reviewers. Report to Senior Director , Regulatory Affairs - Advertising & Promotion. Essential… more
- Genmab (Plainsboro, NJ)
- …authentic is essential to fulfilling our purpose.The RoleGenmab is looking for an Associate Director , Global Regulatory Affairs , Regulatory Strategy to ... be a part of our Global Regulatory Affairs organization.In this role, you will...on a compound in late-stage development to implement the US regulatory strategy for multiple new indications.… more
- Merck & Co. (Rahway, NJ)
- …Drug-Device Combinations CMC (Chemistry, Manufacturing & Controls), you will report to the Director of Device Regulatory Affairs for Autoinjector Development ... device design control activities and documentation reviewsProvide evaluations of regulatory state of affairs of any devices...in certain states and cities within the United States . Final determinations with respect to… more
- Genmab (Plainsboro, NJ)
- …looking for an experienced and passionate leader to be a part of our Global Regulatory Affairs (GRA) organization.In this role, the regulatory leader will be ... per our hybrid policy.ResponsibilitiesReporting to the Team Lead of Regulatory Strategy, Global Regulatory Affairs ,...health authorities as appropriate Monitor and assess global and US regulatory guidelines and regulations and current… 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
- Genmab (Plainsboro, NJ)
- …patient information) for the Genmab portfolio of products. This role will be within Global Regulatory Affairs (GRA) and will report to the Sr Director , ... documents including Company Core Data Sheets (CCDS), Core Safety Information (CSI), United States Package Inserts (USPI), Summary of Product Characteristics… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Global Regulatory Affairs and Clinical Safety Global Process Lead is responsible for overseeing and managing Global Regulatory Affairs ... maps, and risk management for global processes across Global Regulatory Affairs and Clinical Safety . The...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)
- …leader will be responsible for bringing the issue and potential solutions to the Head of US Regulatory Affairs in conjunction with the assigned US RA ... accountable for ensuring consistent and transparent ways of working across the Alliance within US regulatory affairs and will work closely with the US … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and immune disorders. Summary: Responsible for leading and developing global regulatory strategy for assigned development projects. Represents Daiichi Sankyo's ... regulatory group in internal and external development project meetings....the Oncology drug development preferred.Ability to interpret and understand US regulations governing the pharmaceutical industry; general global knowledge… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Experience Qualifications7 or More Years in the pharmaceutical industry4 or More Years in regulatory affairs , NDA, sNDA, BLA filing to FDA Travel Ability to ... and partner with FDA; direct, coordinate and implement the preparation of all regulatory submissions and provide regulatory support across all global projects,… more
- Genmab (Plainsboro, NJ)
- …to be our best, and authentic is essential to fulfilling our purpose.The Role The Director of US Medical Affairs Solid Tumors Strategy will report to ... the Senior Director , US Medical Affairs Solid...through collaboration with US Commercialization, Global Medical Affairs , Clinical Development, Regulatory , and other cross… more
- Tris Pharma (Monmouth Junction, NJ)
- …in positions of increasing technical and strategic responsibilityExcellent working knowledge of regulatory and industry standards related to Medical Affairs role ... Tris Pharma, Inc. (www.trispharma.com) is a leading privately-owned US biopharmaceutical company with a focus on development...opening for a Head, Medical Science Liaisons (MSLs) / Director , Medical Training for our Pain division. This is… more
- Tris Pharma (Monmouth Junction, NJ)
- …compliant communication between marketing and other cross-functional teams (ie, Medical Affairs , Sales, Regulatory Affairs , Operations, etc.)Collaborates ... Inc. (www.trispharma.com) is a leading privately-owned biopharmaceutical company in the US with a focus on development and commercialization of innovative medicines… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … business needs Contributes to strategy and development of content for US regulatory submissions regarding PED and patient-relevant endpoints and participates ... of standards and best practices for PED throughout the US organization. Relationships The Director -Patient Centered Outcomes...in US regulatory discussions and negotiations to optimize… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …sales, medical/CMR, legal, compliance, and regulatory . Other internal relationships include Public Affairs , Government Affairs & US Corp Giving & Social ... and personal development. Are you ready to maximize your potential with us ? The Position Responsible for developing patient solution strategies that maximize access… 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 reporting, and publication. - Specifically, the Senior Director may be responsible for Evaluating pre-clinical and translational...in certain states and cities within the United States . Final determinations with respect to… more
- Merck & Co. (Rahway, NJ)
- …a cross-functional Senior/ Executive Director group of experts in commercialization, regulatory affairs , statistics, medical affairs and manufacturing to ... to provide the safety and efficacy data required for regulatory approval of potential new drugs and new indications...in certain states and cities within the United States . Final determinations with respect to… more
- Genmab (Plainsboro, NJ)
- …of this role will include stakeholders in the business domains Field Operations, Medical & Regulatory Affairs and US and Japan Market and Commercial Teams ... and IT&D leaders, with a main focus in the United States .IT&D Partner: Acts as security partner...TeamBusiness leaders (eg, VP Medical Affairs , VP Regulatory Affairs , GM Genmab US ,… 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 ... 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
