- Boehringer Ingelheim (St. Joseph, MO)
- …as governance review, project team meetings, planning activities and FDA communications. Associate Director Act as Regulatory Affairs (RA) core or subteam ... **Description** Manager The Manager, Regulatory Affairs (RA) Pharma Safety &...Responsible for the safety and efficacy part of the dossier for new veterinary products as well as life-cycle… more
- ThermoFisher Scientific (Greenville, NC)
- …biopharmaceutical company, all while maintaining full-time benefits. **Position Summary** The Director , Clinical Regulatory Affairs serves as a ... to regulatory RFIs to support timely trial startup and advancement. The Director , Clinical Regulatory Affairs partners closely with Clinical Operations,… more
- Astellas Pharma (Northbrook, IL)
- …work are encouraged to apply. **Purpose and Scope:** We are seeking an experienced CMC Regulatory Affairs Director with deep expertise in the United States ... external forums. This position plays a key global leadership role in the Regulatory Affairs department for the Chemistry, Manufacturing and Controls (CMC)… more
- Boehringer Ingelheim (Duluth, GA)
- …and benefit programs reflect Boehringer Ingelheim's high regard for our employees. The Director , US Regulatory Affairs Pharmaceuticals leads the US ... products in accordance with company priorities and governance. The Director , US Regulatory Affairs Pharmaceuticals...+ Is responsible for maintaining up to date technical regulatory data and information for use in dossier… more
- Takeda Pharmaceuticals (Boston, MA)
- …CMC strategy. + Guide the team to define and drive strategy for CMC regulatory dossier content and reviews this content for conformance with established ... as follows: + Independently develops and leads the execution of regulatory CMC investigational, registration and/or post-approval strategies for assigned products as… more
- Boehringer Ingelheim (Athens, GA)
- … Director , RA Service Center will hold full accountability for the Regulatory Affairs (RA) US outsourcing program, ensuring its successful execution and ... RA US outsourcing program, executed in collaboration with External Regulatory Affairs Services (ERAS). The program supports...DCP, MRP), and non-EU regions. + Proven expertise in dossier compilation and the use of regulatory … more
- Novo Nordisk (Plainsboro, NJ)
- …+ Serve on Local Labeling Committee (LLC) and provide medical input to Regulatory Affairs Physical Requirements 20-30% overnight travel required. 30% overnight ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...Area in certain instances, at the discretion of Executive Director of Medical Affairs . Assists the Senior… more
- Sanofi Group (Cambridge, MA)
- … Affairs , Clinical Outcomes Assessment (COA), Health Value Translation (HVT) and Regulatory Affairs + Public Affairs , Communications + Compliance and ... **Job Title:** Director , HEVA (HEOR) Business Partner **Location:** Cambridge, MA...The incumbent will interface with market access, Clinical, Medical Affairs , and commercial teams including Global and US. The… more
- Sanofi Group (Morristown, NJ)
- …Development Plan (in close cooperation with other members of the team, particularly Regulatory Affairs and Health Economics); adjusts and updates the strategy ... **Job Title:** Senior Clinical Research Director **Location:** Morristown, NJ Cambridge, MA **About the...in the project in collaboration with the Safety Officer, Regulatory Strategist, Statistics and other key functional representatives to… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- …consistent with the Clinical Development Plans (CDP); clinical components of regulatory documents/registration dossier and brand related medical information, ... The Senior Medical Director , Clinical Development provides clinical leadership and is...MD and frequently lead interactions with external stakeholders (eg, regulatory authorities, key opinion leaders, advisory boards, patient advocacy… more
- Cardinal Health (Helena, MT)
- …capacities, including: + Global Regulatory Strategy Development + Global Regulatory Affairs + Chemistry Manufacturing and Controls Development + Nonclinical ... success in obtaining the greatest market share possible. The Director , Business Development with Cardinal Health Regulatory ...+ Clinical Development and Research + Medical Writing + Regulatory Publishing + Dossier Services + Submission… more
- Otsuka America Pharmaceutical Inc. (Princeton, NJ)
- The Associate Director of Health Economics & Outcomes Research (HEOR) is a strategic and technical leadership role within Otsuka's OPDC, reporting to the Data and ... traditional as well as novel data sources and methodologies. The Associate Director will ensure the successful implementation and delivery of programs through robust… more
- Otsuka America Pharmaceutical Inc. (Princeton, NJ)
- …new products. Preferred **Knowledge and skills** + Solid understanding of pharmaceutical regulatory affairs , global labeling regulatory requirements and ... Drive Labeling Strategy, in-line with overall global regulatory strategy, by providing labeling expertise for Company Core Data Sheet (CCDS), USPI and local labeling… more
- AbbVie (North Chicago, IL)
- …with multiple driver indications within a Therapeutic Area and supports the Manager (Global Regulatory Lead (GRL), Associate Director , or Director ), in the ... Advise internal customers who may contribute to regulated communication on Regulatory /FDA issues including Public Affairs , Clinical Development, Legal, and… more
- Taiho Oncology (Princeton, NJ)
- …operational expertise, managing diverse cross-function teams across Medical Affairs (Medical Information, Scientific Communication and Content, External Research, ... Business Operations. The position will interface across all Medical Affairs Leadership Taiho companies/TPC, and cross functional leadership including, Commercial,… more
- Amgen (Washington, DC)
- …Research (HEOR) Senior Manager, Oncology** **What you will do** Reporting to the HEOR Director , the HEOR Senior Manager is accountable for executing on the HEOR Book ... to support Health Technology Assessment (HTA) submissions, including the Global Value Dossier (GVD) and economic models The HEOR Senior Manager role involves… more