- 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)
- … regulatory strategy, issues, and risks in written and verbal format to regulatory senior leadership team and other governing bodies required Travel: Ability ... centered around rare diseases and immune disorders. Summary: Responsibility for regulatory strategy to support the development of biomarkers, companion diagnostic… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders. JOB SUMMARYThe Senior Director, Head Medical affairs Quality Assurance in Global RD/PV ... strategy and quality plan closely aligned with the Global Oncology Medical Affairs (GOMA), Oncology Business Unit (OBU) and Specialty Business Unit (SBU) Medical… more
- Merck & Co. (North Wales, PA)
- …--Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... create breakthrough science that radically changes the way we approach serious diseases. --The Senior Director will report to an Associate Vice President in the… 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 ... including development strategy, study design, initiation, execution, monitoring, analysis, regulatory reporting, and publication.Specifically, the Senior Director… more
- Merck & Co. (North Wales, PA)
- Job DescriptionRole SummaryUnder the guidance of a senior leader, an Associate Principal Scientist/ Associate Director, has primary responsibility for ... is expected to work cross-functionally with clinical development, medical affairs , biostatistics, market access, commercial and country affiliates. The incumbent… more
- Merck & Co. (Rahway, NJ)
- …Analysis, Problem Solving, Process Improvements, Project Management, Project Risk Assessments, Regulatory Affairs Management, Regulatory Reporting, ... Job DescriptionReporting to the Customs & International Trade (CIT) Tariff Classification Associate Director, the Senior Specialist will work closely with our… more
- Merck & Co. (Rahway, NJ)
- …Project Management, Project Management Information Systems (PMIS), Project Risk Assessments, Regulatory Affairs Management, Regulatory Reporting, ... DescriptionDescription Reporting to the Customs & International Trade (CIT) Valuation Associate Director, the Senior Specialist position's core responsibilities… more
- Merck & Co. (Boston, MA)
- …Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... strategy and design, protocol authoring, initiation, execution, monitoring, analysis, regulatory reporting, publication, and presentation at national and international… more
- 3M (Austin, TX)
- Job Description: Senior Regulatory Affairs Associate Collaborate with Innovative 3Mers Around the World Choosing where to start and grow your career has ... environments to a 3M career. The Impact You'll Make in this Role As a Senior Regulatory Affairs Associate , you will have the opportunity to tap into… more
- 3M (Maplewood, MN)
- Job Description: Senior Regulatory Affairs Associate Collaborate with Innovative 3Mers Around the World Choosing where to start and grow your career has ... experience to a 3M career. The Impact You'll Make in this Role As an Senior Regulatory Affairs Associate , you will have the opportunity to tap into… more
- Daiichi Sankyo Inc. (Basking Ridge, 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
- Boehringer Ingelheim (Ridgefield, CT)
- …business impact. The Senior Associate Director, US Product CMC Regulatory Affairs is responsible for the direction, coordination and execution of all ... people. The Associate Director, US Product CMC Regulatory Affairs is responsible for the coordination...concerning assigned US investigational and marketed product interactions. The Senior Associate Director position is expected to… more
- University of Colorado (Aurora, CO)
- ** Regulatory Affairs Coordinator (Open Rank: Entry/Level 1 Senior /Level 3)** **Description** **University of Colorado Anschutz Medical Campus** **Department: ... Cancer Center** **Working Title: Regulatory Affairs Coordinator (Open Rank: Entry/Level 1 - Senior...Clinical Research Professional + CCRA - Certified Clinical Research Associate **Knowledge, Skills and Abilities:** + Ability to problem… more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …position to act as a team member in the product manager area of Regulatory Affairs (Biopharma) supporting global submissions for various areas of the business. ... Specialist I_** **Primary responsibilities for role:** + Act as Regulatory Affairs representative for specified key products/facilities/equipment. + Prepare… more
- Kelly Services (Sunnyvale, CA)
- Kelly(R) Science & Clinical is seeking a Senior Regulatory Affairs for a one-year contract opportunity with a leading molecular diagnostics company based in ... Onsite in Sunnyvale, CA or Remote US **Position Title:** Senior Regulatory Affairs Specialist, New...labeling accuracy for Cepheid's in vitro diagnostic products. The associate will have an opportunity to collaborate and partner… more
- Lilly (Indianapolis, IN)
- …in drug development. The purpose of the Associate Vice President - Global Regulatory Affairs , Global Regulatory Policy & Strategy (Genetic Medicine and ... regulatory excellence attributes as described in Global Regulatory Affairs white papers + Engage in...guided by industry norms and business strategy + Influence senior leadership, regulators, and/or external partners on business and… more
- Takeda Pharmaceuticals (Boston, MA)
- …is possible in order to bring life-changing therapies to patients worldwide. The Associate Director, Global Regulatory Affairs Advertising and Promotion (GRA ... medicine promotion. **How you will contribute:** + As our Associate Director, Global Regulatory Affairs ...if there is new data or campaigns that require senior level management input or alignment. + Strategic business… more
- AbbVie (Mettawa, IL)
- …Instagram, YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Associate Director, Regulatory Affairs US Advertising and ... 6 years of relevant industry experience. Certification a plus + Experience in US Regulatory Affairs Advertising and Promotion preferred + Experience working in a… more
- Lilly (Indianapolis, IN)
- …who are determined to make life better for people around the world. **Purpose:** The Senior Director of Global Regulatory Affairs - CMC (GRA-CMC) leads and ... manages the scientific and regulatory efforts of the team, overseeing CMC ...strategies for both development and commercial products. Additionally, the Senior Director is committed to fostering continuous improvement in… more
