- 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. (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. (Rahway, NJ)
- …Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... Job DescriptionThe Senior Director ( Sr . Principal Scientist) has...including development strategy, study design, initiation, execution, monitoring, analysis, regulatory reporting, and publication.Specifically, the Senior Director… 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. (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. (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
- 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
- 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
- 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
- United Therapeutics (Eden Prairie, MN)
- …or pharma regulatory experience with a Bachelor's Degree in life sciences, quality, regulatory affairs or a related area of study or 10+ years of biologic ... experience with a Master's Degree in life sciences, quality, regulatory affairs or a related area of...Ability to mentor, coach, guide, and train lower to senior level employees **Preferred Qualifications** + Proficient knowledge of… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …regulatory strategy, issues, and risks in written and verbal format to regulatory senior leadership team and other governing bodies required **Travel:** ... around rare diseases and immune disorders. **Summary:** Responsibility for regulatory strategy to support the development of biomarkers, companion diagnostic… 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
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- **Job Description Summary** As Senior Manager, International Regulatory Affairs , you will be responsible for Central Asia, South Asia, and Japan (CASAJ) and ... and revenue drivers. You will manage priorities and provide associate guidance and development. **Job Description** **We are the...You:** + Minimum BA/BS required. + Minimum 8 years regulatory affairs experience; or a combination of… more
- Johns Hopkins University (Baltimore, MD)
- …providers and staff within the Johns Hopkins University School of Medicine. The Sr . Director collaborates with senior leadership, faculty, and staff to ensure ... Affairs (VDCA)/President of the CPA (dual role), the Associate Dean of Clinical Affairs (ADCA), and...Sr . Director, Office of Vice Dean of Clinical Affairs & Faculty Practice Plan Role/Level/Range: L/05/LI Starting Salary… more
- Boehringer Ingelheim (Ridgefield, CT)
- …DO, Ph.D., Master's) preferred + Specialized Pharmacist or Master of Drug Regulatory Affairs , RAC certification preferred ** Associate Director Experience ... Group RA, US RRL role will provide experienced US regulatory strategic input to the global and US cross-functional...Director role and between $170,000 and $269,000 for the SR Associate Director role. The position may… more
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