- 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …QA oversight.Drive innovative process improvements across RD, PV, and Medical Affairs by leveraging emerging technologies and industry best practices.Ability to ... and implement proactive strategies to address data integrity issues identified during regulatory inspections, such as those from Quality Events, Audits Findings and … more
- Merck & Co. (Rahway, NJ)
- …Analysis, Problem Solving, Process Improvements, Project Management, Project Risk Assessments, Regulatory Affairs Management, Regulatory Reporting, ... & International Trade (CIT) Tariff Classification Associate Director, the Senior Specialist will work closely with our Research & Development Division… more
- Merck & Co. (Rahway, NJ)
- …Project Management, Project Management Information Systems (PMIS), Project Risk Assessments, Regulatory Affairs Management, Regulatory Reporting, ... Customs & International Trade (CIT) Valuation Associate Director, the Senior Specialist position's core responsibilities are to oversee our Company's Global… 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, publication, and presentation at national and international meeting.-They will lead cross-functional product development teams that oversee… more
- Merck & Co. (Rahway, NJ)
- 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
- 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) ... for new and existing products to ensure compliance with international regulations. + Coordinate, prepare, and review regulatory...You:** + Minimum BA/BS required. + Minimum 8 years regulatory affairs experience; or a combination of… more
- Stryker (Mahwah, NJ)
- We are currently seeking a ** Senior Manager, Regulatory Affairs ** to join our Joint Replacement Division (Mako and Enabling Technologies Business Unit). ... or Weston, FL with some workplace flexibility. As the ** Senior Manager, Regulatory Affairs ** ,...and cross-functional partners, as well as with individuals across international locations and time zones, cultures, and languages to… more
- Bausch Health (Bridgewater, NJ)
- …creates itwhere your skills and values drive our collective progress and impact. The Senior Specialist Regulatory Affairs executes on the pharmaceutical ... team for agency filing + Work with the Pharmaceutical Regulatory Brand Senior Manager to make certain...Authorities for assigned brand products + Liaise with country-specific regulatory affairs personnel for international … more
- Stryker (Mahwah, NJ)
- …days per week in Mahwah, NJ or Weston, FL. **What you will do** As the ** Senior Regulatory Affairs Specialist** , you will support Stryker's Mako and ... We are seeking a ** Senior Regulatory Specialist** to join our...affairs + Thorough understanding of FDA, Europe, and international medical device regulations + Experience drafting regulatory… more
