- Merck & Co. (Rahway, NJ)
- …leadership.Remain current in relevant worldwide regulatory guidance and standards. Lead /support/oversee clinical supplies production with respect to device ... applicable regulatory , quality, company, and customer requirements.-This position will lead cross-functional development teams within and external to Device … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …quality standards and timelines and that quality of data is suitable for regulatory submission. The Associate Director will have routine interaction with key ... Directive, and International Conference on Harmonization (ICH) guidelines. The Associate Director is accountable for operational planning and execution at… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …awareness of best practices for reproducible data science, global regulatory requirements, internal guidelines and Standard Operating Procedures (SOPs)- Ensure ... AI/ML deliverables- Contribute, with limited supervision, to documents submitted to regulatory or pricing authorities- Proactively identifies and manages risks in… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Statistical deliverables. Contribute, with limited supervision, to documents submitted to Regulatory or Pricing Authorities. May participate as subject matter expert ... to ensure compliance with the protocol, external/internal standards, applicable regulatory guidelines, Policies, SOPs, and other relevant guidelines. Responsible,… more
- Aequor (Thousand Oaks, CA)
- …and parts, and drive productivity improvementRelated Activities: Participate or lead , when required, multidisciplinary site teams, eg cross functional team, ... root cause analysis lead . Support Lean Transformation and Excellence in Operations process...the equipment-specific calibration, maintenance, & validation as required during regulatory inspections Participate in internal audits and assess in… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Global Head RDPVQA, and oversees multiple levels of direct reports (Directors, Associate Directors, Managers, contractors as applicable) across the Global PV Quality ... Oncology and Specialty Medicine portfolios, in alignment with the business strategy. Lead the PV inspection management activities by ensuring readiness, compliance,… more
- Sanofi Group (Cambridge, MA)
- **Job title: Device Regulatory Lead ( Associate Director)** + Location: Bridgewater, NJ or Swiftwater, PA or Cambridge, MA **About the job** The Global ... thought was possible. Ready to get started? **Main responsibilities** + Serve as Device Regulatory Lead on assigned project teams (early phase, late stage… more
- Merck (Rahway, NJ)
- …current in relevant worldwide regulatory guidance and standards. + Lead /support/oversee clinical supplies production with respect to device component ... lead cross-functional development teams within and external to Device Development. The incumbent must be able to work... Working Group to ensure full integration of the device development activities with the clinical, regulatory ,… more
- Stryker (Portage, MI)
- …More information is available at www.stryker.com . We are currently seeking an ** Associate ** **Manager, Regulatory Affairs** to join our **Acute Care business ... regulatory requirements at the local, state, or federal/ regulatory agency levels. + Lead teams to.... + A minimum of 3 years of Medical Device Quality or Regulatory Affairs experience required.… more
- BD (Becton, Dickinson and Company) (Milpitas, CA)
- …cytometer experience a plus. + Premarket Experience: Experience supporting medical device regulatory submissions; proven experience with application of quality ... manage the performance review, hiring and firing process for Regulatory Affairs professionals under his/her direction. + Lead...in an US FDA/or ISO regulated environment and medical device industry. + EU MDR/IVDR experience. + History of… more
- Sanofi Group (Bridgewater, NJ)
- …the job** The Associate Director, US Advertising and Promotion serves as the regulatory lead on Review Committees (RCs). As the RC Regulatory Affairs ... **Job title: Associate Director, US Advertising and Promotion, Global Regulatory Affairs** + Location: Cambridge, MA or Bridgewater, NJ **About… more
- Guidehouse (Mclean, VA)
- …undoubtedly a transformative time for regulators, developers, and patients. Guidehouse's Regulatory Life Sciences practice is an engine of innovation helping ... pharmaceutical, biotech, medical device , and diagnostic regulators tackle today's challenges, while anticipating...today. Are you up for the challenge? As an Associate Director within the Guidehouse Public Health practice, you… more
- Dr. Reddy's Laboratories (Middleburgh, NY)
- …traditional background. **Job Description** **Job Summary** We are looking for Manager / Lead Associate Quality Control to provide support to the Middleburgh ... options to satisfy unmet medical needs, we are dedicated to helping people lead longer and healthier lives. We are seeking dynamic and energetic individuals ready… more
- Teva Pharmaceuticals (West Chester, PA)
- …registration. This position comes with 4 direct reports (Dir, Sr Manager, Manager & Associate III). The Sr Director, Regulatory Affairs CMC is responsible for ... Senior Director Regulatory Affairs CMC (Biologic Products) Date: Jun 13,...associated with product development including product and process development, device development, analytical methods, formulation development, manufacturing, and labeling.… more
- Novo Nordisk (Princeton, NJ)
- …preparation of the written deliverables that support the clinical development and regulatory requirements of a clinical program. The Associate Director will ... high level strategic input into development plans, study designs, and regulatory submissions. Relationships The Associate Director, Medical Writing (ADMW)… more
- Abbott (Atlanta, GA)
- …working mothers, female executives, and scientists. For years, Abbott's medical device businesses have offered technologies that are faster, more effective, and ... products that help people with chronic pain or movement disorders, our medical device technologies are designed to help people live their lives better and healthier.… more
- Lilly (Concord, NC)
- …procedures, quality processes and controls for the Parenteral manufacturing area. + Lead area tours to support business reviews, regulatory audits, or ... North Carolina which will house warehousing & logistics, parenteral operations, medical device assembly, and packaging, QC laboratories, and support teams to produce… more
- Medtronic (Boston, MA)
- …Medical Education, Global Field Training, Clinical Research, Research and Development, Regulatory and Legal. **A DAY IN THE LIFE - POSITION RESPONSIBILITIES:** ... updated best practices within region + Develops therapy and device operational knowledge and applies this knowledge to processes...as the District Expert and function as the District Lead for simulation + Collaborates with the Global Field… more
- AbbVie (North Chicago, IL)
- …and ensures CMC strategy is closely aligned with the clinical and regulatory development strategy. Lead DevSci cross-functional initiatives and strategies. From ... among ASDT/ALB and various line functions. Partners with Clinical, Regulatory , Operations, Quality, Pre-clinical Safety, and Commercial organizations. Apprises CMC… more
- Lilly (Concord, NC)
- …of the Parenteral/ Device Assembly and Packaging areas as well as lead / assist in operations readiness programs (eg Material procurement and definition, training ... solutions to improve or meet key performance indicators (KPI) for the area. + Lead area tours to support business reviews, regulatory audits, or network… more
