- Eisai, Inc (Nutley, NJ)
- …exchange.Maintain scientific credibility and ensure operational excellence (20%) Ensure compliance with regulatory and other ethical guidelines relevant ... If this is your profile, we want to hear from you. The Associate Director (AD), Global Medical Affairs Training and Education is responsible for the planning and… more
- Formation Bio (New York, NY)
- …early development through commercialization. You will oversee internal and external teams, ensure regulatory compliance , and play a key role in scaling our ... development, formulation, analytical methods, and technology transfer to manufacturing sites. Regulatory Compliance & Submissions Ensure all CMC activities… more
- Merck & Co. (Rahway, NJ)
- …change management.Familiarity with United States and European Union GMP and Safety compliance regulations.Ability to convert new drug product attributes and ... Engineering, Chemistry, Clinical Operations, Customer-Focused, Data-Driven Decision Making, Drug Product Development, Estimation and Planning, GMP Compliance ,… more
- Merck & Co. (Rahway, NJ)
- …Innovation, Mentoring Staff, Operating Models, People Leadership, Pharmaceutical Development, Product Design, Product Development, Regulatory CMC, ... and scaling-up the formulation, device, and manufacturing process.- Driving drug product design from the benchtop to current Good Manufacturing Practice (cGMP)… more
- Merck & Co. (Rahway, NJ)
- …Devices, Operational Excellence, People Leadership, Process Analytical Technology (PAT), Product Development, Professional Networking, Regulatory Compliance , ... entirety of our non-sterile and sterile clinical portfolio. The Director is responsible for ensuring cGMP compliance ...for always maintaining a state of inspection readiness.- The Director should be well engaged with regulatory … more
- Merck & Co. (Rahway, NJ)
- …and retaining diverse talent.Extensive knowledge of and hands-on work in applying regulatory guidance and quality standards related to product release and ... Scientists to deliver analytical solutions that enable and accelerate process and product development and manufacturing and ensure safety and quality of our… more
- Merck & Co. (Rahway, NJ)
- …Technology (PAT), Product Development, Professional Networking, Quality Standards, Regulatory Compliance , Regulatory Submissions, Results-Oriented, Risk ... for analytical development of candidates from the discovery interface, through first product registration.- -The Director will be responsible for a team… more
- Merck & Co. (Rahway, NJ)
- …Systems, Quality Management, Quality Oversight, Quality Risk Management, Quality Systems Compliance , Regulatory Compliance {+ 4 more}-Preferred Skills:Job ... as a quality spokesperson on a variety of Quality or compliance -related issues.Identifies trends and/or potential compliance gaps and proactively… more
- Merck & Co. (Rahway, NJ)
- …pipeline programs using fed-batch and continuous manufacturing platforms. The Director , Biologics Process Development (BPD) within the Biologics Process Research ... upstream and downstream processes that produce high yields along with superior product quality and allow speedy progression for clinical studies and commercial… more
- Merck & Co. (Rahway, NJ)
- …Compliance , Supply, Continuous Improvement, and Cost Management.--The Associate Director , External Manufacturing Operations will also assist in commercialization ... - Knowledge of lean principles, equipment design, and preventative maintenance.- Regulatory - Global regulations and compliance requirements governing… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Safety and PharmacovigilanceR&DVendors/ CROs/ third partiesHEOR/ RWEEpidemiology Legal and compliance Marketing/ commercialGMP QA/ Supply chain / Regulatory ... areas centered around rare diseases and immune disorders. JOB SUMMARYThe Senior Director , Head Medical affairs Quality Assurance in Global RD/PV QA is accountable… more
- Merck & Co. (Rahway, NJ)
- …equipment and processes for medical devices/drug delivery systems. Reporting to the Director responsible for this area, you will partake in medical device assembly ... understanding of medical device assembly equipment to enable development of product specific processes and controls with a focus on DFM/DFA principles.Understanding… more
- Merck & Co. (Rahway, NJ)
- …and applying rigorous scientific and ethical standards.-The Distinguished Scientist (Executive Director ) and Product Development Team (PDT) lead, Oncology Global ... the indication of interest.Work closely with a cross-functional Senior/ Executive Director group of experts in commercialization, regulatory affairs, statistics,… more
- Ross Stores, Inc. (New York, NY)
- …learning opportunities and development for our teams\. **GENERAL PURPOSE:** The Director , Product Compliance & Regulatory Attorney will work as a member ... stakeholders on a broad range of topics and projects in the areas of product compliance , regulatory compliance , product safety, environmental, and… more
- Anywhere Real Estate (New York, NY)
- …member of the Global Information Security team, the Director of Risk & Compliance (Data Privacy and Regulatory Compliance ) will spearhead the global data ... development, and operation of technology systems and products. The Director will ensure that data handling practices and information...Foster a culture of data privacy, regulatory compliance , and audit preparedness across the Product … more
- Regeneron Pharmaceuticals (Sleepy Hollow, NY)
- …legal advisor to multiple internal stakeholders, including the commercial, medical affairs, regulatory , HEOR, corporate affairs, and compliance teams. You will ... regulatory landscape. + Counseling on all aspects of product commercialization, including launch preparation, launch execution, market development, disease… more
- Sanofi Group (Morristown, NJ)
- …and Medical Affairs, to ensure labeling content reflects scientific integrity, regulatory compliance , and supports safe and effective product use. We are an ... EU SmPC), ensuring alignment with regulatory requirements and Sanofi's product positioning. The Associate Director contributes to early development… more
- Sanofi Group (Morristown, NJ)
- **Job Title:** Director , Global Regulatory Affairs - Global Labeling Strategy **Location** : Morristown, NJ or Cambridge, MA (Hybrid) **About the Job** Are you ... be critical in helping our teams accelerate progress. The Director , Global Regulatory Affairs - Global Labeling...an active role in shaping labeling strategy early in product development by providing regulatory input into… more
- Citigroup (New York, NY)
- Serves as a senior function/business/ product compliance risk manager for Independent Compliance Risk Management (ICRM) responsible for establishing internal ... Business Execution as well as cross- Client initiatives. **Job Family Group:** Compliance **Job Family:** Product Compliance Risk Management **Time… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- **Job Description Summary** The Associate Director , Regulatory Affairs, Specimen Management (SM) reports directly to the Vice President, Regulatory Affairs, ... and global regulations. **About the Role:** In this role you will lead regulatory strategies and ensure compliance , driving growth and innovation in our… more
