- Twist BioScience (South San Francisco, CA)
- The Regulatory Operations Specialist is responsible for ensuring the efficient and compliant management of regulatory documentation, with a primary focus on ... combination of education and work-related experience. Minimally 2 years of experience Regulatory Operations within a biotechnology, life sciences, or chemical… more
- Merck & Co. (Millsboro, DE)
- …Management, Regulatory Affairs Compliance, Regulatory Affairs Management, Regulatory Compliance, Regulatory Operations , Regulatory Strategy ... Job DescriptionSUMMARY OF POSITIONThis position is responsible for ensuring regulatory filings of animal health products in pursuance of licensure and marketed… more
- Merck & Co. (Rahway, NJ)
- …Policy Implementation, Regulatory Affairs Compliance, Regulatory Compliance, Regulatory Labeling, Regulatory Operations , Regulatory Submissions, ... Required experience and skills: Min. 5-10 years of experience with Pharmaceutical Regulatory Affairs Operations with Labeling Process and/or Digital Enablement… more
- Merck & Co. (Rahway, NJ)
- …integration and partnering for Pharmaceutical development/ CMC with Quality, Regulatory , Operations , Non-clinical, Clinical, and other functional areasExperience ... formulation, manufacturing process, and primary packaging to enable phase appropriate regulatory filings for large molecule sterile products. -These sterile products… more
- Merck & Co. (Rahway, NJ)
- …CMC.- Strong understanding of integration and partnering with Quality, Regulatory , Operations , Non-clinical, Clinical, and other functional areas.Demonstrated ... packaging, compatibility characterization for processing and administration, and supporting regulatory filings.Collaborate with key stakeholders across the organizations (Research… more
- Merck & Co. (Rahway, NJ)
- …safety programs.Stay current with industry trends, emerging technologies, and regulatory changes impacting HVAC operations in pharmaceutical environments.Prepare ... for leading and developing a team that supports HVAC operations and system infrastructure at the Rahway (RY) NJ...Campus. - This role ensures HVAC systems comply with regulatory standards (eg, FDA, cGMP), maintain optimal environmental conditions… more
- Merck & Co. (Upper Gwynedd, PA)
- …Pharmaceutical CMC is responsible for developing and implementing CMC regulatory strategies for our company's pharmaceutical pipeline products in accordance ... assigned development products. -Primary responsibilities include, but are not limited to: Regulatory Responsibilities: Serve as a CMC Product Lead for assigned… more
- Eisai, Inc (Nutley, NJ)
- …role ensures studies are conducted efficiently, within budget, and in compliance with regulatory standards. The Head of Clinical Operations leads teams of study ... operations components. Key Responsibilities:Manage and oversee the clinical operations function, ensuring compliance with GCP and regulatory … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disordersJob Summary: The Regulatory Process Manager will be a key member of the Global Regulatory ... Process Excellence & Analytics function, responsible for ensuring Daiichi Sankyo's Regulatory processes & procedural documentation are fit for purpose and compliant… more
- Merck & Co. (Millsboro, DE)
- …is a Biotechnology Center of Excellence that performs vaccine production operations from antigen production through formulation, filling and packaging. With ... position is responsible for overseeing late-shift activities to support the Sterile operations and Logistics Integrated Process Team (IPT) up to and including… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Director of Operations as part of the Technical Operations team based in Raritan, ... NJ. Role OverviewThe Director of Operations is an exempt level position...controls, and maintain permanent inspection readiness and actively support regulatory inspections.Lead facility operating review meetings and sponsor various… more
- Merck & Co. (Rahway, NJ)
- …critical role in driving member satisfaction, improving efficiencies, and ensuring regulatory compliance while advancing the credit union's payments strategy in ... with overall business goals and member needs.Monitor industry trends, emerging technologies, and regulatory changes to keep the credit union on the cutting edge of… more
- Merck & Co. (Durham, NC)
- …Process, Operational Excellence, Process Optimization, Process Troubleshooting, Production Operations , Production Support, Project Management, Regulatory ... your career.We have an exciting opportunity for a Specialist to join the operations team supporting a capital project critical to Human Health at our facilities… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Merck & Co. (North Wales, PA)
- …engagements. This includes the ability to:Solid knowledge of clinical research regulatory requirements (eg, GCP and ICH)Ability to manage multiple competing ... DayValid Driving License:NoHazardous Material(s):NoRequired Skills:Adaptability, Adaptability, Clinical Data, Clinical Operations , Clinical Outcomes, Clinical Research, Clinical Study Design, Clinical… more
- Insmed Incorporated (San Diego, CA)
- …for Millennials™, and Best Medium Workplaces™ lists.OverviewLead Analytical Development Operations function to build out the process development support testing ... lead on a PDT as required by the business.ResponsibilitiesThe Analytical Development Operations associate director is responsible for building a team to take care… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Eisai, Inc (Exton, PA)
- …and close-out reports for Biologics Pilot Plant campaigns. Support providing data for regulatory documents as required.7. Ensure adherence of operations to cGMP, ... profile, we want to hear from you. The Associate Director of Biologics Operations Upstream and Downstream is responsible for leading and building a scientific team… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …individuals in other NNI departments, including but not limited to Medical, Regulatory , Marketing, Sales, Commercial Operations , and Ethics, Compliance & ... Privacy. May interact with government agencies, law firms, trade organizations and other external agencies. Reports to a Managing Assistant General Counsel. Essential Functions In collaboration with other attorneys, serves as a legal advisor for assigned… more
