- 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 ... higher-level manager. Regulatory Knowledge: Demonstrates expert knowledge of US/EU regulatory guidances. Serves as RA CMC representative supporting company… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …UK and Switzerland. CDx RA Strategy : Align strategy with lead CDx RA representative(s) and represent Global CDx Regulatory position and provide input and ... centered around rare diseases and immune disorders. Summary: Responsibility for regulatory strategy to support the development of biomarkers, companion diagnostic… more
- Eisai, Inc (Nutley, NJ)
- …your profile, we want to hear from you. Job Summary The Executive Director, Regulatory Affairs will provide leadership and direction for the global regulatory ... least 12 years industry experience with a minimum of 10 years direct Regulatory Affairs experience in the biotech/biopharmaceutical industry. Education area of… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … agencies. Supervise designated personnel. Relationships Report to the Director Regulatory Affairs . Develop and maintain positive rapport and working ... relationships with other personnel in Regulatory Affairs , CMR, and other local and headquarter departments to accomplish company goals. External relationships… more
- Pall (Miami, FL)
- …System which makes everything possible.Director Global Quality and Regulatory ComplianceJOB SUMMARYInterprets federal/state/international regulations as they apply ... of regulations, devises strategies for compliance, and liaison with regulatory bodies. Investigates and resolves compliance problems, questions and complaints.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … Regulatory Process Manager will be a key member of the Global Regulatory Affairs (GRA) Process Excellence & Analytics function, responsible for ensuring ... and compliant with relevant regulations. This role will work with Global Regulatory Affairs and cross-functional teams (eg, Quality, CSPV, Clinical Operations,… more
- Eisai, Inc (Raleigh, NC)
- …or site manufacturing changes in collaboration with Product Quality, Regulatory Affairs , and Technical Operations.Establish productive business relationships ... interface experiences with the Finance, commercial Sales and Marketing organizations, regulatory affairs , and with third party manufacturers.Strong knowledge of… more
- Merck & Co. (Rahway, NJ)
- …the Final Study Report Maintain contact with all stakeholders (project leader, regulatory affairs , quality assurance etc.) and keeps them informed of ... and report clinical laboratory and field studies that will support the regulatory approval of new companion animal and livestock products. The position requires… more
- Merck & Co. (Rahway, NJ)
- …with key stakeholders, including research and development, manufacturing, quality assurance, regulatory affairs , and external partners, to ensure alignment and ... overall business objectives for launch preparedness and enhanced robustness, regulatory , and compliance requirements of the company.Provide executive leadership and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … (MAPA), Customer Engagement and Integrated Solutions, Commercial Excellence, Legal, Regulatory Affairs , Compliance and other relevant NNI departments to ... between thought leaders and internal stakeholders, encompassing R&D, medical affairs , marketing, and market access teams, to drive innovation, scientific… more
- Twist BioScience (South San Francisco, CA)
- …and infrastructure teams, Manufacturing Operations, Quality Assurance, Process Development, and Regulatory Affairs teams to define MES requirements, design ... of our proprietary MES technologies will ensure strict adherence to regulatory requirements, optimize complex biological manufacturing processes, and align with our… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …market access and public affairs (MAPA), Centers of Excellence (COEs), regulatory affairs , other relevant NNI departments, and external stakeholders to ... success of HCP engagement strategies Health Systems Strategy o Collaborate with medical affairs and market access teams to inform and execute a health systems… 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 ... including development strategy, study design, initiation, execution, monitoring, analysis, regulatory reporting, and publication.Specifically, the Senior Director May Be… more
- Genmab (NJ)
- …Management, Clinical Operations, Medical, Biomarker Management, Biostatistics, Medical Writing, and Regulatory Affairs to ensure alignment of data strategy with ... protocol deviations and is a key driver for inspection readiness, regulatory compliance, and successful data submissions.The Associate Director will lead… more
- AUROBINDO (Dayton, OH)
- …with expertise in manufacturing, R&D, Quality Assurance and Quality control and regulatory affairs . In addition to several formulations under manufacture, we ... Level I shall assure compliance with all standards and regulatory guidelines.ResponsibilitiesCollaborates with other production/warehouse staff and other Departments.Accurately… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …other functional teams in NNI (including MAPA), including marketing, medical, R&D, regulatory affairs , finance, NNGlobal, and other relevant entities to develop ... brand portfolio strategy and maintain constant coordination brand leads. Essential Functions Integrated Portfolio Strategic Planning o Lead the development and operationalization of the Brand portfolio strategy for in line and pipeline portfolio assets… more
- AUROBINDO (Dayton, OH)
- …with expertise in manufacturing, R&D, Quality Assurance and Quality control and regulatory affairs . In addition to several formulations under manufacture, we ... have a robust pipeline of products. Aurolife's aim is to provide healthcare at economical prices to make this a healthier world to live in.Job Overview-1. Cleaning and organizing the Laboratory Glassware 2. Remove of liquid and solid waste from the containers… more
- AUROBINDO (Durham, NC)
- …team with expertise in Manufacturing, R&D, Quality Assurance, Quality Control and Regulatory Affairs . In addition to several formulations in our product ... and investigations under the direction of a supervisor.Comply with all regulatory /in-house requirements (may include but not limited to safety, house keeping,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … affairs , market access and policy/advocacy (MAPA), Centers of Excellence (COEs), regulatory affairs , and other relevant NNI departments to ensure alignment ... priorities Proven knowledge of the pharmaceutical industry, including medical, regulatory , clinical processes and market dynamics, especially within identified… more
- AUROBINDO (Durham, NC)
- …team with expertise in manufacturing, R&D, Quality Assurance, Quality control, and regulatory affairs . In addition to several formulations under manufacture, we ... with corporate and data protection standards.Support internal and external regulatory inspection activities related tovalidated systems.Provide support to Quality… more
Related Job Searches:
Associate Director RA Global,
Director-ra Global Regulatory,
Nsip Post Bach RA,
Nsip Post Bachelors RA,
Post-doctorate RA Dynamic,
RA Resident Assistant,
RA Resident Assistant Caregiver,
Reasonable Accommodation RA Coordinator,
Resident Assistant RA Training,
Senior Manager RA Global