- Rose International (Tampa, FL)
- Only qualified Regulatory Program Manager candidates located near the Tampa, FL area to be considered due to the position requiring an onsite presence The ... Regulatory Program Manager is responsible for the management of technology projects within the regulatory program management team and support the governance… more
- Aequor (Thousand Oaks, CA)
- …mixed background not just lab but manufacturing and process development. This manager position within CMC will facilitate product development and global registration ... by developing and executing regulatory strategies and effective regulatory agency interactions for product manufacturing and quality programs throughout product… more
- BluPeak Credit Union (San Diego, CA)
- …ID: 2024-1709Type: Regular Full-Time# of Openings: 1Category: Risk ManagementCorporate OfficeOverviewThe Regulatory Enterprise Risk Manager plays a key role in ... programs are maintained to ensure the identification, assessment and control of regulatory compliance requirements, as well as operational risks inherent in all… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …required documents to FDA.RelationshipsThe fellow will report to the fellowship track manager within the Regulatory Affairs - Therapeutic Area team throughout ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the… more
- Russell Tobin & Associates (Columbus, OH)
- What are we looking for in our Transportation Project Manager ? PrideNow is seeking a Transportation Project Manager for an environmental, engineering, and ... to coordinate with Junior Engineers. As the Transportation Project Manager for the Great Lakes, this candidate will lead...on how our services can meet their needs Identify regulatory drivers for our services and build a plan… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Interactions: Leads US FDA/EU EMA interactions with support from higher-level manager . Regulatory Knowledge: Demonstrates expert knowledge of US/EU regulatory ... working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub team and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Centers of Excellence, Corporate Communications, etc.) Also interacts with Sales, Medical, Regulatory , and Legal. The Manager leads, manages, and directs a ... approval, distribution and lifecycle management of promotional marketing materials. The Manager will oversee the process across designated portions of the portfolio… more
- Windstream (Columbus, OH)
- …our customers Internet better (TM) every day. About the Role: As a Material Manager on the Kinetic engineering and OSP construction team you are responsible for the ... Commission, is required to notify and to obtain approval from federal regulatory agencies prior to granting certain system/network access to any non-U.S. citizen… more
- Lovelace Biomedical Research Institute (Albuquerque, NM)
- …GSA, Federal, HHS and DCA audits and prepare and file all necessary governmental regulatory reports and plans.The Manager will also oversee the daily operations ... Director of Research Administration and under limited direction, the Contracts Manager - Federal Contracts and Compliance, will oversee end-to-end contract… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Non-GxP activities, assuring that these systems are compliant with global regulatory and Daiichi Sankyo requirements, and business expectations. Executes the Global ... of system validation or qualification needed to achieve and maintain regulatory compliance regardless of service methodology (SaaS, On-Prem, Service Provider… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …adequate systems and process support, including facilitation of respective regulatory inspection preparation, management and follow-up in collaboration with impacted ... flow based on read outs from audits, inspections, Quality Events, regulatory intelligence, effectiveness checks on process implementations and metrics. Support… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for support and manage Quality Management System (QMS) in accordance with regulatory requirements and to ensure the adherence to the Quality Manual. Responsible ... adherence to the implementation of global and harmonized Quality Standards and regulatory requirements for GMP area. Responsible for the creation and review Quality… more
- Lundbeck (Sacramento, CA)
- …and transform lives. Join us on our journey of growth! As a Neuroscience Account Manager , this is an incredible opportunity to join the growing promotion of our CNS ... Environment/Compliance - Ability to apply knowledge of pharmaceutical and regulatory environment, including accountability and adherence to Lundbeck policies and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the timely release and delivery of pharmaceutical products as per applicable regulatory standards and company expectations for products. The incumbent is responsible ... Programs to assure product quality, integrity and compliance with regulatory guidelines and internal/global standards and procedures. Responsible for managing… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders. Summary: Manager , Sales Training and Development - Oncology serves as the training subject ... all projects and materials have been through the correct regulatory review process before being delivered to field sales...interaction with vendors and key senior stakeholders at Sr manager and director level in sales, sales training, and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …around rare diseases and immune disorders. Job Summary The Biosample Operations Manager , Biosample Management is responsible for supporting the oversight of the ... of bio-sample handling experience requiredWorking knowledge of ICH/GCP and regulatory guidelines/directives preferredWorking knowledge of CLIA/CAP regulations and GLP… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …systems to ensure they meet the needs of the business and regulatory requirements.- Collaborate with business units to identify opportunities for enhancing HCP ... and factoring regional needs, laws, and requirements.- Collaborate with the Project Manager (PM), HCP Engagement IT Operations team and business stakeholders to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. SummaryAs a Manager , Generative AI, you will be responsible for conceptualizing, developing, implementing, ... understanding of the drug discovery and development process, clinical trials, and regulatory requirements. TravelAbility to travel up to 5% Occasional travel for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as other research areas centered around rare diseases and immune disorders.Summary The Manager of Data Governance Stewardship will work in areas required for the ... with and understanding of key industry best practices as well as legislative, regulatory and industry artifacts / frameworks, such as, the following: o 21 CRF… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- Position Summary: Exela Pharma Sciences is seeking an experienced and dynamic Senior Manager , IS Quality to build and lead our IS Quality function. The ideal ... candidate will be responsible for ensuring compliance with regulatory requirements, industry best practices and internal standards as well as managing quality… more
