- Daiichi Sankyo, Inc. (Bernards, NJ)
- …well as other research areas centered around rare diseases and immune disordersJob Summary: The Regulatory Process Manager will be a key member of the Global ... (GRA) Process Excellence & Analytics function, responsible for ensuring Daiichi Sankyo's Regulatory processes & procedural documentation are fit for purpose and… more
- Merck & Co. (Durham, NC)
- …day shift ( 6:00 AM - 6:30 PM ) rotation (2-2-3). - The role of Operations Manager at our Company's Durham facility is a manufacturing leadership role. The ... the team ( eg documentation , housekeeping, area 5S, etc.) - Participate in safety/ regulatory audits ( ie tours, topic discussion) - - Financial - Coach the team… more
- Aequor (Swiftwater, MN)
- …Information Management System [LIMS] Business Administrator is essential to Quality Operations at the Swiftwater site for supporting the maintenance and improvement ... products, updating master data for new and existing analysis, maintaining system documentation , and providing ad hoc support to other departments. The position is… more
- Merck & Co. (Rahway, NJ)
- …the operational/executional arms within the business. The Program Clinical Supplies Project Manager (Program CSPM) serves as the primary program-level GCS point of ... (as a lead GCS Planning program representative) such as clinical development, regulatory , quality and other supply chain areas to negotiate timelines,- strategies… more
- Eisai, Inc (Exton, PA)
- …management that the controls they have implemented are being executed.The Senior Manager is responsible for providing guidance on GxP and validation process ... improvements to increase efficiency and effectiveness and reduce cycle times and documentation overhead while maintaining the intended level of controls. The Senior … more
- Merck & Co. (Rahway, NJ)
- …within the business. Working independently, the Protocol Clinical Supplies Project Manager (Protocol CSPM) designs strategic and operational plans for all activities ... clinical supplies.-Interacts with key partner organizations such as clinical development, regulatory , quality and other supply chain areas to address clinical supply… more
- Novo Nordisk Inc. (Boulder, CO)
- …support analytical and process development, the CMC team works alongside Quality, Regulatory , Technical Operations and RNAi Early Development professionals at ... the Department The Boulder Site is home to the specialized technical operations /CMC team for oligonucleotides and RNAi therapeutics, continuing its legacy as the… more
- Merck & Co. (Durham, NC)
- …corrective actions to prevent re-occurrence and help assess the impact on operations . The incumbent will also be responsible for leading plant engineering's ... procedures, engineering design guidelines and business plan; receives guidance from manager when necessary.Provides & Implements technical guidance to given tasks,… more
- Merck & Co. (Durham, NC)
- …review, market restrictions review, and CBER submissions.Create batch specific documentation such as Health Authority monitoring reports or release-specific shipping ... as release SME (Subject Matter Expert) to support internal and regulatory audits.Support and lead department related initiatives associated with KPIs (Key… more
- Merck & Co. (Durham, NC)
- …HVAC, and/or multi-stage refrigeration systems. Experience and Familiarity of regulatory requirements in accordance with GMP manufacturing operations . ... and preventative maintenance (PM's) plans, as requested. Responsible for written documentation of activities. Responsible for SAP transactions and change control… more
- Merck & Co. (Durham, NC)
- …the Associate Director of Maintenance and Engineering or the shift Maintenance Manager , the Maintenance Specialist primary responsibility will be to help facilitate ... day to day Maintenance and Metrology operations in support of DS4 manufacturing operations .This...Maintenance Specialist has the opportunity to develop into a manager with a rapidly growing pharmaceutical manufacturerThis position is… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …System while collaborating with the Engineering team to provide necessary documentation , quality system interaction, and performing a variety of highly diverse ... West Lebanon, NH bioproduction facility. Relationships Reports to: Automation Manager Number of subordinates with direct/indirect referral: None Essential Functions… more
- System One (Florham Park, NJ)
- Job Title: Manager , Regulatory Operations Documentation Specialist - Contractor Location: Florham Park, New Jersey - hybrid 50% Type: Contract ... Compensation: $65 - $85 hourly Overview This role will lead the Regulatory Operations - Documentation Specialist team in overseeing the documentation … more
- Lilly (Philadelphia, PA)
- …functional areas. The Associate / Manager is responsible for CMC regulatory operations , CMC change management, and document lifecycle management within IMP ... for people around the world. Responsibilities: The Associate / Manager , CMC Regulatory and IMP Manufacturing Operations is a hybrid role within CMC… more
- Abbott (Alameda, CA)
- …with our new sensing technology. **The Opportunity** This ** Regulatory Affairs Manager - International Compliance Operations ** will work on-site at our ... their glucose levels with our new sensing technology. This ** Regulatory Affairs Manager - International Compliance Operations ** will provide support for the … more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …as other research areas centered around rare diseases and immune disorders **Job Summary:** The Regulatory Process Manager will be a key member of the Global ... (GRA) Process Excellence & Analytics function, responsible for ensuring Daiichi Sankyo's Regulatory processes & procedural documentation are fit for purpose and… more
- GE Vernova (Wilmington, NC)
- **Job Description Summary** The US Licensing Manager , Regulatory Affairs, will lead a licensing team and manage the completion of various regulatory work ... teams on major projects. **Job Description** **Essential Responsibilities:** As the US Licensing Manager , Regulatory Affairs, you will: + Manage the licensing of… more
- Abbott (Plymouth, MN)
- …location for our Electrophysiology division. As a manager , the function of a Manager Regulatory Affairs is to combine knowledge of scientific, regulatory ... and get on with their lives. **The Opportunity** The Regulatory Affairs Manager will work on-site at...+ Assess the acceptability of quality, preclinical and clinical documentation for submission filing. Compile, prepare, review and submit… more
- Kelly Services (Valencia, CA)
- **Kelly(R) Science & Clinical is seeking a Regulatory Affairs Manager for a direct-hire position at a premier client.** + **Location:** Valencia & Burbank, CA ... Range:** $100,000 - $140,000 annually (Depending on Experience) **Position Overview:** As a ** Regulatory Affairs Manager ** , you will operate under the guidance… more
- Rise Baking Company (York, PA)
- …regulatory compliance team + Oversee the preparation, collection, and coordination of regulatory documentation for submission to regulatory agencies or to ... to company policies and procedures. Essential Functions + Oversee the daily operations of the regulatory compliance department including managing direct reports,… more
