- Novo Nordisk Inc. (Plainsboro, NJ)
- …vendors. Internal stakeholders: Global Safety , QPPV office, Global Development, Product Supply, Regulatory Affairs (NNI/NNCI) marketing, legal and NNI ... at NNI and NNCI documenting compliance with corporate policies and local safety needs Product Quality: Oversees the implementation of procedures to ensure … 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 health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and external stakeholders. Coordinates project activities and needs related to Patient Safety . Ensures compliance with Federal regulations and company SOPs ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...reporting guidelines and Good Clinical Practice (GCP) to ensure adherence/ compliance Updates NAO Patient Safety SOPs and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …with stakeholder colleagues in Medical Affairs, Marketing, Legal, Marketing Operations, and Product Safety . Medical Education (option) Gain an understanding of ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...education and collecting data to support efficacy and new product development, CMR is involved. The one thing that… more
- Tris Pharma (Monmouth Junction, NJ)
- …and Drug Administration (FDA), cGMPs, Drug Enforcement Administration (DEA), Occupational Safety and Health Administration (OSHA), SOPs and regulatory rules, ... capabilities, when needed. The incumbent ensures timeline, quality and compliance with applicable Standard Operating Procedures (SOPs)/current Good Manufacturing… more
- Chemours (Trenton, NJ)
- …you will contribute to our business success by providing subject matter expertise on product compliance , safety , and sustainability. You will be tasked with ... a time. Chemours is seeking a **US Food Contact Regulatory Compliance Expert** to join our growing...new product development projects + Responding to regulatory compliance inquiries and performing periodic reviews… more
- FFP (Marlton, NJ)
- …The Regulatory Specialist is responsible for ensuring compliance with regulatory requirements in the areas of food safety , labeling, and product ... submit regulatory documentation, including ingredient listings, food safety plans, and product registration files. +...compliance . + Support the development and implementation of regulatory strategies for new product launches. +… more
- Ascendis Pharma (Princeton, NJ)
- …global strategies and local regulations . Coordinate US labeling activities for regulatory submissions, product maintenance and safety variations, including ... The RA Associate Director, Labeling will be overall responsible for ensuring compliance with US regulatory requirements for labeling, and for coordinating… more
- Takeda Pharmaceuticals (Trenton, NJ)
- …requirements and corporate policies, as well as work experience, to ensure regulatory compliance by assessing document requirements and identify information gaps ... to liaise effectively with cross-functional team members (Clinical, Global Patient Safety , Program Management, Global Regulatory , Regulatory Operations,… more
- Merck (North Wales, PA)
- …we are the right company for your long-term goals **Team Overview:** The Global Regulatory Affairs and Clinical Safety (GRACS) Regulatory Digital Health ... to the world by facilitating communications and procedures that allow swift, organized compliance across regulatory agencies. We are an international network on… more
- Church & Dwight Co., Inc. (Princeton, NJ)
- …with colleagues . Skills to work cohesively & constructively as a Global Product Safety Department. . Demonstrated ability to collaborate within and across ... the safety program strategy, influence the decision and alignment across Product Development, Marketing, Regulatory , Quality and Legal. The individual will… more
- Eurofins (Horsham, PA)
- …is dedicated to delivering testing services that contribute to the health and safety of society and the planet, and to its corporate responsibility to protect ... activities of the organization to obtain optimum quality & compliance of clinical operations and maximize profits by overseeing...to and retained by, the company. + Support all safety and corporate training programs. + Approve PTO schedules… more
- Merck (West Point, PA)
- …fabrication, FAT, SAT, Validation etc.) + Experience in regulatory compliance expectations across all phases of product development to commercialization. ... Duties & Responsibilities for the Director Include:** + Sterile drug product development concepts, tools, and technical/ operational/ regulatory requirements… more
- Bristol Myers Squibb (Princeton, NJ)
- …Act as the Safety Subject Matter Expert for input to regulatory product labeling. Participate/provide input at cross-functional labeling team meetings and ... Act as the Safety Subject Matter Expert for input to regulatory product labeling. Participate/provide input at cross-functional labeling team meetings and… more
- Sumitomo Pharma (Trenton, NJ)
- …Quality organization for audit and inspection preparedness and supports PVRM during regulatory inspections and audits. + Global safety planning and coordination ... Manager works closely with the Information Management (IM) and Safety Science groups as part of a matrix team...is considered confidential. ** Compliance ** :Achieve and maintain Compliance with all applicable regulatory , legal and… more
- BeiGene (Hopewell, NJ)
- …complaints, Batch Release Key processes and QA objectives, whilst adhering to regulatory compliance and achieving commercial success. Assists associates with ... NJ. Manages the operational performance of the Material and Product Release QA function, ensuring the successful day to... Release QA SOPs (writing, revising, and approving), ensuring regulatory compliance in conjunction with being 'fit… more
- Merck (West Point, PA)
- …and continuous improvement initiatives to guarantee the safety , effectiveness, and compliance of our company's product portfolio. The product steward ... internal quality and technical requirements are achieved, and ensure filings with regulatory bodies to ensure compliance with relevant regulations and standards,… more
- Syensqo (Princeton, NJ)
- …SDS authoring process or for issuing other regulatory documents + Support business and Product Safety members following the new ways of work in SAP EHS and ... network. This role will shape new business processes around regulatory compliance , and environmental sustainability data which...and regulatory documents. + Support business and product safety members with new SAP EHS… more
- Integra LifeSciences (Princeton, NJ)
- …of directors. + Support interactions with regulatory bodies and ensure compliance with all applicable quality and safety standards. Responsible for leading ... product development, process technology, operations, supply chain, procurement, regulatory affairs, finance, and human resources. + Develop organizational design… more
- Promotion In Motion (Somerset, NJ)
- …and safety . + Conduct design verification testing, reliability testing, and regulatory compliance testing to ensure that products meet quality standards and ... Product Development Engineer Job Details Job Location Somerset...develop innovative fruit snack formulations that meet consumer preferences, regulatory requirements, and production feasibility. DUTIES AND RESPONSIBILITIES +… more
