- Integra LifeSciences (Princeton, NJ)
- …and oversee quality and compliance improvement and remediation strategies for document and record control, change management , and training administration ... and set new standards of care. The Sr. Manager, Document Control and Training is responsible for leading the...and is the Enterprise Compliance Master Plan (ECMP) Quality Management System (QMS) team leader with responsibility to design,… more
- Parexel (Trenton, NJ)
- …+ Solid aptitude for use of IT systems; Regulatory Information Management System (RIMS), electronic document management system (EDMS), Proficiency ... the development of appropriate responses. * Participate in Safety Management Team (SMT) and Global Regulatory Team...manage the review and approval of labeling in a document management system. + Electronic document… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …Office programs (Word, Excel, PowerPoint, Outlook) and familiarity with electronic document management systems (EDMS). **Competencies** See OPDC Competencies ... strategy, planning and execution of global investigational and marketed prescription drug submissions and manages lifecycle regulatory activities in alignment… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …tools and systems needed for the function including and not limited to CREDO ( document management ), PRISM ( regulatory information management system), ... investigational filings, marketing applications (NDA/MAA), global submissions, and post-marketing lifecycle management as the CMC Regulatory lead. + … more
- Ascendis Pharma (Princeton, NJ)
- …The Regulatory Project Manager will be an integral part of Global Regulatory Affairs, providing project management leadership to key global regulatory ... ensure the delivery of business objectives. + Participate in Regulatory filing teams, providing project management expertise...minimum of 8 years of experience: 5 years in drug , biologic and/or combination products in Regulatory … more
- Sanofi Group (Morristown, NJ)
- …planning activities, including generating submission content plans, submission tracking, and document management utilizing the support and input of ... **Job Title:** Regulatory Strategist **Location** : Cambridge MA/ Morristown, NJ...of medicine? The race is on to speed up drug discovery and development to find answers for patients… more
- Sanofi Group (Morristown, NJ)
- …generating submission content plans, submission tracking, communication and document management + Contribute to internal regulatory processes and procedures ... to be used alone or in combination with a drug product, leading regulatory efforts in the...control deliverables. + Contribute to product development and lifecycle management planning. + Provide regulatory impact assessments… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …annual budget, and manage spend. + Author and conduct periodic review of regulatory intelligence management Standard Operating Procedures or work practices. + ... The Associate Director of Regulatory Intelligence leads the collection and dissemination of...platform. + Lead internal process to obtain, coordinate, and document cross-functional SME impact assessments of new or updated… more
- J&J Family of Companies (Raritan, NJ)
- …Function:** Discovery & Pre-Clinical/Clinical Development **Job Sub** **Function:** Regulatory Science **Job Category:** Scientific/Technology **All Job Posting ... & Johnson Innovative Medicine R&D is recruiting for an Associate Director, Global Regulatory Affairs Diagnostics. This position is a hybrid role and can be located… more
- Sumitomo Pharma (Trenton, NJ)
- …will be responsible for leading development of all non-clinical and clinical regulatory strategies including management of IND and NDA submissions, FDA ... activities; provide relevant input to Leadership + Oversee the regulatory activities at CROs, providing document review...experience in preparing strategies for and submitting applications for drug or biologic products (INDs, NDAs, MAAs) + NDA… more