- Eisai, Inc (Nutley, NJ)
- …Agility, Industry/ Regulatory Knowledge, Mentoring/ People Development, Project Management , Statistical Programming Skills, Vendor ManagementEisai Salary ... within related therapeutic areas. Programming experience from inception through submission in related areas.Senior Manager, Statistical Programming sought by Eisai… more
- Merck & Co. (Rahway, NJ)
- …or regulatory authorities.Prepares critical summaries and expert reports to management and/or for submission to regulatory agencies.Supervise trainees ... and procedures.Prepare the Final Study ReportMaintain contact with all stakeholders ( project leader, regulatory affairs, quality assurance etc.) and keeps… more
- Merck & Co. (Rahway, NJ)
- …reporting deliverables for R&D projects (data, analyses, tables, graphics, listings)Strong project management skills; leadership at a program level; determines ... position is a key collaborator with statistics and other project stakeholders in ensuring that project plans...of a programming team.US and/or worldwide drug or vaccine regulatory application submission experience at the leadership… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … Management Process for the respective business areas.Responsibilities:Leadership and Project Management :Lead the end-to-end quality execution across Medical ... status, escalating issues in a timely manner for earliest resolution, Regulatory Inspections:Facilitates regulatory inspection preparation, management , and… more
- Merck & Co. (Rahway, NJ)
- …(DBMS), Data Management , Data Modeling, Numerical Analysis, Outcomes Research, Project Management , Project Planning, SAS Macros, Software Development, ... and software development life-cycle (SDLC)US and/or worldwide drug or vaccine regulatory application submission experience including the development of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …that are compliant with applicable global regulatory guidelines. Collaborates wtih Regulatory Affairs to develop CDx submission strategies. May represent DS ... therapeutics. Responsibilities: Acts as CDx representative to the Global Project Team (GPT) for any projects that definitively require...trials or for approval of CDx. Keeps abreast of regulatory and policy updates in the external environment and… more
- System One (Tarrytown, NY)
- Regulatory Submission Project Management Specialist Location: Remote Term: 12-month renewable (CONTRACT TO HIRE) Target Pay: $30-$36/HR Must have recent ... PHARMA regulatory experience, preferably working on submissions. The Temp Regulatory Submission Project Management will provide support to the … more
- Sanofi Group (Morristown, NJ)
- …requested to lead GRT meetings. + Contributes to the development of the Global Regulatory Project Strategy (GRPS) and ensures alignment with the core product ... operational and compliance activities for assigned deliverables, develops, executes regulatory submission planning activities, including generating submission… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- … Affairs Specialist will work in BD - Specimen Management providing regulatory leadership to cross-functional project teams from early development to new ... the US and EU, as well as experience with project management activities. _Our people make all... guidance throughout the product development cycle prior to regulatory submission . + Identify and communicate appropriately… more
- embecta (Parsippany, NJ)
- …in a fast-paced environment. + Strong communication, negotiation, influence and project management skills. + Demonstrated cross-functional collaboration and ... management activities which include identification and interpretation of regulatory requirements, review and preparation of regulatory submissions required… more
- Organon & Co. (Jersey City, NJ)
- …the product lifecycle. + Lead development and execution of global product and project regulatory strategy(ies) by ensuring robust assessment of CMC changes, ... Identify, communicate and escalate potential regulatory issues to Organon Regulatory CMC management , as needed. **Required Education, Experience and Skills**… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- … regulatory guidance throughout the product development cycle prior to regulatory submission . + Identify and communicate appropriately quantified risks and ... and FDA guidance documents. + Strong critical thinking, communication, and project management skills. + Demonstrated global perspective, customer focus,… more
- Molina Healthcare (Yonkers, NY)
- **Job Description** **Job Summary** Establish a specifically designed Operational Regulatory Oversight program that effectively prevents and/or detects violation of ... regulations pertaining to the Health Care environment **Job Duties** The Operational/ Regulatory Oversight Sr. Analyst works with health plans and operations… more
- System One (Florham Park, NJ)
- … regulatory strategy experience in IND/NDA development, not just life cycle management . + Must have regulatory strategy experience in IND/NDA development, not ... just life cycle management . Overview Support the Regulatory Affairs (Executive...strategic documents for leadership discussions. + Maintaining and tracking project timelines, action items, and regulatory deliverables… more
- SMBC (New York, NY)
- …discipline to follow up on issues until resolved. + Must be well organized with project management skills. + Regulatory compliance experience at a broker ... and responses to regulatory inquiries and managing regulatory exams. + Support the preparation and submission...attributes. + Must be well organized with prioritization and project management skills on a global scale.… more
- SMBC (New York, NY)
- …examination management , project management , and relationship management skills supporting examinations and regulatory projects. + Attention to detail ... the primary Regulatory Relations liaison for high priority engagements including management of complex regulatory examinations and inquiries. + Advise and… more
- Actalent (Parsippany Troy Hills, NJ)
- …to team processes and CMC- regulatory related processes. Essential Skills + Regulatory submission experience with FDA and CMC. + Strong technical writing ... Job Title: CMC Regulatory Affairs Scientist Job Description As a CMC...growing the product portfolio and ensuring effective life cycle management . Responsibilities + Lead or oversee the development of… more
- Mount Sinai Health System (New York, NY)
- …and NYS regulations preferred. Prior leadership roles important, as is experience managing project groups. Non-Bargaining Unit, 620 - HSO Regulatory Compliance - ... provided. + Assists with the operational aspects of survey management , before, during and after the survey. This includes...with the respective accountable parties, ensures timely and complete submission of all regulatory reports to external… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- …addition, the position acts as a trusted advisor to senior management regarding Regulatory strategies/processes while developing organizational objectives and, ... submissions. + Lead and advise the planning, preparation and submission of all regulatory documentation. + Active...+ Leads and manages liaisons and/or provides direction to regulatory representatives and project teams who partner… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …Resource Management + Change, Communications and Engagement + Performance Management + Regulatory Inspection and Standards Excellence (RISE) Management ... life cycle, including roles, systems, and processes. + Familiarity with global regulatory frameworks and submission processes (eg, NDAs, MAAs). + Proficiency… more
