- Eisai, Inc (Nutley, NJ)
- …dossiers, supplements, amendments, as well as providing strategic product direction to project teams on interacting and negotiating with regulatory agencies in ... and answers any questions. This includes oversight, guidance, and management of GRS teams responsible for large, late stage... of existing products. May serve as the lead regulatory representative on the project team throughout… more
- Formation Bio (New York, NY)
- …and that messaging is consistent throughout all technical documentation to reflect the project and regulatory strategies and requirements. Reviews work of other ... clinical summaries and overviews, and clinical study reports (CSRs); regulatory documents (meeting and briefing packages, regulatory ...in moving any of these documents to completion. Keeps management current on project status and provides… more
- Eisai, Inc (Nutley, NJ)
- …Agility, Industry/ Regulatory Knowledge, Mentoring/ People Development, Project Management , Statistical Programming Skills, Vendor ManagementEisai Salary ... and drug development plans within the clinical development. Works with the clinical, project management , and data manager teams on strategic designs of studies;… more
- System One (Tarrytown, NY)
- Job Title: Regulatory Submission Project Management Specialist Location: 100% remote Type: Contract (9-month renewable) Compensation: $30-36/hour ... (dependent on experience) Overview: Provide support to the Regulatory Submission Management (Reg SM) group by working on routine regulatory submissions,… more
- BGB Group (New York, NY)
- …for consistent client submission success. Working closely with the Account, Project Management , Editorial, Medical, and Creative teams, they will ensure all ... as well as agency standard operating procedures + Collaborate with the account, project management , editorial, medical, and copy teams to prepare and submit… more
- Sanofi Group (Morristown, NJ)
- …and compliance activities for assigned deliverables, develops, executes + regulatory submission planning activities, including generating submission ... vaccine candidates in his/her remit + The RS leads submission team or regulatory sub team to ensure regulatory filings meet the project timelines + The… more
- Sanofi Group (Morristown, NJ)
- … deliverables and develop regulatory submission planning, including submission tracking in the electronic document management system. + Accountable for ... the GRL. + Contribute to the development of Global Regulatory Project Strategy (GRPS) and ensure alignment...strategy possible and determine any necessary updates to the regulatory strategy. + Lead the IND/CTA submission … more
- Citigroup (New York, NY)
- …for unique and demanding regulatory requests. The position will require project management and stakeholder engagement to ensure that regulatory ... & Technology, and CBNA Chief Risk Officer organizations. + Coordination activities include project management of exams, oversight and review of risk materials… more
- Bayer (Whippany, NJ)
- …+ Very strong knowledge of the drug/device development process; + Exceptional project management skills, including attention to detail, with the ability ... a real difference, there's only one choice.** **Director US Regulatory Affairs Liaison** The Director US Regulatory ...with GRS to ensure US input in the Global Project Teams (GPT). + Oversees and develops submission… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …serve as Regional Lead or Global Regulatory Lead on cross-functional/cross-regional Regulatory Submission Teams and Project Strategy Teams. Provides ... will lead Regulatory Submissions Teams or other Regulatory Project Teams and represent Global TA...assigned products and markets. + Critically reviews documents for submission to regulatory authorities. + May have… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …or other programs. You will lead Regulatory Submissions Teams or other Regulatory Project Teams and represent Global TA Regulatory on cross-functional ... Affairs and may serve as Regional Lead or Global Regulatory Lead on cross-functional/cross-regional Regulatory Submission...have one or more direct reports. + Provides matrix management and leadership to project teams. +… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …or other programs. You will lead Regulatory Submissions Teams or other Regulatory Project Teams and represent Global TA Regulatory on cross-functional ... Affairs and may serve as Regional Lead or Global Regulatory Lead on cross-functional/cross-regional Regulatory Submission...have one or more direct reports. + Provides matrix management and leadership to project teams. +… more
- Citigroup (New York, NY)
- …for unique and demanding regulatory requests. The position will require project management and stakeholder engagement to ensure that regulatory ... of this role is to support the execution of regulatory interactions across Risk Management , to ensure...work independently as well as collaboratively + Experienced in project management with excellent organizational, follow-up and… more
- System One (Florham Park, NJ)
- …regulatory strategy experience in IND/NDA development, not just life cycle management . Overview Support the Regulatory Affairs (Executive Director) in ... reports, and strategic documents for leadership discussions. + Maintaining and tracking project timelines, action items, and regulatory deliverables to ensure… more
- Sanofi Group (Morristown, NJ)
- …global regulatory strategies and be responsible for formulating the Global Regulatory Project Strategy (GRPS), Global Submission Strategy, and core ... labeling in development as well as for life cycle management of products. + Responsible for proactively contributing to...+ Experience being accountable for developing and defending innovative regulatory strategies at Global Project Teams or… more
- Citigroup (New York, NY)
- … matters and enhance the control environment. + Partner with Business/Function Regulatory Management Teams to share best practices, identify themes and ... risk management projects at a complex financial institution. + Excellent project management and organizational skills and capability to handle multiple… 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
- Mount Sinai Health System (New York, NY)
- …least 2 years managing investigator-initiated trials preferred. + Proven track record in regulatory compliance, project management , and team leadership. + ... healthcare industry experience required, preferably in the areas of project management , change management , health...(eg, FDA, IRB, ICH). + Oversee the preparation and submission of regulatory documents, including protocols, amendments,… more
- City of New York (New York, NY)
- …array of Sponsor Agencies, across the five boroughs. The current Design-Build Unit project management team both manages projects directly and supports the ... the Project Manager will be responsible for project management , resource development, and problem solving...and Sponsor Agency. - Provide oversight on site safety, regulatory compliance, and daily reporting and ensure compliance. -… more
