- 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)
- …started? **Main Responsibilities** + Applies project management skills and regulatory knowledge for global submission types, from standard to complex. + ... , eCTD, and ICH. + Represents GRO Global Submissions Management on Global Regulatory Teams (GRTs) for...a cross-functionally perspective, supporting successful submissions. + Works within project teams in the control of submission … 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
- Pfizer (New York, NY)
- …medicinal and diagnostic products. Through your expertise, you will be the diagnostic regulatory liaison on the project team throughout the product lifecycle and ... a regulatory representative to marketing, commercialization, research project teams and government regulatory agencies. Your understanding of regulatory … 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
- 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
- Sanofi Group (Morristown, NJ)
- …able to manage multiple priorities in parallel. + Strong understanding of regulatory submission processes and health authority interactions. **Why Choose Us:** ... Coordinate end-to-end labeling processes, including governance review, internal alignment, and submission planning for regulatory dossiers. + Support … 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
- 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
- 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
- Sanofi Group (Morristown, NJ)
- …metadata specifications and project /study specific data requirements + Lead regulatory submission activities, including electronic submission packages + ... level activities + Provide guidance to junior staff on programming techniques, project management and implementation of standards + Collaborate effectively with… 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
- Glenmark Pharmaceuticals Inc., USA (Elmwood Park, NJ)
- …which includes Commercial Division Heads, R&D, QA, Legal, Business Development, Project Management , Demand Planning, Marketing and others identified on ... Associate Director, Regulatory Affairs Department: Regulatory Affairs Location:...responsible to communicate these updates to the identified Sr. Management on a timely basis including R&D for unapproved… more
- Sanofi Group (Morristown, NJ)
- …and dotted-line management toward all GPT members, including eg project management , clinical operations, regulatory , safety, translational medicine, ... GPT and Global Brand Team (GBT) + Defines global project plans and regulatory strategy together with...chain from research up to market access. Skilled in project and/or budget/resource management + Strategic thinking… more
- Veolia North America (Haworth, NJ)
- …and time management skills. + Proficiency in Microsoft Office Suite; experience with project management or permit tracking software is a plus. + Ability to ... & Regulatory Coordination + Coordinate and manage the preparation, submission , and tracking of permit applications required for capital construction projects… more
- City of New York (New York, NY)
- …Avenue, LIC, NY 11101 Only candidates who are permanent in the Construction Project Manager title or those who are reachable on the Open-Competitive List (Exam ... Design & Construction, Safety & Site Division, seeks a Project Manager. Under the general direction of the Chief,...Safety Plan (WPSP) applications from abatement contractors prior to submission to the New York City Department of Environmental… more
- System One (Newark, NJ)
- …Suite knowledge and the ability to work independently using the software. Project Management experience is required. RESPONSIBILITIES: + Coordinate with ... Project Scope document with all supporting documentation for submission . + Create project timeline include Initial...of a degree + Minimum 5 years of proven project management experience, including the design of… more
- Actalent (Hackensack, NJ)
- …center members. + Build research infrastructure to support multi-center clinical trials. + Perform project management for ad hoc projects as needed. + Adhere to ... Job Title: Project Manager, Clinical TrialsJob Description The Project Manager for Clinical Trials will manage multiple investigator-initiated clinical trials,… more