Rajeev John Email & Phone Number

New York, NY, US

New York, US

Manage the Rapid Filing Team processes and procedures for CTD to CTR conversion by year end 2024.Responsibilities include Work closely with the Rapid Filing Team (RFT) and act as the liaison between members of submissions and other functional areas in order to ensure timely submission of regulatory- compliant, quality documents. Interpret, implement, and.

Responsibilites included to be able to help designate specific documents to where they need to go and ensure a smooth process. Hit the ground running and work with multiple parties to drive submissions to completion. Responsible for setting meetings and deadlines for submissions. Help assist in the coordination of various submissions, while liaison with.

Tokyo, JP

Responsibilities included planning and tracking for CMC submission activities for the assigned product/project, ensuring appropriate stakeholder engagement and participation. Support operational excellence for CMC regulatory submissions by adhering to and applying established processes and tools. Day-to-day management of regulatory submissions, including.

Basking Ridge, NJ, US

Teaneck, New Jersey, US

Point of contact for client regional lead and for hub related queries. Working in close collaboration with the Head of Global Submission Publishing and Global Submission manager, assigned to respective franchise/activity with clear accountability for publishing process. Develop/adopt & implement best practices for producing & maintaining high quality.

Fort Washington, Pennsylvania, US

As a Global Regulatory Lead it is my responsibility to work with project teams, vertical team leads and other cross functional teams to seamlessly advance the acquired project through regulatory processes (submissions, reviews, agency response, and filing). Develop and implement regulatory strategy for assigned drug development candidates and/or marketed.

US

Responsible for managing and coordinating new archiving application vendors, QA document management, IT, and Eli Lilly. Responsible for managing the implementation activities, training, documenting new processes, and participation in software validation. Responsible for managing the Regulatory Archives (paper and electronic systems) by properly storing and.

New Brunswick, NJ, US

While at J&J I was responsible for all materials required in submissions, license renewal, and registrations. I fulfilled International Documentation requirements in support of commercializing US products in international markets. I prepared supporting documents and secure information required for Export Certificates (e.g. Certificate of Pharmaceutical.

Princeton, NJ, US

While at Sopherion I was responsible for managing the regulatory affairs program, dialogue and communication between clinical teams and regulatory department, working with the FDA on IND and NDA filing, ANDA filing (Health Canada), leading/attending strategy team meetings, preparing and reviewing regulatory filings as part of the maintenance of the IND.

Responsible for review, coordinating and submission of NDAs, INDs, CTD, CSRs, Annual Reports, Protocol Amendments, Clinical Study Reports. Responsible for coordinating responses to the FDA, setting up Type A, B, C, Ad Hoc review meetings. Coordinating with the publishing group to review record and confirm submission status of all submissions for different.

Review regulatory documentation required for the initiation of clinical trials for appropriateness, completeness, and compliance with regulations, compile regulatory submissions, e.g. INDs/CTAs and NDAs/MAAs, coordinate submissions to local health authorities, with oversight from management, coordinate regulatory submissions and contracts with vendors when.

US

include management of the Regulatory Affairs Associates, supervising support, track and review regulatory documents for accuracy and completeness. Communicate with sites/investigators on document status, updates and/or corrections. Liaise with Field Monitor on trial documents and start up activities. Work closely with Clinical Trial Leaders for informed.

Responsibilities included office management of the Clinical Trials Center, supervising support, administrative and clinical staff, and day to day operation of the center. Regulatory manager for all clinical trials being awarded to the center, document preparation, documents submission to sponsor and IRB, liaison for local and central IRB, Supervising.

Responsibilities included regulatory documents preparation and submission to sponsor and to Institutional Review Boards. Preparing study files and maintaining regulatory binder, preparing, updating and maintaining CV's of investigators, maintenance of Excel database of protocols. Remote data entry for online CRF's. Maintaining and updating research SOP's.

Responsibilities included regulatory documents preparation and submission to sponsor and to Institutional Review Boards. Preparing study files and maintaining regulatory binders, preparing, updating and maintaining CV's of investigators, maintenance of internal database of protocols. Screening patients for studies, randomizing subjects to trials.

Responsibilities included regulatory documents preparation and submission to sponsor and to Institutional Review Boards. Preparing study files and maintaining regulatory binders, preparing, updating and maintaining CV's of investigators, maintenance of internal database of protocols. Screening patients for studies, randomizing subjects to trials.

Bronx, NY, US

Responsibilities included scheduling patients, doing IRB submissions, maintaining patient files and updated protocol binders, Database input and correction, weekly reports on patient's status.

Bachelors In Applied Sciences, Applied Science

Public Health

Associate Degree; Aas, Computer Technology

High School Graduate, English, Math And Science