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 ensure compliance with relevant revised and new FDA/ICH regulations to meet company deadlines. Have direct impact on the company's ability to meet goals and timelines related to CTD to CTR submissions; identify and escalate issues which may impact submission timelines and goals. Coordinate core documentation activities. Develop and maintain best practices for the Submissions Group consistent with evolving FDA guidelines for electronic submissions. Provide support to Regulatory Affairs, Clinical Operations and Reg. Strategy and other project stakeholders in the creation of submissions documents. Work collaboratively and efficiently with multiple functional areas in a fast-paced matrixed team environment, including functional team members, company management, and external vendors and contract organizations

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 other folks involved with the process. This will be at the senior manager level. Background in large molecule and oncology, eCTD. Experience with life cycle maintenance of applications.

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 preparation for and leading of meetings, document manipulation and routing for authoring and review, etc. Provide guidance for submission eCTD granularity and global CMC and other module submission requirements. Enable high quality documents through content review and compliance to submission ready standards. Develop and maintains strong communication and collaboration with the stakeholders. Be proficient on the EDMS system and provides support to end users to ensure effective utilization of document management systems.

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 deliverables. Liaising with a team of Publishers located globally. Working in a global capacity with colleagues across these regions. Providing strategic and operational expertise to teams for routine or maintenance submissions to ensure the timely, quality preparation and execution for electronic and paper submissions to Global Health Authorities (EU, US). Ensures country-specific regulatory requirements, as provided by client, are assimilated into teams and processes. Establishes new processes including documentation and perform QC work through spot checks, as needed. Create and maintain regulatory affairs documents like QCP, SWI as applicable for all aspects of Regulatory affair. Provide inputs as a SME to operations team as and when required. Monitor the quality of deliverables, identify potential risks and mitigate them in advance and raises concerns and issues to the Engagement Manager proactively. Ability to prioritize work and manage multiple projects and tasks. Interaction with stakeholders and client through emails, and telephonic conversations, maintenance of proper communication channels, ensuring updates are getting percolated in the team. To ensure timely deliverables & their adherence to SLA's by maintaining a tracking mechanism. Monitor the progress at all phases (i.e. from training, mocks & the live work) and ensure smooth operations. Facilitate weekly review meetings for progress, metrics, escalation, training, resourcing. Regular meetings with the client leads to understand the challenges/concern if any and be solution oriented in approach.

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 products. Interact with FDA and other international regulatory agencies globally on a proactive, independent and frequent basis. Communicate company views to regulators and maintain effective, professional relationships with regulatory agency officials. Provide direction for assigned programs by coordinating all aspects of regulatory submissions and responses and regulatory management of the products over all life-cycle. Represent regulatory affairs on internal and external project teams, provide advice to project teams and line departments on regulatory requirements guidelines and strategy. Work collaboratively with Regulatory Affairs colleagues in CMC and Operations, etc. to ensure integrated, well-coordinated approaches to planning regulatory submissions and responses and development solutions to regulatory issues. Manages the timely preparation and submission of INDs, NDAs and BLAs ( and corresponding international registration packages) amendments/supplements, variations to these applications and respond to regulatory agency questions.Manage client expectations on project enrollment and business continuity. Working with offshore delivery centers to ensure a high level of resource allocation for each assigned project. Meeting and developing a program plan with clients to enhance the project requirements and provide a high level of service for each project.

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 retrieving documents in a timely manner according to processes and procedures. Manages the archiving requests from other ImClone functions and provides advice to Regulatory Liaisons and Submissions Management to ensure consistent archiving and retrieval for health authority documents. Responsible for acting as the key liaison between Regulatory customers and the archive information database. Partners or directs customers to specific authoritative sources of information to satisfy specific information needs. Decision-maker for access to the collection of information of all media types and is a resource as a Subject Matter Expert for historical content of information processes. Process owner for the roles and responsibilities of the eArchive database. Oversees that all requests for archiving are completed and closed according to written procedures. Creates metrics reports and uses metric reports to identify trends and needs for training. Manages collaboration with Regulatory Liaisons to ensure that archive requests in support of audits are reviewed and provided to ImClone contacts prior to being sent to health authorities or internal/external inspectors and auditors. Addresses any escalated problems and facilitates any business decisions pertaining to conflict management and process management

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 Product, Certificate of Free Sale, etc.) and submitted to relevant health authority (FDA, Personal Care Products Council). I satisfied market specific information requirements by querying the systems (e.g. GSS, APR, Optiva, Connect, etc.) and contacting appropriate departments (e.g. Quality Assurance, R&D, Regulatory liaisons, etc.) Responsible to ensure that the correct formula is identified and attached to the certificate and consistent with the label. Perform quality control checks on each application. Communicate directly with the markets to clarify requests and set priorities. Champion assigned region and lead discussions/provide background information to facilitate. Provide data package to administrative support in a format ready for scanning and upload to CONNECT. Provide input into how the overall process can be improved and implement agreed recommendations

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 (e.g. Investigator documentation, Annual Reports, Type A, B meetings, Fast Track Applications, CMC documents). I researched, reviewed and recommended consultant companies for the NDA eCTD submission format. Ensured consistency, completeness, and adherence to FDA standards for all regulatory submissions. I managed the migration of paper regulatory documents and submissions into electronic format. Prepare and submit reports to senior management, as required. Maintain compliance with current Good Clinical Practices (GCPs), government regulations, industry standards, approved specifications, and Company procedures and directives. Ad hoc reviews of Clinical Research Organization (CRO) Investigator documentation and regulatory files reviews. Working with clinical and regulatory contractors, consultants and contingency workers in achieving desired objectives for the company. Managing regulatory specialists and contractors to ensure proper regulatory procedures are followed, filing timelines are adhered to and planning and scheduling IND, NDA routine submissions and flings, writing, reviewing SOP's for the company. Maintaining and updating Intralinks (Web Portal and documentation management repository) with documentation and access.

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 compounds and products in the Oncology, Internal Medicine and Neurology fields. Work in working groups to set up policy and procedures for e-CTD, e-NDA and e-IND submissions.

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 local submissions require a legal presence in a particular country in which Pharmanet has no offices, with oversight from management, coordinate the importation/exportation of clinical supplies and/or biological samples, archive regulatory documents (in both paper and electronic formats), conduct scanning and electronic publishing to support both regulatory submissions and other electronic publishing projects, conduct Quality Control reviews of regulatory documents, such as Clinical Study Reports, obtain translations as required or translate documents, if qualified, remain current with changing regulatory requirements to assure compliance with regulatory agency requirements, applicable ICH Guidelines, Good Clinical Practices, and Pharmanet SOPs.

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 consent/IRB approvals. Process regulatory documents and fully execute contracts to allow study start-up according to planned timelines. Coordinate central IRB submissions. Manage and track submission of documents to FDA and archive files prior to drug shipment. Interact with Safety to manage investigator alerts. Attend Investigator meetings to collect regulatory documents. Process study maintenance in a timely manner. Update database on an ongoing basis to reflect that documents have been received, reviewed and approved. Interviewing and training of new employees. Piloting the Intralinks Web Portal system for regulatory documents exchange between site, sponsor, Central IRB's and FDA. Working in Documentum to combine the documents collected via Intralinks and filing them for Central files.

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 HAZMET and HIPPA training for all coordinators at the center and at the hospital, working with contracted companies in setting up national and local advertising for trials. Managing and updating database of patients and studies for the entire network including other hospitals in the network. Preparation and updating of CVs and licenses for research investigators. Contact person for questions and issues with local and central IRB's.

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 for the department. Schedule tests and treatments required for protocol randomization. Maintain protocol patient database.

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, maintaining study files on patients, liaison for scheduling and setting up appointments for patients. Attend Investigator Meetings.

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, maintaining study files on patients, liaison for scheduling and setting up appointments for patients.

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