Andre Pearson Email & Phone Number

New York, Ny, Us

Philadelphia, Pa, Us

Summit, New Jersey, Us

Richmond, Va, Us

Rahway, New Jersey, Us

• Prepared and reviewed dossier-related source documentation, including technical transfer reports, protocols, drug product formulation development and process validation summary reports, and other study summary reports, Collaborated with authors of individual dossier sections and provided advice on content and strategy• Provided post-submission support in responding to CMC questions• Collaborated with authors to write source documents participated in regular teleconference CMC organization project team meetings• Coordinated with cross functional groups to compile source information to build dossier• Communicated with Drug Product Development management• Provided advice on content of information in different source documents• Performed technical and regulatory CMC review of source documents and SmPC (EU),• Worked regularly in Docspace and ERIS environment for periodic draft updates and revised draft documents• Participated in face-to-face or remote draft review meetings to discuss completed sections• Provided advice on content of information to be provided in the responses and updated sections• Assisted in the preparation of responses and updated sections• Provided advise on presentation of information and the level of technical details to provide in responses and updated sections

Princeton, Nj, Us

Provided Regulatory CMC strategies.Authored, compiled, and reviewed CMC submissions in support of worldwide clinical and commercial applications for assigned products.Planned and provided written meeting requests and briefing packages for meetings with regulatory agencies and participated in the meetings.Collaborated with CMC functional groups to plan, write, and prepare high quality regulatory CMC sections of submission documents while meeting aggressive timelines.Ensured the appropriate CMC regulatory activities occur in support of the timely initiation of global Clinical Trials.Supporting the Regulatory CMC function in providing strategic and timely input to questions and issues raised by health authorities, as well as interactions with FDA throughout development phases and post approval meetings, teleconferences, briefing documents and contact reports.Interpretation and application of global CMC regulations and guidance to facilitate the development of products from clinical trials through to worldwide submission and approval.

Managed global programs with specific experience in post-approval CMC global regulatory submission.Provided and comprehensive understanding of CMC post approval guidance and regulation for global markets.Provided project management skills: handled diverse CMC projects and activities at different stages of criticality at any one time.Interpreted and communicated CMC Regulatory guidelines and present data in a clear and concise manner to key stake holders.Authored and create dossier content from source documentation as needed for registrations and provide writing support for technical reports.Created and author dossiers for re-registrations.Ensured all dossiers are in compliance with appropriate SOPs, guidance's, GXP and ICH guidance's and maintain up to date knowledge.Communicated with Quality and manufacturing site teams to request necessary content and documentation for regulatory submissions.Supported all aspect projects related to stability (chambers, qualification, calibrations, annual preventative maintenance, data review, report writing, graphs, data management).Provided quality standards, policies, procedures, and knowledge of current industry/regulatory standards for validation implementation, execution and completion.

• Experience in CMC(QbD), IND/NDA /ANDA/505(b)(2)/post marketing/ eCTD/documentation/submissions, pre marketing applications and subsequent amendments/supplements/CBEs. Stability report technical writing.• Products: MACI® (autologous cultured chondrocytes), Carticel® ((autologous cultured chondrocytes), CUBICIN® (daptomycin for injection), CB-315 (Phase III), Zuplenz® (Ondansetron), Suboxone® (Buprenorphine/Naloxone)

Provided regulatory leadership, oversight and strategy in support of product/portfolio assignments for products in the post-approval lifecycle.Managed a small number of individual contributors who are responsible for their own portfolio of products.Responsible for developing and overseeing implementation of regulatory strategies and making decisions that ensure the high quality of regulatory submissions.Assessed CMC post-approval changes to define regulatory requirements and develop CMC regulatory strategies that demonstrate sound regulatory insight, a balanced approach to risk and knowledge of the changing regulatory environment.Worked collaboratively with global stakeholders and peers, to align on priorities and support the achievement of product/portfolio goals.Supported project team goals and organizational initiatives, on an as needed basis. He/she will be expected to adequately represent the department needs and positions in senior leadership forums.Responsible for proactive and timely communication of challenges and opportunities to management and help address them in a systematic and thoughtful manner..

• Responsible for the development of regulatory submission documents including briefing documents and slide sets to support health authority meetings, answers to health authority queries, special protocol assessment/scientific advice requests, orphan designation applications, and clinical sections of BLAs for oncological products. • Responsible for managing a oncology clinical trial submission program which involved resolving inconsistencies between case report form data and the output of the clinical database, patient narratives, clinical study reports, current clinical trial status reports, and other administrative and clinical problems• Independently authored reviewed and revised regulatory documents, summary reports, and SOPs • Contributed to the medical/scientific input given for the development of trial-related documents and processes which reside in other line functions; obtain approval from internal review boards. Collaborate with the Medical Directors of (CPOs) and investigators to ensure their feedback is adequately integrated into protocol

Us

Responsible for managing analytical data, interpreting analytical data and creating preliminary stability reports.Analyzed trend stability data for drug substance and drug product.Evaluated stability data and created reports for submission to various authorities.Provided product stability reports and provided crucial product stability information to upper management.Supported all aspect projects related to stability (chambers, qualification, calibrations, annual preventative maintenance, data review, report writing, graphs, data management).Managed stability records addressing completeness and accuracy (location, inventory, and operation of the Stability Chambers, sampling of stability samples, human errors reporting.Reviewed and revised of reports, protocols, data, Standard Operating Procedures for Quality Assurance compliance.

Master Of Science (Msc), Chemistry

Bachelor Of Science (Bsc), Chemistry