Ensure RIM system, tools and procedures align with the user needs. Problem shoot user queries encountered with system interface. Create & update procedures related to the RIM system and ensure training is assigned to system users. Support validation activities. Participate in regulatory strategic operations meetings. Participate in audits and inspections.

Assisted change owners through the change control process, facilitated Advisory Council meetings, assisted in trainings, reported metrics for support areas

Supported the maintenance of a Regulatory database for CMC, Supply Chain and Regulatory requirements for various types of submissions; the database collects and reports filing components needed for post-approval changes. Responsibilities included maintenance of the database, facilitation of data reviews and data analysis for harmonization across regions and global training of system updates. Activities are conducted with strong communication skills and collaboration with internal users of the database with cross-functional interface to ensure accuracy, completeness and consistency of the data

Change Control Coordinator / Specialist provided support to the Home Office QA Managers (approvers) with timely reviews of local and global electronic change controls throughout the review/ approval process (from initiation, evaluation, approval to execution/ implementation and closure). Performed reviews of change controls to confirm compliance with company procedures. Assisted the change owners with addressing questions about their change control as well as answering questions about the electronic change control system. Collaborated with Subject Matter Experts to ensure relevant information is captured in the change controls before changes are presented to change control review board members. Upon closure ensured all activities have been completed as intended and supporting documentation is attached to change controls. Also completed administrative duties such as generating metrics reports for various change control categories.

Supported the maintenance of a Regulatory database for CMC, Artwork/Labeling, Supply Chain and Regulatory requirements; the database collects and reports out filing components needed for post-approval changes. Responsibilities included maintenance of the database, facilitation of data reviews and data analyzes for harmonization across regions and global training of system updates. Activities were conducted with strong communication skills and collaboration with internal users of the database with cross-functional interface to ensure accuracy, completeness and consistency of the data.

Managed the review of changes that may have regulatory impact to development and marketed products within the US by assessing change controls and facilitating the communication of changes to the health authorities. Managed, reviewed, and assessed change controls as well as represented regulatory at the weekly Change Control Review Board (CCRB) meetings. Participated on teams in a collaboratively effort to complete regulatory documents (Annual Reports) containing scientific information for timely submission to health agencies ensuring accuracy, completeness and consistency.

Supported quality and compliance pertaining to the development, testing and production of different therapeutic antibodies through interactions with R&D, clinical, regulatory affairs, project management and senior management as well as third party contract sites. Ensured implementation and maintenance of quality systems through documentation review/ approval of SOP, cGMP master and executed batch records for bulk manufacturing and fill/finish, process and equipment validation report, internal & external deviations, CAPAs and external auditing (ASQ-CQA).

Manage Regulatory commitments in Trackwise, which were associated with change controls. Prepare regulatory documents containing scientific information for timely submission to health agencies ensuring accuracy, completeness and consistency.

Supported and enhanced compliance for various manufacturing and quality groups through timely review/approval of SOPs, Forms Master Batch Records, logbooks, and validation protocols/ reports with Good manufacturing Practices (GMPs)/ International Conference for Harmonisation (ICH) guidelines and company procedures.

Assured accuracy and compliance of biopharmaceutical Development documents align with regulatory guidelines to maintain a GMP environment.• Managed new and revised documentation from creation through the approval process.• Trained Quality team members to ensure familiarity with process updates.• Certified as an ISO 9000 auditor.

Managed the receipt and tracking of controlled substances as well as the DEA biennial inspection.• Completed the quarterly and yearly activities reportable report for submission to the DEA.• Performed a detailed review of controlled documents and completion of packaging room clearances.• Timely completion of label reconciliation, executed batch review and drug returns.• Successful reconciliation of controlled substances used on site.

Managed packaging rooms with 1-20 packaging technicans for labeling, blistering and bottle fill clinical drug order for various clients.• Operated Klockner blistering machine, Thermoform/Zed carding machines and Kalish bottle filling line.• Worked with open and blinded labels for labeling of clinical drug and cartons creating patient kits.• Trained packaging technicans onn updated SOPs applicable to their job function.

Worked in assisting the packaging room leader to complete packaging records in primary (creating blister strips, blister card and bottling) and secondary packaging areas (labeling clinical material and creating open or blinded patient kits) to be sent to clinical sites.