Greater Chicago Area
I love the feeling of helping others and trying to help others live their best life, which is how I got into pharmaceuticals and medical devices. I am very dedicated, hard working, detail oriented and enjoy a challenge. My favorite strengths are that I am not afraid to ask questions and I am part of the hard of hearing community. I am currently introducing myself to the RAPS community.
Prepares CMC regulatory post-approval submission structures and impacted documents for drafting and formatting, including response to questions and supporting annual reports for marketed products. Assists in formatting and uploading special documents into RIM system for an initial Marketing Authorization Application submission. Track statuses and coordinates multiple marketed products and their submissions with the Product Lead and any associated Subject Matter Experts, enabling flexible prioritization as needed. Offers regulatory guidance on how to present data and information to regulatory agencies, under the supervision of management, utilizing experience with multiple products. Stays updated on regulatory procedures and changes, and will address potential changes to processes when applicable.
Manage data on external FDA databases, ensuring compliance with regulations for GDUFA ANDA/Affiliate Count, GDUFA Self Identification, GDUFA Establishment Registration, and Product Recertification, leading to 100% on-time submissions and reducing compliance risk in CDER Direct and CDER NextGen portals. Oversee product data in internal Regulatory Tracking software, Samarind RMS RegTrack, archiving and tracking all correspondences and submissions to maintain accurate product profiles. Train counterparts in the US and India to serve as backups, ensuring the India team becomes self-sufficient in managing correspondence entries, with oversight to maintain accuracy through thorough reviews. Provide reports to CMC team members using internal Regulatory Tracking software. Track updates on FDA's IDMP implementation to ensure RegTrack compliance with regulatory requirements. Track and maintain the only comprehensive list of submitted drug listings, ghost listings, de-listings, and relevant NDC and establishment information utilizing Smartsheet, ensuring accuracy and regulatory compliance. Assist in developing, preparing, and maintaining Standard Operating Procedures (SOPs) and work instructions. Manage Microsoft Access Database by updating deficiency entries, categorizing data, and performing annual maintenance. Researched and implemented processes in response to the newly finalized CARES Act, attending FDA webinars to stay informed and ensure compliance with its regulations. Collaborated with SAP IT to gather distribution and release data for US sites; coordinated with non-US sites to populate and submit the FDA CARES Act template. Worked with SAP IT to generate a Business Analysis Report in Excel for Annual Reportable Distribution Data.
Supported the Regulatory and Compliance Manager in managing data on external FDA databases, ensuring the company’s compliance with GDUFA ANDA/Affiliate Count, GDUFA Self Identification, GDUFA Establishment Registration, and Product Recertification requirements. Served as a backup for managing product data in internal Regulatory Tracking software, archiving and tracking all correspondences and submissions for product profiles. Assisted in developing, preparing, and maintaining Standard Operating Procedures (SOPs) and work instructions. Created and implemented a Microsoft Access database for tracking deficiencies, enabling self-search functionality for the Regulatory department and generating metrics reports. Collaborated with the Regulatory and Compliance Manager to resolve a backlog of Reference Listed Drug (RLD) and safety-related changes with the Labeling team. Assisted the Regulatory and Compliance Manager in executing Corrective and Preventive Action (CAPA) tasks.
● IT POC contact for multiple site’s lab personnel and own individual site issues and action items on behalf of the global project team to deliver on time. ● Responsible for building repeatable standard work rollout data templates /job aides which are clear, concise, and easy to understand by multiple audiences, especially chemistry and micro lab personnel. ● Demonstrated knowledge of application functionality and serve as a key global LIMS system process expert. ● Identify and understand issues that may impact the site schedule and provide appropriate solutions. ● Effectively determine when to escalate open questions, issues, and risks to the Project Manager. ● Strong writing and communication skills, including hosting meetings for globally located sites. ● Provide continuous improvement input and enhance existing standard work templates. ● Bring creative solutions to solve business problems, looking beyond the obvious or typical approaches. ● Followed Baxter regulations and naming conventions for data in system while creating working templates as well as making direct changes in the Production environment. ● Team collaboration skills; effectively work with multiple cultures and working styles. ● Effectively worked in a large project structure with multiple projects as well as individually. ● Understand and follow appropriate system life cycle processes. ● Travelled to India to conduct onsite training of LIMS roles.
● Follows regulations and GMP practices in respect to lab records, procedures, and systems in accordance with procedural requirements as a QA analyst. ● Uses documentation skills of completeness, timeliness and Abbvie’s ALCOA method for writing out test procedures to be easily replicated, collecting, comparing and presenting results particularly in tracking and trending and regulatory filing while implementing Word and Excel to display data and results and verification of data and results to support final product/material release. ● Utilizes and understands laboratory techniques to test products using wet chemistry and chromatography to obtain consistent, accurate, and reproducible results in a timely matter. ● Implements technical proficiency, critical thinking skills and leadership by operating and trouble-shooting instruments which may require out of the box thinking, inputting feedback if another analyst has trouble and by determining action based on potential errors. ● Participated in project work while validating test method transfers from other sites or new pharmacopeia requirements and creating new methods and procedures for new products that can easily transfer to other sites while utilizing skills in communication cross functionally with other departments in a timely manner. ● Takes responsibility for completing and managing assigned work tasks and goals and can independently prioritize work schedule in order to meet both objectives. ● Participated in group project work in a development culture group. Helped set up information sessions for those interested in learning specific tools to help with development like navigating the job board and introductions to other departments, helped with putting a PowerPoint presentation together for departmental meetings and upper management and provided feedback to managers and peers on the importance of open communication.
• Used documentation skills of completeness, legibility, timeliness and accuracy to perform monthly inspections. • Followed regulations and procedures to ensure safety and preparedness of audit readiness. • Assisted the safety committee with issues that require management attention, like accidents and near misses reported from other locations. • Verbalize safety related work to committee members and serve as a communication link between the committee and managers, especially while preparing for the start of the departmental move from R1B to R14, discussing the importance of peroxide former testing and starting the process of obtaining secondary containers for waste containers to potentially avoid the risk of a spill due to overflow and specific attachments to waste containers for waste lines.
Contractor position.