Accomplished, self-motivated, and teamwork oriented Regulatory Affairs and Clinical Research Professional with an accumulated 7 plus years of Pharmaceutical and Biotechnology industry experience. Expertise in regulatory submissions to the FDA in eCTD format. Working experience in Regulatory Affairs, Regulatory Operations, Clinical Research & Development, and Quality Assurance developing small molecule drugs, large molecule biologic products and combination biologic/device products.
Regulatory eCTD Project Manager
B & H Consulting Services, Inc. (A VCLS Company)
Coordinated and wrote IND Annual Reports from source documentation provided by client’s functional areas. Reviewed report content for clarity of regulatory reporting to the US FDA.
Provide electronic submission (eCTD) support related to regulatory submissions, including but not limited to: assess eCTD compliance of incoming documents, optimizing documents, book marking and hypertext linking, publishing document using docuBridge, QC of published xml output.
Manage/lead eCTD publishing to ensure compliance with regulatory standards and requirements.
Manage operational activities related to global pharmaceutical company’s Annual Report Project; including the preparation of FDA forms and cover letter, conducting final release of the annual report, tracking of submissions and management of submission schedules and compliance.
Dec 2015Jun 2016
Clinical Regulatory Specialist
Aerotek Scientific (contracted to Five Eleven Pharma)
Provided consultancy services for start-up radiopharmaceutical company.
Advised on regulatory submission requirements for early Phase I clinical trials.
Coordinated source document information from the local clinical study site to write and prepare the clinical trial protocol, consent form and case report forms.
Led 2 exploratory (non-commercial) IND applications to obtain approval for medical imaging trials in collaboration with the University of Pennsylvania,.
Advised the Chief Operations Officer with FDA interactions from the Regulatory Project Manager and the FDA review team.
Jun 2013Aug 2015
Senior Associate, Regulatory Affairs
Recognized by Regulatory Affairs leaders for going above and beyond to help the team meet their submission deadlines. Management of the content and quality review of electronic submission of IND and NDA lifecycle management submissions, such as Annual Reports, Safety Reports, CMC Amendments. Expertise at reviewing Clinical Submissions, such as New Protocol, New Investigator and Protocol Amendment type submissions in electronic submission format. Manage multiple regulatory submission projects for multiple clients while meeting or exceeding submission deadlines. Review of eCTD backbone file structure using eCTD Viewer to make sure the documents are in the correct location and are ready to be viewed by regulatory agencies.
Apr 2008Jul 2009
Patient Informed Consent Specialist
Authored, reviewed and submitted informed consent forms (ICF, Assent, HIPPA) for Vaccine and Infectious Disease Trials.
Provided crucial input to multi-functional clinical trial teams with IRB submission and GCP requirements.
Improved recruitment numbers for a stagnant trial for HIV and won award for guidance provided to a Patient Recruitment Specialist reference promotional material submitted to the central IRB review Board.
Nov 2007Jan 2008
Analyzed client clinical trial goals providing expert accelerated regulatory approval pathways. Persuaded clientèle to migrate from paper trial master files to an eTMF Documentum based storage saving the need to store paper in an archive room. Tracked trial progress in anticipation of planned start and completion dates to ensure client objectives were met. Coordinated, prepared and reviewed investigator documentation for submission to central Investigational Review Boards and regulatory binders for local site investigators.
Apr 2006Aug 2007
Document Control Specialist
Researched, presented and helped to implement an EDMS software program for both electronic and paper document control system which created inspection readiness and reduced change control timeliness. Advised senior management of documentation issues and provided practical solutions to remain in compliance with cGMP regulations and Good Document Practices guidelines. Reviewed Manufacturing and Quality Assurance documents such as Standard Operating Procedures, Quality Control specifications, test methods, protocols and batch records for format and compliance to internal company standards and external documentation guidelines. Received an annual bonus due to exceptional performance and dedication in meeting company objectives and departmental expectations.
Jan 2006Apr 2006
Regulatory Document Associate
Aerotek (contracted to Cephalon - West Chester)
Utilized electronic document control software (EDMS) to create, format and review documentation to meet 21 CFP Part 11 compliance (Super User)
Delivered software walkthroughs to new users and resolved technical queries for existing.
Assisted the Regulatory Manager converting the operation from paper legacy to electronic format.
Jan 2005Mar 2006
Global Regulatory Archivist
Kelly Services (contract with Centocor, Inc.)
Member of Project team migrating paper global regulatory submission archive to an electronic information library streamlining all work associated with the data.
Scanned paper submissions and added electronic submissions to an eDOC repository utilizing Documentum.
Created an excel spreadsheet of past safety (Medwtach/CIOM) submissions to help formulate an electronic database.
Concentration in Regulatory Affairs
WEST CHESTER UNIVERSITY
Concentration in Business Management
Experienced at developing relationships with clients and building trust to give them professional advice.
Filing of Investigational New Drug applications to the US FDA. Experience with submitting to CDER and CBER divisions.
Electronic Document Management Software
End user of Documntym and Qumas DocCompliance software. Managed clinical trial documentation electronically using document storage software.