Michael L. Email & Phone Number

Chapel Hill, Nc, Us

Silver Spring, Maryland, Us

Princeton, New Jersey, Us

Prepared, reviewed, and submitted regulatory submissions (e.g,. ANDAs, supplements, PADERs) to the FDA in accordance with company timelines and FDA regulationsCompiled ANDAs and ANDA amendments in accordance with FDA ANDA checklist, FDA RTR guidance, and other applicable regulatory guidancePrepared supplements in accordance with FDA regulatory guidance and internal corporate standards to support various filings such as tech transfers, comparability protocols, and PAC-ATLS filingsCollaborated with senior management for the preparation of firm's first successful pre-ANDA meeting request for complex genericDisseminated information regarding significant changes associated with Federal Register notices, regulatory guidance, user fee legislation, exclusivity and patient legislationCoordinated with external vendors to obtain regulatory statements (e.g., residual solvent statements, TSE/BSE statements, melamine statements, cGMP certificates, debarment certificates, nitrosamine statements, DMF LoAs, US agent letters, technical datasheets, drawings) in support of filingsResponsible for the review of PADERs for content and compliance to FDA eCTD regulatory guidance prior to submission to FDACoordinated with external pharmacovigilance vendor for the submission of 15-Day Alert case reports to FDA and the preparation of PADERsResponsible for the review of spontaneous and literature-based 15-Day Alert case reports prior to submission by external pharmacovigilance vendorResponsible for notifying external pharmacovigilance vendor regarding product changes impacting PADERs and pharmacovigilance agreementsPrepared all regulatory filings (PV and non-PV) in accordance with FDA eCTD requirementsAttended project meetings as a representative of Regulatory AffairsExecuted regulatory approvals for document change controls

West Columbia, South Carolina, Us

Prepared and submitted product annual reports in eCTD format to USFDASubmitted controlled correspondence for bioequivalence assessmentAssisted in preparation and submission of CMC supplements for ANDA products in eCTD formatCompiled safety reporting sections (e.g., PADER) in periodic regulatory submissions to USFDA and conducted pharmacovigilance via literature reviewsCoordinated with Customer Service representatives to answer customer inquiries in addition to answering internal inquiries concerning products and regulations and Trained staff regarding Drug Safety regulations for drug manufacturers and 503B outsourcing facilitiesDeveloped and managed Drug Safety data and audit-ready files in response to third party requests and USFDA PADE and GMP inspectionsConducted follow-up, case processing, MedDRA coding, narrative writing, and submission of adverse drug event and medical device reports for products according to Food and Drug Administration requirementsDeveloped standard operating procedures to incorporate the electronic submission of individual case study reports (ICSRs) and Medical Device Reports (MDRs) to USFDA in compliance with ICH E2BConducted literature reviews for Pharmacovigilance in compliance with ICH E2DIdentified and disseminated information to senior members of management regarding competitors’ products and their respective regulatory strategies in therapeutic areas of interestDisseminated information regarding newly issued FDA and CMS regulations and rulesEvaluated competitors' SEC financial reports (e.g., 10-K, 10-Q), study reports, presentations, clinical study registries, and public intellectual property databases to evaluate and anticipate competitors' strategies in therapeutic markets of interestAssisted in the development and review of clinical protocols and Investigator Brochures for products under developmentManaged and successfully terminated multiple product recallsCompleted MDUFA registration for manufacturing facility

West Columbia, South Carolina, Us

Conducted the surveillance and investigation of complaints associated with medical devices in accordance with Food and Drug Administration Quality System RegulationAssisted in the development of firm’s Quality Manual and procedures governing the maintenance of Design History Files, Design Master Records, and Design History RecordsExecuted FDA MDUFA registration for GMP manufacturing facility

West Columbia, South Carolina, Us

Compiled safety reporting sections (e.g., PADER) in periodic regulatory submissions to FDA and conducted literature reviewCoordinated with Customer Service representatives to answer customer inquiries as a product expert in addition to answering internal inquiries concerning products and regulations and training staff regarding Drug Safety regulationsDeveloped and managed Pharmacovigilance data and audit-ready files in response to third party requests and FDA inspectionsConducted follow-up, case processing, MedDRA coding, signal detection, narrative writing, and submission of adverse drug event and medical device reports for products according to Food and Drug Administration requirementsCreated, managed, and closed CAPAs associated with Drug Safety operationsDeveloped standard operating procedures to incorporate the electronic submission of individual case study reports (ICSRs) and Medical Device Reports (MDRs) to FDA via the Safety Reporting Portal and Electronic Submission Gateway and trained company staff on PharmacovigilanceIdentified and disseminated information to senior members of management regarding competitors’ products and their respective regulatory strategies in therapeutic areas of interestEvaluated competitors' SEC financial reports (e.g., 10-K, 10-Q), study reports, presentations, clinical study registries, and public intellectual property databases to evaluate and anticipate competitors' strategies in therapeutic markets of interestDeveloped clinical protocols and Investigator Brochures for products associated with ophthalmic and respiratory indicationsMaintained permits and licenses for compliance with city, state, and federal agenciesCompleted MDUFA registration for manufacturing facilityPharmacy School Preceptor for South Carolina College of Pharmacy externs

West Columbia, South Carolina, Us

Designated as Project Manager for the implementation and validation of third-party software to create eCTD and CTD submissions and applications for regulatory submissionsPrepared multiple successful PIND premeeting requests and briefing packages for drug therapies Assisted with regulatory due diligence associated with potential product acquisitionsMaintained multiple facility permits for compliance with city, state, and federal agenciesPrepared eCTD regulatory submissions for processing in FDA Electronic Submission Gateway

Bentonville, Arkansas, Us

•Executed the intake of customer prescriptions, completed prescription orders, counseled patients on medications, and maintained the pharmacy inventory

Charlotte, North Carolina, Us

Doctor Of Pharmacy (Pharmd), Pharmacy

Bachelor'S Of Science, Chemistry