Experience

Chembio Diagnostic Systems, Inc.

• Senior Director

  • Oct 2020 - Present

• Director of Research and Development, Regulatory Affairs

  • Aug 2013 - Oct 2020

  •Oversee the submission/approval process with international regulatory bodies.•Author submissions, filings, registrations and other regulatory documents (including but not limited to: clinical/nonclinical documents, Technical Files/Design Dossiers) to obtain approval to bring new or modified products to market.•Maintain, review and manage various regulatory filings/registrations associated with maintenance of products in clinical research, approved / cleared / registered products in commercial distribution.•Manage and maintain global regulatory filing schedules. •Lead the development of competitive regulatory strategies for early-late-development and commercial projects in order to shorten development time and obtain the most favorable outcome. •Leverage experience in Regulatory Affairs to provide guidance to colleagues on regulatory requirements as it relates to studies and design expectations to ensure high-quality filings and successful registration within established timelines.•Assist in the Design/or design of study protocols and summary of executed studies to meet various registration requirements •Assist in feasibility and pilot tests and development of non-clinical, pre-clinical protocols as needed. •Interface with Quality and Operations as projects move from early development towards verification and validation. •Review Technical Study and Validation Study protocol / reports for compliance issues•Review change control process as it pertains to reportable changes to registrations to foreign governments •Review labeling and promotional materials for compliance; recommend appropriate changes•Contract and work with outside consultants in various countries to understand the regulations and to ensure regulatory compliance or other regulatory issues with foreign regulatory bodies. Show less



Consulting Private, 1- 10 employees

• Free Lance Scientific and Medical Writer

  • Jan 2011 - Present

  I have written numerous clinical documents for submission to regulatory authorities, including but not limited to: briefing documents, clinical development plans, previous human experience summaries, human pharmacology summaries, investigator brochures, study protocols, model informed consents, interim and final clinical study reports, common technical document (CTD) clinical overviews and summaries, safety update/aggregate reports, integrated summaries of safety and efficacy.I am also very adept at performing literature searches/reviews as necessary to obtain background information and training for development of documents. Show less



Mitsubishi Tanabe Pharma Development America

• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Senior Manager Regulatory Operations

  • May 2013 - Aug 2013

  • Manage the Regulatory Operations group of specialists and coordinators and contractors when needed. Allocate resources to support projects • Prepare (compile, organize, assemble and transcribe) and submit documents to the FDA (IND and NDA) • Manage the publication and timelines of regulatory submissions for the department and ensure all submission documentation is archived in controlled systems • Manage the Regulatory Operations group of specialists and coordinators and contractors when needed. Allocate resources to support projects • Prepare (compile, organize, assemble and transcribe) and submit documents to the FDA (IND and NDA) • Manage the publication and timelines of regulatory submissions for the department and ensure all submission documentation is archived in controlled systems



BD Diagnostics

• Bangladesh
• Medical and Diagnostic Laboratories
• 1 - 100 Employee

• Staff Regulatory Affiars Specialist

  • Dec 2012 - Apr 2013

  • Work independently to develop regulatory strategies for moderately to highly complex submissions to FDA and other regulatory agencies. • Prepare and coordinate the preparation of Pre-IDE, PMA, De Novo Petition, and 510(k) submissions. • Provide risk assessments of strategies and regulatory options to business teams and to product development/support teams. • Provide regulatory guidance, training and support to staff, and project teams. • Interact/communicate with regulatory agencies regarding company submission. Show less

• Regulatory Affairs Manager

  • Nov 2006 - Nov 2012

  •Prepare company submissions (PMA, IDE, 510K, 30-Day Notices, 135 PMA Supplements, Outlines of Production, etc.) to regulatory authorities, both foreign (European Commission) and domestic (including but not limited to FDA, CDRH, CBER, OIVD, and USDA) including paper and electronic formats. •Have obtained CE Mark for company manufactured products. •Liaison between company and outside regulatory and non-regulatory agencies (the CDC, for example) •Act as Clinical Trial Manager (with required travel of up to 35%). Duties include: Creation and development of clinical trial documentation such as clinical study protocols, clinical study reports, patient informed consent forms, investigator brochures, investigator agreements and summary documents; Project planning and implementation; Site selection and managemen; Assuring protocol compliance ;Data management ;Investigative site training •Prepare product labels and inserts in accordance with the FDA's labeling requirements. •Manage Departments’ medical writing activities. •Provide regulatory guidance, training and support to staff, and project teams. •Participate in appropriate timeline development, internal strategy, and operations or regulatory meetings. •Assist R&D with all aspects of new and existing product design and development, including but not limited to, basic experimental research and the exploitation of discoveries. •Develop and maintain documented regulatory procedures including the creation of databases and paper records as required assuring consistent and compliant regulatory activities. •Evaluate incoming complaint reports on real and/or perceived issues via phone/ written reports. •Responsible for investigating/resolving customer complaints and the determination if the submission of a Medical Device Report (MDR) is required. •Participate in both internal and external USDA/FDA/ISO/GMP audits and inspections. Show less