Experience

eCTD Submit

• United States
• Biotechnology Research
• 1 - 100 Employee

• Vice President Regulatory Affairs

  • Dec 2015 - Present

  Co-founder and Vice President of Regulatory Affairs - began a successful career in regulatory affairs over 15 years ago; culminating in the key leadership role today. As an accomplished regulatory expert with a broad grasp of clinical, non-clinical and manufacturing requirements, I have worked for major pharmaceutical companies, CROs, medical device manufacturers and combination product companies. In addition to his extensive regulatory knowledge, I have had a long history of personal interactions with regulatory bodies such as the FDA, EMA, rapporteurs and notified bodies, including a broad experience of preparing for and passing regulatory audit. Show less



Ballston Consulting, LLC

• Managing Partner

  • Sep 2013 - Present



Delcath Systems

• United States
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Sr. Director, Regulatory Affairs

  • Jun 2010 - Oct 2013

  Provide regulatory affairs guidance and strategic input for the development, launch and post-approval maintenance of world-wide drug and device commercialization efforts for an innovative drug/medical device (Class III) combination product in the oncology market. Primary responsibilities include tactical and strategic knowledge of FDA, EU, OUS and ROW drug and device statutes, regulations and guidance. • Responsible for day to day regulatory liaison and regulatory operations functions for the company • Represent the company in interactions with global health authorities • Define regulatory strategy for clinical development programs • Design and implement regulatory strategies and regulatory project timelines that assure compliance with regional requirements as well as execution of desired business outcomes including product line extensions in support of device product development team efforts and provide guidance to those teams to ensure that development activities are consistent with overall regulatory strategy • Interact with clinical, nonclinical and CMC functions to ensure timely compilation and submission of all regulatory dossiers in the US, EU and ROW markets • Review and interpret technical and scientific data to ensure regulatory requirements are met; evaluate product/design and process changes for potential effect upon product safety and effectiveness; appropriately document regulatory disposition of such changes • Monitor, review and interpret new or revised regulatory requirements and proactively advise corporate disciplines. • Review and approve product labeling, including promotional Marketing literature/collaterals, to assure compliance with approved indications, internal procedures and applicable regional regulations. Show less



RANBAXY PHARMACEUTICALS, INC.

• Gloversville, NY

• Sr. Manager Regulatory Affairs

  • Jan 2010 - May 2010



AngioDynamics

• United States
• Medical Equipment Manufacturing
• 700 & Above Employee

• Manager, Regulatory Affairs

  • Jul 2008 - Dec 2009

  Primarily responsible for development and preparation of regulatory strategies and submissions aimed at achieving global marketing approvals/clearances and product licensure for new / modified products in the Surgery/Oncology Products business unit (minimally invasive surgical devices). • Authoring product marketing applications for the US (510(k)) and international markets including EU (CE Mark), Australia and Asia. Managing regulatory Agency interactions and communications (FDA and Notified Body). Worked with support groups to resolve significant issues raised by regulatory Agency’s which impact the submissions and prepared responses to review queries to ensure timely marketing clearances for assigned product line. • Preparation of Investigational Device Exemptions for clinical studies involving significant risk devices. Collaborated with Key Opinion Leaders in the Surgical Oncology field on appropriate clinical study design and authored investigational plans, clinical trial protocols, Informed Consent documents and CRFs. Managed recruitment activities for selection of clinical sites for study execution. Established Standard Operating Procedures for the Clinical Trial Quality Management System. • Review and approval of all sales, marketing, advertising and sales training materials to ensure compliance with cleared labeling and relevant FDA regulations and guidance. Show less



RANBAXY PHARMACEUTICALS, INC.

• Associate Director, Regulatory Affairs

  • Apr 2008 - Jul 2008

  Primarily responsible for development of regulatory strategy and project planning to achieve on-time submission of marketing applications (ANDAs and 505(b)(2) NDAs), amendments and supplements with the Food and Drug Administration with minimal turnaround time to approval for new and established products. Maintained registrations of existing products in compliance with applicable regulations. Collaborated with other business functions to ensure regulatory data requirements were met. Was the primary contact for FDA communications dealing with new product reviews and approval negotiations. Responsibilities also included planning and execution of activities related to third party alliance development of regulatory submissions. Supported other business functions including Marketing, Manufacturing, Business Development, and Quality Assurance (compliance). Show less

• Manager, Regulatory Affairs

  • Jan 2005 - Mar 2008

  Acted as the direct liaison with FDA Project Managers for assigned projects. Ensured the timely preparation of submissions including IND’s, NDA’s, ANDA’s and DMF’s (annual reports, supplements, and responses to FDA questions). Prepared and organized responses to regulatory Agency queries in a timely and efficient manner in order to obtain marketing approval. Provide guidance and training for newly hired personnel on subjects related to regulatory issues. Reviewed regulations, policies, guidance documents, USP revisions, issued by relevant regulatory authorities, which may impact the company. Show less



RANBAXY PHARMACEUTICALS, INC.

• Princeton, NJ

• Sr. Regulatory Affairs Associate

  • 2002 - 2004

  Key duties included: compilation, review and submission of INDs, ANDAs and 505 (b)(2) NDAs for assigned products. Review of submission related documents, including product labeling, CMC and BA/BE documentation to ensure information is complete, accurate and meets FDA regulations and guidance. Evaluation of deficiency letters and preparation of responses. Communication with Food and Drug Administration staff to assure timely approval of products. Identification of appropriate filing strategies and content requirements for post-approval variations and changes. Prepared pre-IND and pre-NDA meeting requests and briefing packages. Preparation of Annual Reports. Show less



Elan Pharmaceuticals

• Ireland
• Biotechnology
• 300 - 400 Employee

• Sr. Regulatory Affairs Associate

  • Feb 2001 - Jul 2002

  Key duties include: planning, organization and implementation of activities intended to register new products in the US and other global markets (Latin American, Middle Eastern and Asia-pacific regions). This included preparing/sourcing multidisciplinary information and assembling documentation related to IND and NDA filings and international dossiers; amendments/supplements to these applications and responses to regulatory Agency questions. Providing regulatory guidance to project teams and management. Interpretation and communication of changes in the pharmaceutical regulations as well as keeping abreast of US and non-US regulations in the pharmaceutical industry. Show less



TARGET RESEARCH ASSOCIATES, INC.

• Regulatory Affairs Associate

  • Apr 1999 - Feb 2001

  As an FDA liaison for domestic and foreign pharmaceutical/biotech clients, responsibilities included: Communication with clients and FDA personnel concerning new drug/device development strategy, regulatory requirements and compliance issues. Preparation and submission of regulatory applications to FDA, including Investigational New Drug Applications (INDs), New Drug Applications (NDAs), and Investigational Device Exemption Applications (IDEs). Also prepared pre-IND and pre-NDA meeting packages. Maintaining regulatory applications on file with FDA, which involved preparing responses to FDA questions, annual progress reports, information amendments, and supplements. Review of submission technical documentation for content, accuracy, and regulatory compliance. Coordinated all technical document-related activities, including document collection, format, pagination, assembly, and quality assurance. Show less



SCHIFF & COMPANY

• West Caldwell, NJ

• Regulatory Affairs Assistant

  • Mar 1998 - Mar 1999

  • Worked on various FDA regulatory submissions including 510(k) Pre-market Notifications and Pre-market Approval (PMA) Applications for Class III medical devices and in vitro diagnostics. Assisted with the preparation of an NDA and IDE. • Participated in third-party cGMP and GLP compliance audits of contract manufacturers, analytical laboratories, and drug manufacturers. Prepared the audit reports and consulted with the audited organization on implementation of corrective actions. • Developed concise documents in accordance with regulatory guidelines, which included study Protocols, Case Report Forms, and Informed Consent Documents. • Assisted with management and monitoring of clinical supplies to study sites. • Conducted on-site monitoring visits to insure strict compliance with GCP guidelines for Phase III Clinical Trials. Show less