Pharmaceutical Regulatory Expert For - Sterile Injectables, Solid Dosages, and Inhalation Products Sectors

Expertise

• High-performing Regulatory Affairs and Compliance Professional with over 25 years of diverse pharmaceutical experience in sterile injectable, solid dosage, oral solution, and inhalation product environments.
• Demonstrated knowledge of regulations and the NDA/ANDA/DMF eCTD submission process with a successful track record in obtaining over 200 drug product approvals.
• Proven expertise in negotiating effectively with the U.S. FDA applying broad understanding and experience in handling pre-approval and CGMP inspections.
• Works with both entrepreneurial start-ups and large companies, supporting several foreign firms as the U.S. Agent to the FDA. Clients include some of the largest generic drug, branded and API manufacturing firms in the U.S., Canada, India, the United Kingdom.
• Implements successful remediation plans for manufacturing sites under import alert, warning letter status and has managed large-scale site certification activities.
• Provides significant contributions in the areas of Regulatory Sciences and Compliance with a proven ability to direct and oversee projects on a full life cycle scale, from early stage product development through to the FDA approval process and post approval marketing activities.
• Oversees management and review of regulatory submission projects and the implementation of quality project management systems and strategic plans to help strengthen filings and optimize approval times for clients. 
• Successful management of responses to FDA 483’s and warning letters for both finished dosage and drug substance manufacturers, and the implementation of corrective action plans are also key components of expertise.

Targeted Areas

• Regulatory Affairs
• Regulatory Compliance Strategy 
• ANDA/NDA Approvals 
• eCTD Operations 
• FDA Guidance/Federal Regulations  
• Product Life Cycle Management 
• Project Management 
• Auditing and Remediation
• Project Management
• Quality and Compliance
• FDA Applications-Amendments
• FDA PAI/GMP inspections
• U.S. Agent Services

Experience

A.T.L.R.C., Owner, 2011 - Present

• A company that applies a holistic approach in Regulatory Affairs, Project Management, Quality and Compliance support to achieve a positive outcome for your product approvals and ongoing facility compliance.  
• Project management oversight supports the timely submission of original applications to the FDA, amendments during the review stage, ongoing monitoring of the review status of each pending submission and assistance with site readiness for FDA PAI/GMP inspections with the end goal of obtaining timely approvals.
• The ATLRC team consists of contributing consultants who are experienced in a broad array of pharmaceutical support systems including all aspects of Regulatory Affairs, Compliance, GMP and Quality Systems auditing, SOP Development, Training and Remediation plans.

Client Solutions

• Obtaining drug product approvals applying sound regulatory strategy to FDA submissions resulting in quick, expedited results.
• Develop complete drug product applications forFDA review and amendments, providing a smooth process.

Onsite Compliance

• Developing strong quality systems within companies addressing the importance and requirements for the timely approval and continued marketing of drug products. 
• Multiple services executed to achieve and maintain ongoing site compliance.

Regulatory

• Develop sound regulatory strategy, acting as an active client partner in ensuring submissions are correctly prepared and filed to the FDA in a timely manner. 
• Using effective strategies and submission plans, provide regulatory support at every stage or alternatively, during specific segments of projects.  
• Maintain professional relationship with the FDA to guide client’s product through the approval process. 
• FDA follow up of each application discipline to ensure the applications moving through the approval process, with any review inquiries that are addressed quickly.
• Preparation, submission and management of regulatory filings to the FDA.  Assistance with addressing filing requirements from strategic advice on content to correct compilation of initial filings and post approval submission activities
• Electronic CTD filing services.
• Review of FDA correspondence and submissions for completeness and compliance with FDA regulations and guidelines.
• Implementation of strategic submission plans and project management systems to strengthen FDA regulatory filings.
• Development of systems and procedures to support the control of regulatory submissions on a pre and post approval scale.
• Development of effective strategies to optimize approval times.
• Assistance with Field Alert reporting.
• Guidance, review and preparation of regulatory process and compliance SOPs in areas such as CTD development, field alerts, adverse event reporting, recalls and post approval filings.
• Assistance with the development and review of product labeling, electronic labeling filings, and drug listing activities.
• Regulatory due diligence audits as part of product or company acquisitions. 
• Conduct effective regulatory assessments of approved products, applications pending approval, and evaluation of departmental regulatory control systems.

U.S. Agent Services

• As client liaison to the FDA, work effectively with firm to facilitate filings and information requests from the FDA to help avoid delays with product approvals.  
• Liaison with the FDA and clients to support timely approvals of submitted applications and help to navigate quickly through any developing issues.
• Provide support and guidance with focus to FDA administration regulations.
• Facilitation of client meetings with the FDA.
• Coordination of foreign facility inspections by the FDA.
• Filing of foreign establishments and registration updates as changes occur.

Quality-Compliance Services

• Maintain a GMP-compliant company profile.
• Assign highly qualified and experienced individuals from a network of industry experts to address compliance and quality projects.
• Ensure a steady state of compliance by consistently adhering to established procedures and standards is our goal.  
• Periodic audits by industry teams verifying site compliance, address issues before significant problems arise.

Quality System Development

• FDA-483, warning letter and consent decree remediation plans.
• On-site assistance during FDA inspections.
• Drug product recall support.
• Strategic planning for FDA facility approval.
• GMP and pre-approval inspection audits (FDA style “mock” inspections).
• CAPA management.
• SOP development.
• Training programs.
• Audits of third-party companies to support facility and product acquisition plans.

Project Management

• Project Managers provide support and oversight on a wide variety of project management plans for continuance in compliance and achieve product filing goals. 
• Apply knowledgeable experience and a unique skillset to execute projects effectively and
• efficiently, enabling project resulted business goals.
• Regulatory Affairs submission and strategy.
• Remediation plans.
• Quality system continuous improvement plans.
• Change Control Management.
• CAPA Plans.       

Sun Pharmaceutical Industries, Inc., Cranbury, NJ,  2006 - 2011

Director of Regulatory Affairs                

• Responsible for development, implementation and oversight of the Regulatory Affairs departments at U.S., facilities and the development of corporate strategies to optimize ANDA approval times. 
• U.S. Agent responsibilities for global finished product and API facilities.
• Established the U.S. Regulatory Affairs department and all required infrastructure.
• Designed and implemented strategic regulatory submission plans for generic products developed at U.S. locations and successfully implemented corrective action plans at U.S. sites.
• Establishment of systems and procedures within the regulatory department to ensure control of pre and post approval regulatory submissions, data review, adverse event reporting and labeling control.
• Development of quality agreements with partner companies and implementation of annual regulatory audits of CMOs.
• Review, submission, and management of regulatory filings and implementation of departmental procedures.
• Development of regulatory and compliance procedures for U.S. sites.
• Primary contact for FDA personnel at the center and district levels for U.S. and international sites.
• Effectively interacted with FDA representatives regarding submissions, product inquiries and corrective action plans.
• U.S. Agent contact for international sites. Effectively negotiated with FDA on a regular basis and guided foreign sites through the regulatory filing process and FDA expectations.
• Regulatory lead for due diligence teams involved in assessing product and facility acquisitions.
• Provided regulatory oversight of partner relationships. Prepared and negotiated quality agreements, performed regulatory compliance audits, and established processes for monitoring vendor performance.
• Implemented regulatory risk assessment process including the evaluation of CMC changes and impact on regulatory filings and approvals.
• Supported product development by providing regulatory strategy and guidance to in-house and external development partners.

Schering Plough Research Institute, Kenilworth, NJ,  1998 - 2006

Associate Director/Liaison, Global Regulatory Affairs, 2002 - 2006

Manager of Regulatory Affairs, Global Regulatory Affairs, 1998 - 2002

• Designed and implemented regulatory systems tailored to the company’s virtual generic division (Warrick Pharmaceuticals) which focused on drug development, regulatory approvals and product acquisitions.
• Effectively managed ANDA submission activities for the division. Responsible for project management activities for products under development including solid oral, nasal and respiratory products.
• Development of regulatory strategies to optimize project development timelines. Liaison with the FDA and the division’s contract manufacturing partners to ensure timely approvals of submitted
• Developed and implemented the regulatory compliance program (SOP program, audit program, document control, pre and post approval procedures) and ensured compliance with corporate policies and FDA requirements.
• Provided support for in-license activities of numerous products and participated in due diligence audits related to potential product acquisitions.
• Comprehensively evaluated third-party acquisitions and contract manufacturing organizations for development and commercialization of targeted products.
• Oversight of the audit program for generic drug outsourcing activities for partner contract manufacturing facilities and analytical testing laboratories.
• Management of NDA post approval submission activities within the cardiovascular therapeutic area (Schering division) and managed international product registration activities for various countriesoutside of the EU and Japan (MOW).  

Schein Pharmaceuticals, Inc., Cherry Hill, NJ, 1994 - 1998

Manager of Regulatory Affairs, 1995 - 1998

Supervisor of Regulatory Affairs, 1994 - 1995

• Responsible for the management of ANDA’s and all associated regulatory submissions resulting in numerous approvals at the New Jersey site. Established efficient and effective department procedures and provided strong leadership to the regulatory team.
• Effectively managed and trained the Regulatory Affairs department which obtained numerous ANDA approvals. Implemented Regulatory policy and procedures within the department including functional and administrative systems to ensure on-time, quality submissions to the FDA.
• Company representative to FDA throughout the pre and post approval process at the New Jersey site. 
• Managed FDA readiness activities and interacted with FDA during inspections of the site.
• Regulatory Coordinator for FDA pre-approval inspections and supported the development of 483 responses to CMC deficiencies. Interfaced with R&D, Quality, Manufacturing and Compliance departments regarding regulatory pre-approval inspection and submission observations.
• Oversight of the labeling development group and implemented labeling safety standards with the support of the Institute for Safe Medication Practices.
• Management of international regulatory submissions including Canadian registrations, responses to application deficiencies and labeling development activities. 

Enzon Pharmaceuticals, Inc., Piscataway, NJ, 1992 - 1994                                                      

Senior CMC Specialist, Regulatory Affairs

• Responsible for the coordination and submission of CMC documentation to the FDA for biological products including INDs, NDAs, ELA/PLAs, DMFs, amendments and annual reports.
• Regulatory Affairs representative during FDA pre-approval inspections and inspections by the NJ D.E.P.
• Responsible for change authorization tracking of revisions to manufacturing procedures.
• Coordinateddocumentation for the release of lots of biological products and prepared lot release submissions.
• Responsible for the review of marketing promotional and advertising materials, and preparation of SOPs for various functions within the department.

Honors & Publications

Credentials

• Quality Assurance and Regulatory Affairs – Graduate classes at Temple University School of Pharmacy, Philadelphia, Pennsylvania (Continuing Education) 

Academic and Professional Affiliations

• American Society of Health-System Pharmacists (ASHP)
• Parenteral Drug Association (PDA)
• Regulatory Affairs Professionals Society (RAPS)

Education

• B.S.   Biology, LaSalle University, Philadelphia, PA