Pharmaceutical and medical device regulatory affairs expert with major company and FDA employment experience.

Pharmaceutical and Medical Device Regulatory Affairs Expert: Filing and Compliance (1296)

cGMP auditing of drug and devices, including US agent for foreign firms.
cGMP training for domestic and international clients.
17 years employment with FDA as chemist, investigator and compliance officer.
Directed the activities of an FDA laboratory as well as several laboratories in Industry.
PAI approvals for new and existing start-up facilities, NDA/ANDA approvals.
Compliance, active with multiple CAPA for FDA consent decree – third party role.
Readying, filing and responding to FDA deficiency letters on filed application.
Experienced responding to FDA deficiency letters and FDA 483 observations.
RAPS certified with over 30 successful application approvals at the FDA.
cGMP lab upgrade including directing regulatory, quality assurance and quality control groups.
Trained thousands of employees on how to prepare for an FDA inspection
Quality systems in pharmaceutical and medical device production.

President & Pharmaceutical Consultant, 2000-present

Solutions to FDA issues. Submissions, deficiency letters, FD-483 responses, plant and product approvals, PAI, CGMP, training for domestic and international clients to gain FDA approvals and maintain Regulatory Compliance for products, plants, API, finished dosage, and for a full range of products, including Devices. Schering Plough Consent Decree remediation team.
Senior Director, Regulatory Affairs & Quality Assurance for Yamanouchi Pharma Technologies. Regulatory/Quality/compliance support for contract manufacturing. Responsible to host all regulatory inspections including Pre-Approval Inspections (PAIs). Created, developed, staffed & manage Vendor Qualification department.

RANBAXY PHARMACEUTICALS, INC., 1995-1998

Executive Director, Regulatory Affairs, All regulatory, compliance, and quality activities within Region IV (North & South America). Primary advisor on all FDA regulatory matters for a reporting staff in Regulatory, Compliance, and Quality areas. All US regulatory and Pre-Approval Inspection matters involving Ranbaxy Laboratories Limited, India were handled on behalf of the parent company, while serving in the capacity of US Agent. Management of all activities relating directly or indirectly to FDA submissions: ANDA, AADA, NDA, DMF, Supplements, Amendments, responses, Annual Updates.

STERLING DRUGS (Sanofi-Winthrop division), 1994

Director of Regulatory Affairs, Filing of all generic drug submissions, Medical Devices support and all communications to and from the FDA concerning any pending applications. Filings and interactions with FDA on behalf of the company resulted in the ultimate approvals of 15 ANDA.

RUGBY-DARBY, INC., 1991-1993

Corporate Director of Quality Assurance and Regulatory Compliance, Assured 5 manufacturing locations remained in compliance with all federal, state and local regulatory requirements and comply with company quality standards. Removal of the company from the FDA alert list. Developing and conducting Business-Ethics cGMP training to all company employees.

ABBOTT LABORATORIES, 1987-1990

FDA Liason, Regulatory guidance to $1 billion division. Designated company representative during FDA inspections for Drugs, Medical Devices, and Infant Formula, corporate resources were coordinated to respond to regulatory issues identified by FDA inspection of the pharmaceutical operations at Abbott Park, and Ross divisions located at four remote manufacturing facilities.
Numerous new product approvals included nine PMA (Pre-Market Approvals) permitting the manufacture of those products.

BAUSCH & LOMB, 1983-1987

Compliance specialist, Corporate Regulatory information source for the entire corporation; primary responsibility for start-up at the original sterile contact lens solution (Medical Device) plant. No FD-483 was issued during the subsequent five years post-approval.

U.S. FOOD AND DRUG ADMINISTRATION, 1966-1983

Diversified experiences were obtained serving in the capacity of Chemist, Investigator, Compliance Officer, and Supervisory Chemist with the Atlanta and Cincinnati Districts, including participation in training assignments in Washington, ~Supervisory Chemist, Atlanta Regional FDA Laboratory. Participated directly in the historically significant Tylenol tampering incident resolution.
FDA Investigator, Cincinnati District FDA, Drug cGMP inspection upon completion of the training regimen required for all FDA investigators.