Manager Project

PAMELA OLSON FITZPATRICK,MS, MBA, RAC

** ******** ****** . ********, ** 11782 . 631-***-**** .

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REGULATORY AFFAIRS/QA MANAGEMENT

Highly knowledgeable, results-driven Regulatory Affairs professional with

outstanding record of consistently meeting and exceeding goals, objectives,

and deadlines for investigational and new drug applications. Provide pre

and post-approval regulatory support across therapeutic areas. Coordinate

US and international regulatory filing activities, including IND, NDA, and

drug safety. Collect and disseminate regulatory intelligence involving

competitive information and new regulatory initiatives and guidances.

Provide regulatory and support to project and cross-functional teams. Hold

multiple certifications, as well as MBA and MS and BS in Biology.

PROFESSIONAL EXPERIENCE

OSI PHARMACEUTICALS, INC., Melville, NY 2000 - Present

Manager, Regulatory Affairs - Provide regulatory support for marketed

and investigational oncology, diabetes, and ophthalmology products in the

U.S, Canada, and Europe. Regulatory liaison for Tarceva , a marketed

oncology product with approximately $1.7 billion in global sales. Ensure

regulatory compliance throughout the pre and post approval product

lifecycle.

. Regulatory Approval: Regulatory team member for successful

priority review NDA and two sNDAs. Flagship oncology product received

FDA approval after 3 month review.

. Clinical Trials: Support pivotal domestic and international

trials critical to NDA and sNDA approvals, including reviewing CTS

labels, drug shipment requests, informed consents, and site

documentation.

. Product Development: Oversee approval compliance in new

investigational drug activities.

. Cross-Department Collaboration: Coordinate involvement of all

departments (nonclinical, pharmacology, chemistry manufacturing and

controls, clinical, publishing, and marketing) in maintaining

regulatory approval status.

. IND, eCTD NDA, & sNDA Submissions: Regulatory liaison for

successful IND, NDA, and sNDA filings

. Process Development & Improvement: Develop departmental SOPs

and coordinate SOP review process.

. Global Regulatory Affairs: Coordinate regulatory filings

including global IMPD development in Europe, North/ South America, and

Asia Pac.

. Strategic Planning: Member global regulatory planning and cross

functional strategy teams. Part of rapid response team answering FDA

questions during NDA/sNDA reviews. Participant ad hoc ODAC, field

alert, and FDA inspection teams

. Project Management: Oversee department projects in various

developmental and approval stages. Lead weekly update meetings

disseminating information on all new regulatory initiatives. Track new

oncology approvals and drugs in pipeline.

. Current & Future Needs Analysis: Evaluate and recommend filing

strategies including orphan indication, fast track, and accelerated

approval.

. Report Generation: Coordinate the IND and NDA annual report

compilation and filing. Oversee periodic safety reporting per

regulatory requirements. Prepare post-marketing study updates.

. Staff Training & Supervision: Trained department executive

coordinator and coordinate support staff's efforts.

. FDA Relations: Communicate with FDA project manager(s)

throughout the entire approval timeline via written, telephone, and

face to face interactions. Proactively respond to filings of adverse

events. Coordinated smooth and efficient FDA inspection and Field Alert

response.

. Product Support: Provide regulatory expertise for marketed and

developmental ophthalmology, oncology, diabetes and obesity drugs.

Monitor post-NDA marketing commitments.

. Industry Collaboration: Work closely with Roche and Genentech

RA with respect to NDA filings and Abbott/Dako RA regarding PMA

(diagnostic) filings.

. Technology: Led interdepartmental use of e-rooms for enhanced

communication and efficiency. Created electronic archiving system.

Continued

PAMELA OLSON FITZPATRICK, MS, MBA, RAC Page Two

PROFESSIONAL EXPERIENCE continued

QUEST DIAGNOSTICS/METPATH 1986 - 2000

Islip and Syosset, NY

Manager, Quality Assurance and Environmental Health and Safety -

Advanced through several company transitions, earning promotions from

Sales/Service Coordinator to Laboratory Technologist and Quality Control

Specialist, concurrently functioning as Manager of QA and EH&S.

. QA Management: Developed and implemented facility-wide quality

assurance program, managing all business unit QA activities including

SOP development and review, root cause analysis, and QC surveillance.

. EH&S Management: Developed and directed facility-wide

Environmental Health & Safety program.

. Achievements: Led Islip business unit to the highest score in

the country for EH&S performance. In 1999 received award as #1 in US

for excellence in proficiency testing and most improved business unit.

. Training & Testing: Created and implemented comprehensive,

facility-wide QA training program. Developed and maintained internal

and external proficiency testing programs.

. Investigation Control: Initiated and oversaw incident

investigation and response process. Established customer complaint

investigation and response policies and procedures.

. Department Leadership: Chaired Quality Assurance and EH&S

meetings.

. Relationship Management: Maintained ongoing communication with

regulatory agencies. Served as corporate quality and EH&S

representative and liaison.

. Safety: Created comprehensive facility-wide safety program

covering BBP compliance, OSHA formaldehyde standard, radiation safety,

and safe operations of clinical laboratory, vehicle fleet, and patient

service centers.

. Internal & External Auditing: Led audits of local and other

regional facilities and followed up to ensure completion of

recommendations and corrective actions. Coordinated internal and

external compliance assessment programs.

EDUCATION & CREDENTIALS

DOWLING COLLEGE, Oakdale, NY

Post-Masters Certificate in Total Quality Management

Master of Business Administration (MBA)

ADELPHI UNIVERSITY, Garden City, NY

MS in Biology

BS in Biology (cum laude)

Numerous RAPS & DIA classes

Regulatory Affairs Professional Society: Regulatory Affairs Certified (RAC)

American Society for Quality: Certified Quality Manager

American Society for Quality: Certified Quality Auditor

NYS DOH Laboratory Technologist Qualified

Center for Healthcare Environmental Management: Healthcare Environmental

Manager

SKILLS

Microsoft Office Suite; Outlook, Word, Excel, PowerPoint, Access, Visio,

Oracle, EDMS, E Rooms, Webex, Adobe

PROFESSIONAL AFFILIATIONS

Regulatory Affairs Professionals Society (RAPS)

Drug Information Association (DIA)

American Society for Quality (ASQ)

Highlights include:

. Provide product lifecycle regulatory support for developmental and

marketed products; IND/CTA, NDA, sNDA, and Drug Safety

. Created electronic archiving system, maintain approved oncology drug

database, review orphan designations, monitor advisory committee activity

. Led initiative to obtain pediatric exclusivity for pharmaceutical

product, including attending FDA meetings and leading internal team.

Demonstrated strengths :

. Regulatory Liaison

. FDA Relations

. Process Improvement

. Technical Writing

. SOP Review & Analysis

. Product Launch

. Risk Assessment & Mitigation

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