Senior Manager/Associate Director

QUALIFICATIONS PROFILE

Customer-focused, analytical and performance-driven senior-level professional offering 16 years of US and international regulatory experience combined with in-depth knowledge in overall aspects of drug development and regulatory submission process.

Core competencies:

- Known as proactive and results-driven leader with proven record of success in directing diverse group of individuals to deliver peak performance and achieve common goal.

- Utilize strategic thinking skills and detail-oriented approach in preparing content for regulatory submissions and updating documents during product life-cycle including renewals and variations. Experienced working with various associations and regulatory authorities to clarify and resolve regulatory matters.

- Highly adept at composing and proofing materials, establishing priorities, scheduling and meeting deadline; constantly contribute in the creation of related regulatory strategies to steer development.

- Reputed for sound regulatory knowledge with articulate oral and written communication skills; keynoted speaker in multiple international conferences on OOS investigations, laboratory controls, and stability program.

TECHNICAL PROFICIENCY

Computer Software Validation for GMP Purpose - Documentum - MS Office - SAP - TrackWise Tracking System

iLIMS - Project Management - LotusNotes - Visio - SCORE - GXPharma

PROFESSIONAL EXPERIENCE

TEVA Pharmaceuticals (formerly Barr Pharmaceuticals) - Woodcliff Lake, NJ

REGULATORY AFFAIRS MANAGER, U.S. REGULATORY AFFAIRS DEC 2008-PRESENT

- Provide primary leadership in overseeing all aspects of regulatory affairs function to support new product development and provide direction on formulation IIG limit, impurity limit, dissolution test requirement, BE study requirement, Q1/Q2 requirement, as well as communicate with FDA on these requirements

- Prepare and file original ANDA, IND, NDA, 505 (b) 2 and CTA

- Analyze required data and review scientific reports as well as other written documents

- Coordinate pre- and post-approval submission activities through telephone amendment, deficiency letters, bioequivalence amendment, patent amendment, annual reports, CBE 30, CBE 0, and prior approval supplement

- Evaluate regulatory impact of all modifications for manufacturing, testing, and release of clinical and marketed products

- Effectively serve as correspondent on FDA comment letters

- Develop and track project schedule to ensure achievement with established objectives

- Collaborate regulatory agencies, monitor change of Patent IV, citizen petition, and orange book in regulatory environment, and analyze impact on internal projects and operations

Barr / Pliva - Zagreb, Croatia

REGULATORY AFFAIRS MANAGER, U.S. REGULATORY AFFAIRS MAR-DEC 2008

- Submitted original applications with European regulatory agency (MAA) through Mutual Recognition-MRP, Decentralized-DCP as well as national filing

- Administered registration dossier for European (MAA) filings and updated the regulatory documents during product life-cycle including renewals and variations

- Functioned as correspondent on deficiency letter from healthcare authority

- Played a pivotal role in the implementations of Regulatory Affairs Change Control TrackWise and IBM SCORE systems

Key Accomplishments:

- Successfully managed overall functional areas of upgrade project in preparation of Crotia to join EU

- Effectively answered deficiency letters while ensuring strict adherence to EU directives, ICH, CHMP and CPMP guidance as well as best practices

- Proactively involved in two key patent challenge projects and obtained first-to-file status

- Responded FDA deficiency letters on a key product and met the first-to-market launch date

- Managed and maintained records of multiple successful ANDA filing

GlaxoSmithKline - Parsippany, NJ

SENIOR REGULATORY AFFAIRS ASSOCIATE, REGULATORY AFFAIRS (MEDICAL DEVICES) 2006-2008

- Prepared technical documents for CE Marking and international registration dossier to assist new core products and line extensions for medical device

- Applied Export Certificate from FDA to assist local registration

- Coordinated with notified body on Class IIa and Class IIb medical device and electrical medical device

- Worked closely with medical, clinical, formulation, analytical and microbiology groups to obtain claim support

- Collaborated with global Regulatory Affairs to ensure compliance with local regulatory requirements

- Functioned as Deputy Management Representative ensuring compliance with ISO 9001, ISO 13485, ISO 14971, and the Medical Devices Directive (93/42EEC)

- Spearheaded a team to develop and implement TrackWise System for change control, deviation/investigation

SENIOR QA SPECIALIST, R&D QUALITY ASSURANCE AND COMPLIANCE 1999-2006

- Analyzed and approved manufacturing and packaging batch records, specifications, COAs, formulation sheets, product development reports and test methods

- Involved and contributed in pilot plant batch manufacturing and scale up process validation in commercial site

- Conducted stability studies to assist in submission and commercial expiry

- Assessed and approved protocols and reports concerning analytical method validation, cleaning validation, and method transfer

- Provided primary leadership in directing specification investigation

- Established ISO 90001 and ISO 13485 quality system

- Developed TrackWise system for OOS, deviation, Change Control, Product quality incident and CA/PA

- Administered Change Control Requests from the manufacturing plant to Regulatory and assessed changes to ensure implementation of modifications in accordance with the guidelines while ensuring compliance with department SOPs as well as with health authorities

Key Accomplishments:

- Successfully led a team to develop and implement TrackWise system, which was recognized as the most popular and widely used system at GSK for change control, deviation and investigation

- Utilized exceptional project management expertise in directing five active projects simultaneously with high level of activities to obtain CE Mark for devices

- Led the successful implementation of quality system to obtain the ISO90001 and ISO13485 certificate

- Played a key role in the approval of GSK stability and analytical method validation package in support of CTA, MMA and NDA filing

OTHER EXPERIENCE

Teva Pharmaceuticals - Fairfield, NJ

CHEMIST, QC LABORATORY SUPERVISOR AND LABORATORY AUDITOR, QUALITY CONTROL 1994-1999

Grow Company, Inc. - Hackensack, NJ

RESEARCH CHEMIST, RESEARCH AND DEVELOPMENT 1993-1994

EDUCATION

MASTER OF SCIENCE IN POLYMER CHEMISTRY - University of Detroit - Detroit, MI

GRADUATE STUDIES IN ANALYTICAL CHEMISTRY - University of Lyon - Lyon, France

BACHELOR OF SCIENCE IN BIOCHEMICAL ENGINEERING - East China University of Chemical Technology - Shanghai, China

PROFESSIONAL TRAINING

- Webinars and Seminars: Labeling, eCTD Submission, FDA Foreign Inspection, Country of Origin, Top Ten Mistakes Companies Have Made When Interacting with FDA, European Perspective on Risk Management, Medical Device Promotion, RoHS and Prop 65, FDA ANDA Life Cycle and Quality by Design

- Soft Skills Training

- Lean and Six Sigma

- ISO 9001, ISO 13485, ISO14971 and IEC 60601

- Global Harmonization Task Force

PROFESSIONAL AFFILIATIONS

Member, Regulatory Affairs Professionals Society (RAPS)

Member, Generic Pharmaceutical Association (GPhA)

LANGUAGE PROFICIENCY

English, Chinese, and working knowledge in French

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