Oksana Golycheva
Skillman,NJ
Summary
16 years of Global CMC RA experience
· Strong knowledge of global regulatory laws and regulations in all stages of drug development
· Consistent track record of CMC strategies leading to successful approvals of Invega Trinza and Invega Hafyera original applications in US, EU, Japan, Brazil and other global markets
Overview
17
17
years of professional experience
Work History
Global Regulatory Affairs CMC Associate Director
Johnson & Johnson (Janssen R&D)
01.2012 - Current
- Provide CMC Regulatory expertise including regulatory risk assessments and mitigations associated with proposed strategies in all stages of drug development from clinical trial applications and original filings to post-approval variations. Confirm CMC strategy is in alignment with Therapeutic Area, regional strategies, commercial strategy, and Target Product Profile
- Assist in the preparation of dossiers for submission to Health Authorities (NDA /MAA/IND/CTA/JNDA). Develop regulatory strategies and author responses to Health Authority questions
- Hands on experience with Global Health Authorities including US FDA, Russian MoH, African MoHs. Provided CMC RA support with on-site HA inspection in Titusville, NJ
- Coach and develop the associate colleague on CMC RA activities, assessment of change controls, filing strategies and preparation of regulatory dossiers and health authority responses
- Area network representative for eastern European cluster of countries. Liaise between affiliate and CMC RA departments, created guidance documents and procedures to manage Normative document. Lead efforts for transition of all products to EAEU legislation. Organize yearly presentations to update CMC RA department on changes to local regulations.
Global Regulatory CMC Marketed Product Manager
NOVARTIS Inc.
04.2011 - 01.2012
- Drive regional and global CMC regulatory strategies and act as a single point of contact for assigned marketed products, maximizing the business benefit balanced with regulatory compliance
- Proactively communicate CMC regulatory strategy, key issues and any other critical topics to interdisciplinary project teams and to management
- Lead and implement all regional CMC submission activities (planning, review, coordination, submission) for assigned products, while applying the global strategy into regional submissions.
- Initiate and lead regional Health Authority interactions and negotiations; setting objectives, preparing briefing books, coordinating and planning rehearsals.
- Lead preparation of CMC dossier risk analyses, contingency plans and Lessons Learned documentation on major submissions for communication and action planning with subteams
Global Regulatory CMC Specialist (Product Principle)
PFIZER Inc.
01.2008 - 01.2011
- Provide Regulatory CMC support for global implementation of RTRt (Real Time Release testing) utilizing Process Analytical Technologies (PAT) and QbD principles) for key Pfizer product (FDA approved)
- Develop regulatory original and post-approval filing strategies and evaluate the risks utilizing Pfizer risk management practices.
- Author and coordinate timely responses to FDA and worldwide Health Authority queries and requests for CMC information
- Author regulatory CMC submissions for submission globally in eCTD and NeeS formats as per the ICH and Pfizer standards (NDAs, QES License renewals, Full dossier upgrades, Variations, CBE-30, PAS, Annual Reports, Briefing Packages and other supplements and amendments)
- Provide regulatory assessment of change controls
- Represent Regulatory CMC in cross-functional team project (including MLP and Supply Chain) to analyze and develop product specific global submission strategies and launch/implementation timeframes for US, EU, AP, LA/CA, MEWA markets
- Coordinate Source Requests and Tenders for territory/line extensions
- CMC single point of contact for Russia, Ukraine, Moldova, Uzbekistan, Croatia, Kazakhstan, Armenia, Georgia, Belarus
Release Associate, Vaccines
Merck
01.2008 - 09.2008
- Performed batch record quality audit for lyophilized (freeze-dried) vaccines and sterile pharmaceuticals (M-M-R®II, RotaTeq®, VARIVAX®, ZOSTAVAX®).
- Facilitated the release of product and ensured proper control of material through maintenance of the quarantine computer systems (IMPACT and WATS)
- Tracked and maintained change control systems in quality control and operations area
- Ensured proper identification of release status of bulks and fills through physical identification and through the use of computer databases
- Became knowledgeable in Federal and other regulatory agency regulations to assure all areas are in compliance
- Represented West Point Product Release as a liaison to the operations areas through the evaluation and resolution of quality issues (cross-functional collaboration meetings). Participated in 5S project
Quality Assurance Auditor I
TEVA Pharmaceuticals
06.2007 - 01.2008
- Performed audit of master batch records, Quality Control qualifications and CoAs to verify compliance to regulatory and quality requirements
- Conducted incident and deviation investigations and proposed appropriate preventative corrective actions for associated issues and events
- Reported deviations from procedures/processes to Quality Assurance Management and initiated appropriate actions
- Performed timely releases of Raw Materials, In-Process and Finished product lots
- Performed Potency calculations for manufacturing operations
- Represented Quality Assurance on cross-functional team meetings
- Acquired excellent knowledge in cGMP requirements.
Education
BS in Pharmaceutical Sciences -
University of the Sciences in Philadelphia (USP)
05.2007
Skills
Small molecules: Expertise in sterile manufacturing and drug device combination products (Invega Sustenna, Invega Trinza, Invega Hafyera)
Biologics: Learning biologic regulations by supporting a monoclonal antibody (Tremfya)
Accomplishments
AAPS Steering committee member
Speaker/ host for Annual CMC forum with representatives from various pharmaceutical companies and US FDA to discuss CMC related hot topics. Hosted the AAPS meeting twice at JNJ.
Speaker at 21st APIC conference
Drug Information Association (DIA) member:
Completed Regulatory Affairs: Part I: The IND Phase and
Part II: The CTD/NDA Phase Course
Internship
Summer Intern (May 2006 - August 2006)
Global Health Outcomes Assessment, Wyeth Pharmaceuticals, Collegeville PA
Development of a Pharmacoeconomic Model for Pandemic Flu:
Comprehensive literature search, clinical data analysis, calculations for disease incidence rate, attack rate, life years gained, cost per life years gained, Mucus hypersecretion: clinical variables and patient outcomes. Developed a Health Questionnaire
Timeline
Global Regulatory Affairs CMC Associate Director
Johnson & Johnson (Janssen R&D)
01.2012 - Current
Global Regulatory CMC Marketed Product Manager
NOVARTIS Inc.
04.2011 - 01.2012
Release Associate, Vaccines
Merck
01.2008 - 09.2008
Global Regulatory CMC Specialist (Product Principle)
PFIZER Inc.
01.2008 - 01.2011
Quality Assurance Auditor I
TEVA Pharmaceuticals
06.2007 - 01.2008
BS in Pharmaceutical Sciences -
University of the Sciences in Philadelphia (USP)
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