Regulatory Affairs Associate
Resume:
MARIA G. IANAKOVA
** * ******* ******, *******, New Jersey 07940
*********@*******.***
REGULATORY AFFAIRS ASSOCIATE
Regulatory Compliance - Guidelines Implementation - Leadership and Team Building
Strategic and Tactical Planning - Process Improvement
QUALIFICATIONS PROFILE
Quality-focused, results-driven, and visionary professional, with extensive background in pharmaceutical industry. Equipped with comprehensive knowledge in specialized areas of clinical pharmacy practice, such as quality assurance and utilization review. Equipped with in-depth knowledge in preparing and submitting documentation, proposals, and reports. Effective at building and establishing positive relationship with individuals at all levels and with diverse cultures. Able to manage numerous complex issues simultaneously within highly competitive and challenging situations. Self-starter with the ability to work under minimum supervision. Technically proficient with Microsoft Office Suite, Approve, EASY, Adobe, GlobeDoc, ISI Toolbox, ShareDoc, Viewpoint, and GIFTS.
RELEVANT EXPERIENCE
BAYER PHARMACEUTICALS - MORRISTOWN, NJ
Regulatory Affairs Coordinator 2011-Present
- Assume full responsibility in ensuring compliance with Federal regulations regarding content of FDA submissions.
- Display thorough understanding of the standard operating procedures for filing NDA, IND submissions, technical updates, and general correspondence to FDA.
- Take charge of organizing DDMAC (OPDP) submissions to the FDA; maintaining and documenting company’s regulatory files, which include annual report for electronic submissions; as well as administering and monitoring issued documents utilizing department databases.
- Hold full accountability in assessing all pertinent paperwork and document release, including batch records to manage product release while handling ongoing information on internal database
- Leverage skills in analyzing and recommending strategies on promotional product materials related to LMR while overseeing company claims regarding any promotional pieces.
- Apply best practices in technically analyzing reports included in regulatory submissions to ensure accuracy and clarity of presentation.
- Deliver exemplary performance in drafting labels for products in PLR format.
- Play a pivotal role in preparing and implementing contracts with different vendors as well as managing segregation and quality checks and write-up with SOWs, Phase IV Commitment studies, hyperlinking, and bookmarking, ensuring consistency and format of the study.
- Render exceptional support in establishing, executing, and maintaining regulatory submissions and SOPs
- Provide assistance in preparing grant proposals while maintaining an accurate master file of grants.
- Systematically developed system for tracking, listing, and updating current and past BHC promotional claims regarding products which gained approval from upper management and eventually served as a navigation tool for interested individual in learning about current claims.
OTHER EXPERIENCE
CVS PHARMACY - SHELBY TOWNSHIP, MI
Certified Pharmacy Technician 2008-2010
WAYNE STATE UNIVERSITY, NEUROLOGY DEPARTMENT - DETROIT, MI
Medical Research Intern Summer 2006-2007
EDUCATION
Master of Science in Regulatory Affairs for Drugs, Biologics, and Medical Devices - In Progress
(Expected Completion Date: September 2013)
NORTHEASTERN UNIVERSITY - BOSTON, MA
Bachelor of Science in Psychology (2010)
WAYNE STATE UNIVERSITY - DETROIT, MI
National Society of Collegiate Scholars - Chapter Inductee (2006)
PROFESSIONAL AFFILIATION
Regulatory Affairs Professional Society (RAPS) – Member: 2011–Present
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