Medical Management

Martha Beyazova, PhD, RAC

Westfield, NJ ***** (USA)

908-***-**** (Home); 908-***-**** (Cell); ******.********@*****.***

Innovative, highly trained, result-oriented pharmaceutical and Regulatory

Affairs professional with extensive experience and expertise in R&D and

medical products (drugs and medical devices): registrations, regulatory

affairs and submissions, including generation of pre- and post- approval

documentation towards lifecycle management of the product. Experience in

project management and facilitation, data integrity, and data management;

monitoring developments in regulatory environment. Excellent

organizational, interpersonal and communication skill and extensive cross

functional team work experience.

Professional Experience and Accomplishments

MBeyazova Consulting, LLC 2008 -

present

President

Provide consulting services in regulatory affairs, submissions, compliance,

and product development.

Examples of consulting services include:

- Develop document packages for regulatory submissions. Provide

Regulatory Affairs feedback and guidance.

- Perform critical reviews of key documents (scientific/technical,

labeling, promotional marketing materials, sales training materials,

SOPs, CMC, manufacturing documents, clinical protocols) for

completeness, accuracy and regulatory compliance.

- Work with cross-functional teams to ensure regulatory compliance.

- Support international registrations/license for medical devices/

drugs.

- Aid clients in development of global regulatory strategies for post-

market changes to medical products in US and international markets.

- Monitor regulatory environment to maintain expertise in regulatory

advancements, new issues, and competitive products and environmental

legislations.

Therakos, Bridgewater, NJ 2013

Senior Regulatory Specialist

- Support submissions (PMA, IDE, NDA, IND, AR and related documents),

registrations, and provide advice and insights on regulatory issues

for FDA and ROW.

PAREXEL, Waltham, MA

Independent Consultant 2012

- Data integrity audit of consent-decree pharmaceutical client. Review

of CMC data submitted in amendments, AR, deviations. Review of data

from manufacturing locations in US and India. Help clients to prepare

for FDA site audits.

- CGMP compliance and auditing of consent-decree client, quality

systems, regulatory requirements and standards.

MakroCare, Newark, NJ

Regulatory and Scientific Adviser 2009 -

current

International Flavors and Fragrances/UNILEVER, Union Beach, NJ

2005 - 2008

Biotechnology - High-Throughput Screening (HTS)

Research Fellow

- Lead joint project for the development of a new salt enhancing

product; Supervised technology transfer to major international client.

- Developed intellectual property and authored one patent.

Rutgers University, Waksman Institute, Piscataway, NJ

2004 - 2005

Cell Production and Recovery Facility

- Visiting Investigator conducted research in bioreactor fermentations

and process development. Ensured product compliance with regulatory

guidelines.

MERCK (formerly Schering-Plough Research Institute), Kenilworth, NJ

1991 - 2004

R&D, Preclinical Research, High-Throughput Screening (2002-2004)

Principal Investigator

- Lead introduction of cell based toxicity assays for testing of

compounds to reduce late-stage drop out. Developed and implemented

cell-based and biochemical assays for HT drug screening.

- Communicated results and shared ideas with stake-holders and

management, lead group discussions, provided solutions, kept track of

new publications on scientific topics and regulatory developments.

Merck Central Culture Collection (1991-2002)

Head and Curator

- Lead Culture Collection programs to maintain, preserve, and provide

Company R&D with microbial cultures and cell lines for research and

screening for new drug leads in compliance with regulatory

requirements.

- Managed microbiology laboratories, represented the team and kept

control of budget. Prepared Protocols, Test procedures, Technology

Transfer Documents and Standard Operating Procedures.

Education/Certification

RAC (2010), Regulatory Affairs Professional Society

Ph.D. Biochemistry and Microbiology, Biology Department, Sofia University,

Bulgaria

Regulatory Training

Regulatory Affairs Certificate - Medical Devices, RAPS, Baltimore, MD,

2009.

Microbial Control and Validation Certificate, New Brunswick, 2005.

New Drug Development, Regulatory Overview, Temple University, 2002.

o Periodically taking refresher courses on submissions; Medical Writing;

Medical Product Quality Systems; Clinical Trials; cGMP; Regulatory

Requirements for Pharmaceutical Products.

Contact this candidate