Summary
Overview
Work History
Education
Skills
Timeline
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Maher Abd

Port Melbourne,VIC

Summary

Ten years of experience in the pharmaceutical industry. Involved in health authority auditing of medical devices and management of prescription medicine portfolios in global markets.

Overview

10
10
years of professional experience

Work History

Principal Regulatory Affairs Associate

Seqirus
11.2015 - Current
  • Preparation of high quality applications of CMC variations to APAC, NA, PAHO and EU regions
  • Successful management of Influenza Virus Vaccine and Products of National Significance Portfolios
  • Management of Regulatory correspondence within the appropriate database to ensure regulatory compliance
  • Management of site change controls
  • Collaboratively work within the site cross-functional teams to deliver on company objective
  • Kept up-to-date with changes in regulatory legislation and guidelines and obtained marketing permissions

Departmental Officer

Therapeutic Goods Administration
03.2014 - 11.2015
  • Medical Device Assessor of class I - IIb medical devices
  • Auditing applications; assessment of product information, labeling, instructions for use and conformity assessment requirements
  • Completing assessments and recommendations for the delegate
  • Drafting decisions according to the legislative and regulatory requirements
  • Communication with sponsors
  • Review of Australian medical device regulations and guidelines

Education

Bachelor of Science - Pharmaceutical Science

RMIT University
Bundoora, VIC
12.2014

Skills

  • Prescription and Medical Device Regulation
  • eCTD
  • Agency Liaison
  • Submission Preparation
  • Project Management
  • Risk Management
  • Regulatory Compliance

Timeline

Principal Regulatory Affairs Associate

Seqirus
11.2015 - Current

Departmental Officer

Therapeutic Goods Administration
03.2014 - 11.2015

Bachelor of Science - Pharmaceutical Science

RMIT University

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Maher Abd