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User ID
Asma H. - 14938
Toronto, Canada
10:31 AM, GMT -05:00
Asma H. - 14938 Regulatory Affairs Associate from Toronto
About
15+ years of experience in Regulatory Affairs, Project Management, Biosimilars, Supply Chain &
Logistics in Pharmaceutical Industries including 7+ years of hands-on experience with Regulatory
Information Management Systems(RIMS).
Strong leadership and team management skills with a proven record of establishing practices and
successfully leading teams and projects practiced through various projects and different roles and
responsibilities
Dedicated and hardworking strategist accustomed to work in dynamic cross-functional agile teams
and lead strategic Regulatory Affairs projects for different partners and licensors.
Extensive knowledge of MENA Pharmaceutical and Biosimsilar Regulations, Submission
Requirements, Submission strategies and pathways.
Solid knowledge and strong analytical skills in Supply Chain and Global Logistics that was refined
through applied courses at Seneca College, School of International Business & Management
Occupation
Regulatory Affairs Associate
Work experience
2020 - Present
Regulatory Affairs Consultant- Freelancer
Pharmalex
2019 - Present
Global Pharma Key Opinion Leader (GPKOL)
KOREA HEALTH INDUSTRY DEVELOPMENT INSTITUTE'S (KHIDI)
2017 - 2019
Strategy and Planning Regulatory Affairs Manager
HIKMA PHARMACEUTICALS
2011 - 2017
Regulatory Affairs Manager
HIKMA PHARMACEUTICALS
2006 - 2011
Regulatory Affairs Supervisor
DAR AL DAWA DEVELOPMENT & INVESTMENT CO.
Education
2021 - 2021
Seneca College
Diploma
2001 - 2006
University of Jordan
Bachelor of Science
Skills
Audit
17 Y
Business Planning
17 Y
Business Processes
17 Y
Communication
17 Y
Due Diligence
17 Y
Logistics
17 Y
Managerial Skills > Team Management
17 Y
Negotiation
17 Y
R&D
17 Y
Regulatory Affairs
17 Y
research skills
17 Y
Supply Chain
17 Y
Supply Chain Management
17 Y
Other skills
adaptable to changes
Biosimilars
critical thinker
decision making
eCTD
flexible to change
global crossfunctional team leadership
multicultural team management
offshore team management
organisation skills
project team management
regulatory strategy
regulatory submissions
About
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