Nermien Grace
Regulatory Affairs
Giza
Summary
Dynamic Regulatory Affairs professional with a proven track record , adept at driving regulatory strategies for innovative products. Known for a friendly, positive attitude and exceptional attention to detail, I excel in collaboration with teams and have successfully navigated complex submissions to ensure Regulatory compliance.
Overview
9
9
years of professional experience
7
7
Certifications
3
3
Languages
Work History
Regulatory Affairs Supervisor
GE Healthcare
01.2022 - Current
- Support regulatory strategy for product development and lifecycle management including renewals, Variations & post authorization commitments.
- Maintain effective working relationships with other business units as Manufacturing, quality and Marketing.
- Respond to Health authorities queries within effective time-plan
Senior Regulatory Affairs Specialist
Soficopharm
01.2021 - 12.2021
- Liaise Between Foreign Vendors & Health Authorities to maintain Pharmaceuticals and Medical Devices Supply to Egypt.
- Working on getting Approvals From Authorities within previously assigned time plan.
Regulatory Affairs Specialist
Pharmaceutical Egyptian Association
01.2019 - 12.2020
- Assist with the Team in maintaining Products Life Cycle from Regulatory aspect.
- Working on Diversified categories of Products including active and inactive Pharmaceutical, Veterinary & Supplements Raw Materials.
Regulatory Affairs Specialist
Cipla Pharmaceuticals
01.2016 - 12.2018
- Prepared and submitted regulatory file applications and supporting documentation.
- Obtained Marketing Authorization Approvals for Biologicals, Pharmaceuticals, Medical Devices & Food Supplements.
Education
Post-Baccalaureate Diploma - Microbiology
Cairo University
Cairo 04.2001 -
Bachelor's Degree - Veterinary Medicine
Cairo University
Cairo, Egypt 04.2001 -
Skills
Demonstrates Initiative
Supportive interpersonal skills
Collaborative teamwork
Experienced in software utilization
Detail-oriented professional
Strong organizational skills
Effective under pressure
Certification
Training Program on Preparation of CTD files according to Prequalification Requirements & EMA/FDA approval.
Timeline
Regulatory Affairs Supervisor
GE Healthcare
01.2022 - Current
Senior Regulatory Affairs Specialist
Soficopharm
01.2021 - 12.2021
Regulatory Affairs Specialist
Pharmaceutical Egyptian Association
01.2019 - 12.2020
Regulatory Affairs Specialist
Cipla Pharmaceuticals
01.2016 - 12.2018
Post-Baccalaureate Diploma - Microbiology
Cairo University
04.2001 -
Bachelor's Degree - Veterinary Medicine
Cairo University
04.2001 -