Sohaila Ahmed Rady
Regulatory Affairs Associate
Obour city
Summary
Regulatory Affairs Associate
Overview
8
8
years of professional experience
5
5
years of post-secondary education
2
2
Languages
Work History
Regulatory Affairs Associate
Johnson and Johnson
12.2024 - Current
- Follow up with difference regulatory Health authorities JENA Cluster (Jordan, Egypt, Ethiopia, Sudan) on Neuroscience therapeutic area.
- maintain regulatory strategy submission for renewal activities, implement AW updates, variations .
- SME Sudan and Ethiopia.
- Follow up with distributors for withdrawal and lot release for pharmaceutical products.
- Follow up with distributors for Lot release, and Post marketing surveillance for biological products
- Follow up with NODCAR requirements and fulfill inquiries concerning the under-analysis batches, till release
- Requesting the required columns, reagents, and filters to be submitted for Health Authorities in Egypt and Jordon
- Provide an annual Importation license containing all Products with its required quantities as per needed
- Accommodates importation license extensions for the required J&J crucial products - Accreditation of Certified reference materials in Egypt and Jordan.
Regulatory Affairs Specialist
Marcyrl Pharmaceutical Industries
10.2022 - 12.2024
- Follow up and answer EDA queries in timely manner until granting the final approvals and sharing them with all interested parties
- Plan the review of a new application submission corresponding to company plan as well as the EDA guidelines for submission
- Plan for the review and submission of all the maintenance activities (renewal & variations) based on company plans and the EDA guidelines
- Timely implementation of all plans with strict follow up with both internal & external stakeholders for timely achievement of the plan
- Maintain the products labeling up to date, implementing local labeling decisions, through labeling, review and approval
- Preparation, submission and follow up of pricing files
- Following and complying with all the defined internal policies and procedures of working
- Key Achievements:
- Registration for the Emergency Use Product for COVID & receiving the Approval after exactly two month from FDA Approval
- First participation in dragging active pharmaceutical Ingredient (API) listing
- Keep the current portfolio running by managing the re-registration procedures of the company products
Regulatory Affairs Specialist
Atco Pharma
01.2019 - 10.2022
- Ensure regulatory compliance with products overall strategies and Health authorities' country requirements evaluation
- Be compliant with all internal and external requirements, procedures and tools
- Foster an environment/culture of learning and sharing of best practice within the team
- Represent the regulatory position to senior management if needed
- Ensure the overall implementation of goals and strategies of the department
- Lead some specific roles especially about the establishment of objectives
Branch Manager
Al-farouk Chain Pharmacy
01.2018 - 12.2019
Shift manager
19011 chain pharmacy
01.2017 - 12.2018
Shift manager
Fouda chain pharmacy
01.2017 - 12.2018
Education
Bachelor degree - pharmaceutical science
Faculty of pharmacy MSA University
01.2012 - 01.2017
Skills
- Project Management
- Analytical Skills
- Ability to grasp new concepts quickly and to assimilate and evaluate scientific data
- Strong negotiation skills
- Creative Problem Solving
- Dynamic and excellent communication skills
- Attention to detail
Personal Information
- Date of Birth: 03/01/94
- Nationality: Egyptian
- Marital Status: Married
Timeline
Regulatory Affairs Associate
Johnson and Johnson
12.2024 - Current
Regulatory Affairs Specialist
Marcyrl Pharmaceutical Industries
10.2022 - 12.2024
Regulatory Affairs Specialist
Atco Pharma
01.2019 - 10.2022
Branch Manager
Al-farouk Chain Pharmacy
01.2018 - 12.2019
Shift manager
19011 chain pharmacy
01.2017 - 12.2018
Shift manager
Fouda chain pharmacy
01.2017 - 12.2018
Bachelor degree - pharmaceutical science
Faculty of pharmacy MSA University
01.2012 - 01.2017
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