Sara K. Sadeddin
Amman,Jo
Summary
Proficient, forward-thinking, result-oriented and professional with 9+ years in regulatory affairs; Seeking a management position in a reputable company where I can utilize my skills, knowledge, and artistic abilities to make a positive impact and contribute to the overall goals of the organization.
Overview
10
10
years of professional experience
Work History
REGULATORY AFFAIRS MANAGER
ULFA PHARMA CO
03.2017 - Current
- Lead the regulatory affairs department, ensuring timely registration, re-registration, and post-approval processes per Jordan FDA regulations.
- Prepare and review eCTD registration files, manage pricing updates, and oversee compliance.
- Liaise and negotiate with the Jordan FDA, ensuring smooth product approvals.
- Maintain and update an organized regulatory database for streamlined operations.
- Supervise pharmacovigilance, quality control procedures, and product pricing strategies.
REGULATORY AFFAIRS / QUALITY ASSURANCE OFFICER
ULFA PHARMA CO
03.2015 - 03.2017
- Prepared and reviewed CTD registration files and managed post-approval changes.
- Oversaw import invoices, JFDA submissions, and quality control lab follow-ups.
- Ensured compliance with Good Distribution Practices (GDP) and Quality Management System (QMS).
- Conducted warehouse and vehicle monitoring, calibration, and pest control supervision.
- Managed customer complaints and ensured compliance with regulatory requirements.
Education
BACHELOR OF PHARMACY -
University of Jordan
2014
Scientific
Modern System school
2009
Skills
- Willingness to learn
- Communication, Problem
- Solving, and Negotiation skills
- Team Work capability
- Critical and Strategic Thinking
- Time Management
- Organizational skills
- Analytical Skills
- Leadership skills
- GxP knowledge
- Microsoft Office software
Accomplishments
- ICH Guideline for Q1(Q1A(R2) THROUGH Q1D), Q3 (Q3A(R2) & Q3B(R2))
- Q5 (Q5C), AND Q6 (Q6A), by Jordan FDA 2023 PV & Rational Drug use regulation in Jordan, by Jordan FDA 2023 Biologicals, Biosimilars & Vaccines Regulations in Jordan, by Jordan FDA 2023 Pricing Regulations & API variations in Jordan, by Jordan FDA 2022 Annual Report Submission, by Jordan FDA 2022 Fast Track Files & Manufacturing Sites Accreditation, by Jordan FDA 2022 Advance Drug’s Pricing, by International Collage in London 2022 PV Good Practices, by Jordan FDA 2019 Medical devices Regulation & Registration, by Jordan FDA 2019 The eCTD Submission Training, by the DOA 2018 Value Added Medicines New Regulation, by Jordan FDA 2018 Good Storage & Good Distribution Practice workshop, by Jordan FDA 2018 Post Approval Changes on Registration Drugs New Guidelines 2017,by Jordan FDA – Landmark 2017 Health, Safety and Environment Training - Certified Health and Safety
- Supervisor, by Safety Team Co
- 2016 Evaluation of Quality Control Lab File (Validation & Technical), by Jordan
- FDA – Landmark 2016 PV System Master File and Inspection, by Jordan FDA 2015
Languages
References
REFERENCES
References and certificates are
available upon request
Timeline
REGULATORY AFFAIRS MANAGER
ULFA PHARMA CO
03.2017 - Current
REGULATORY AFFAIRS / QUALITY ASSURANCE OFFICER
ULFA PHARMA CO
03.2015 - 03.2017
Scientific
Modern System school
BACHELOR OF PHARMACY -
University of Jordan
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