Sara Said Omara
Regulatory affairs specialist at El Nile Company
Nasr City, Cairo, EgyptWork Experience
Innovation ProcurementFull Time
Jul 2022 - Present -2 yrs, 11 months
Egypt , Cairo
- Job Details:Procuring and reviewing certificates of analysis of raw materials and purchasing of packaging materials, compare prices and negotiate to get the best offer for both raw and packaging materials.
Regulatory Affairs ConsultantFull Time
Nov 2020 - Present -4 yrs, 7 months
Egypt , Cairo
- Job Details:Registration of cosmetic products, submitting new files and re-registration, follow up variation, follow with inspection and analysis of batches with EDA . Registration of dietary supplement products in NFSA .
Senior regulatory affairs specialistFull Time
Spimaco
Mar 2018 - Oct 2020 -2 yrs, 7 months
Egypt , Cairo
- Job Details:Registration of pharmaceutical products and submitting files to get the registration license. Preparing pamphlets, submitting lay out for approval , submitting stability files, submitting NODCAR files.
Regulatory affairs specialistFull Time
- Job Details:Registration for catheters in Europe ,Asia and USA. Registration in Competent Authority. Making technical files for all products to be applied for affixing CE mark that complying with European regulation. Receiving customer complaints and solving it and replying to the customer.
Education
Bachelor of pharmceutical scince in Pharmacy
Cairo University (CU)Jan 1999 - Jan 2004 - 5 yr
BSc in Pharmacy
Cairo University (CU)Jan 1999 - Jan 2004 - 5 yr
High School - Thanaweya Amma
Saray El KobbaJan 1998
Skills
- Regulatory Affairs
- Negotiation
- Pharmaceutical Industries
- Registration
- Administrative Affairs
- Pharmaceutical Industry
- Manufacturing Industry
- Microsoft Office
- Microsoft Office 365
- Relationship Building
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Languages
English
Fluent
Training & Certifications
Sourcing and procurement (CILT-Dip 10) in 9/2023
HPA·2023Sourcing and procurement (CILT-Dip 10)
HPA·2023CE mark, medical device directive
EGESCO·2017CE mark, ISO 13485 and Medical Device Classification
EGESCO·2017GSP, GMP, GLP , parenting , family links
Nile company, Brent councel in London, Barnet councel in London·2016Sara said omara
Good·2004