Yousef Alharbi, Regulatory and Government Affairs Manager

Yousef Alharbi

Regulatory and Government Affairs Manager

Nutricia Middle East DMCC (part of Danone group)

Location
Saudi Arabia - Riyadh
Education
Master's degree, Herbal Medicines
Experience
18 years, 2 Months

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Work Experience

Total years of experience :18 years, 2 Months

Regulatory and Government Affairs Manager at Nutricia Middle East DMCC (part of Danone group)
  • Saudi Arabia - Riyadh
  • My current job since November 2018
1. Head, Herbal and Health Product Division at Saudi FDA
  • Saudi Arabia - Riyadh
  • My current job since October 2010

- Peer-reviewed quality assessment reports created by assessment officers for completeness and accuracy.
- Recommended the acceptance or rejection of safety and efficacy aspects of submissions.
- Seating and updating regulatory frameworks and guidelines.
- Assessing the quality part of the dossier of therapeutic goods mainly herbal and health products.
- Classifying the therapeutic goods which require or not require premarket approval.
- Inspecting the Pharmaceutical manufacturing sites to assure compliance with GMP guideline.

Current membership
• International regulatory cooperation for Herbal Medicines, WHO.
• Herbal and health product registration committee, Saudi FDA.
• Classification committee, Saudi FDA.
• An import permit of narcotic plants seeds Committee, ministry of interior.
• The Natural Health Product Research Society's of Canada.
• National Pharmacovigilance and drug safety center (NPC).


Past membership
• Blood products temporary committee, Saudi FDA.
• Raw herbal material standards temporary committe, Saudi FDA.
• Food with medical claims temporary committee, Saudi FDA.

2. Supervisor, Herbal and Health Product Division at Saudi FDA
  • Saudi Arabia - Riyadh
  • December 2008 to October 2010

- Recommended the acceptance or rejection of safety and efficacy aspects of submissions.
- Assessing the quality part of the dossier of therapeutic goods mainly herbal and health products.

3. Assessment officer at Saudi FDA
  • Saudi Arabia - Riyadh
  • March 2006 to December 2008

Assessing the quality part of the dossier of therapeutic goods

Education

Master's degree, Herbal Medicines
  • at Sydney University
  • January 2009
Bachelor's degree, Pharmaceutical science
  • at King Saud University
  • February 2006

Specialties & Skills

Pharmaceutical Development
Pharmaceutics
Regulatory Affairs
Quality Assurance
Highly competent with Microsoft Office; access, excel, word and power point.

Languages

English
Expert
Arabic
Expert

Memberships

Saudi FDA, WHO and Ministry Of Interior
  • under experience section above
  • January 2009

Training and Certifications

Project Management Professional (PMP) (Training)
Training Institute:
Saudi_FDA
Date Attended:
September 2018
Introduction to Regulatory Affairs in the EU (Certificate)
Date Attended:
January 2019
The Complete Course on Management (Certificate)
Date Attended:
September 2015
Strategy & Strategic Planning (Certificate)
Date Attended:
May 2016
Identify KPIs, concrete progress and constructive benefit (Certificate)
Date Attended:
May 2017
Supervisor and team leader skills (Certificate)
Date Attended:
May 2017
Challenges in Drug/device combination products (Certificate)
Date Attended:
October 2017
Valid Until:
January 2013