AFRA SALIH
Regulatory Affairs and Business Development Manager
Riyadh
Summary
Regulatory Affairs Specialist with 13+ years of experience managing regulatory frameworks across GCC and Europe for veterinary pharmaceuticals, vaccines, disinfectants, and feed additives. Expertise in CTD and VNEES documentation, regulatory compliance, and product registration. Strong communication skills with governmental agencies and cross-functional teams.
Overview
15
15
years of professional experience
5
5
years of post-secondary education
3
3
Languages
Work History
Regulatory Affairs and Customers Relations Manager
Madad El Awafi Veterinary Establishment
04.2024 - 01.2025
- Prepared registration dossiers (CTD, NEES, VNEES) and registered veterinary products and plants
- Ensured compliance with GMP guidelines through pre-inspection site visits
- Managed import permits and followed up with regulatory authorities
- Submitted documents for batch analysis and veterinary pharmacovigilance
Regulatory Affairs and Business Development Manager
Alpha Medical Agencies Co
01.2017 - 12.2023
- Developed and executed growth strategies
- Identified market opportunities and acquired clients
- Negotiated business plans and expanded networks
- Oversaw sales, marketing, and product development
- Built relationships and trained sales teams
- Generated new business with marketing initiatives and strategic plans
Regulatory Affairs and Business Development Manager
Apico LTD
01.2010 - 12.2017
- Prepared registration dossiers (CTD, NEES, VNEES) and registered veterinary products and plants
- Ensured compliance with GMP guidelines through pre-inspection site visits
- Managed import permits and followed up with regulatory authorities
- Submitted documents for batch analysis and veterinary pharmacovigilance
Education
Bachelor's Degree - Veterinary Medicine and Animal Production
Sudan University of Science And Technology
KHARTOUM 01.2002 - 01.2007
Skills
- Communication
- Negotiation
- Business Planning
- Project Management
- CRM
- Presentation Skills
TRAINING & CERTIFICATIONS
- Mini MBA – British Board for Training and Consulting (2023)
- RA & CTD Training – Ladder Training Consultation (2023)
- Leadership and Management | Strategic Planning | Marketing & Sales Management
- QMS & GMP for Veterinary Medicinal Products – Sudan Veterinary Council
GMP Audience – Inspection Visit to Pharmaceuticals Plant in Estonia
Training
- VICH GCP and Efficacy Studies in Animals, Munich, Germany, 2022
- Union Product Database Conference for Veterinary Medicines, Munich, Germany, 2022
- World Vaccine Congress Europe, Barcelona, Spain, 2022
- Good Manufacturing Practices Workshop, Amman, Jordan, 2021
Timeline
Regulatory Affairs and Customers Relations Manager
Madad El Awafi Veterinary Establishment
04.2024 - 01.2025
Regulatory Affairs and Business Development Manager
Alpha Medical Agencies Co
01.2017 - 12.2023
Regulatory Affairs and Business Development Manager
Apico LTD
01.2010 - 12.2017
Bachelor's Degree - Veterinary Medicine and Animal Production
Sudan University of Science And Technology
01.2002 - 01.2007
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