Qureos Mentor

Delta Pharma

<div>
 
 📌
 
 Key Responsibilities:
 
 
 
 
 
 <ul>
 <li>
 Prepare and review
 
 CTD dossiers
 
 for submission to the Egyptian Drug Authority.
 </li>
 <li>
 Execute regulatory activities for
 
 new registrations, variations, and renewals
 
 .
 </li>
 <li>
 Follow up with EDA on submitted files and handle
 
 deficiency letters and responses
 
 .
 </li>
 <li>
 Ensure submitted documents comply with
 
 local Egyptian and veterinary requirements
 
 .
 </li>
 <li>
 Coordinate with internal departments (R&amp;D, Quality, Production) to collect required documents.
 </li>
 <li>
 Track submission timelines and maintain proper documentation records.
 </li>
 <li>
 Support pilot batch follow-up and
 
 stability data compilation
 
 .
 </li>
 <li>
 Assist in audit readiness and regulatory documentation support.
 </li>
 <li>
 Guide junior team members on daily regulatory tasks.
 </li>
 </ul>
 
 
 
 
 
 📌 Qualifications:
 
 
 
 
 
 <ul>
 <li>
 Bachelor&rsquo;s degree in Pharmacy or Veterinary Medicine (Pharmacy preferred).
 </li>
 <li>
 
 7&ndash;13 years of experience
 
 in Regulatory Affairs in Egypt (human &amp; veterinary).
 </li>
 <li>
 Hands-on experience with
 
 EDA submission processes
 
 .
 </li>
 <li>
 Strong knowledge of
 
 CTD format and lifecycle activities
 
 .
 </li>
 <li>
 Experience in handling
 
 deficiency responses and follow-ups
 
 .
 </li>
 </ul>
 
 
 
 
 
 📌 Preferred Skills:
 
 
 
 
 
 <ul>
 <li>
 Good organizational and follow-up skills
 </li>
 <li>
 Attention to detail and compliance awareness
 </li>
 <li>
 Ability to manage multiple files simultaneously
 </li>
 <li>
 Basic team supervision
 </li>
 </ul>
 
 
</div>

Regulatory Affairs Section Head

<div>
 
 
 📌 Key Responsibilities:
 
 
 
 
 
 <ul>
 <li>
 Develop and execute regulatory strategies aligned with
 
 Egyptian regulations for human and veterinary products
 
 .
 </li>
 <li>
 Lead preparation, review, and submission of
 
 CTD dossiers
 
 to the Egyptian Drug Authority.
 </li>
 <li>
 Manage full lifecycle activities including
 
 new registrations, variations, renewals, and re-registration
 
 for both sectors.
 </li>
 <li>
 Act as the primary contact with EDA departments handling
 
 human and veterinary dossiers
 
 .
 </li>
 <li>
 Ensure compliance with all
 
 local laws, decrees, and veterinary-specific regulatory requirements
 
 .
 </li>
 <li>
 Oversee
 
 pilot batch production, stability studies, and bio/clinical or veterinary-specific data requirements
 
 .
 </li>
 <li>
 Coordinate with internal teams (R&amp;D, Quality, Production, Supply Chain) to ensure regulatory alignment.
 </li>
 <li>
 Monitor regulatory updates in Egypt and assess impact on both human and veterinary portfolios.
 </li>
 <li>
 Manage timelines, regulatory risks, and mitigation strategies to ensure timely approvals.
 </li>
 <li>
 Support regulatory inspections and ensure audit readiness.
 </li>
 <li>
 Lead, mentor, and develop regulatory team members.
 </li>
 </ul>
 
 
 
 
 
 📌 Qualifications:
 
 
 
 
 
 <ul>
 <li>
 Bachelor&rsquo;s degree in Pharmacy.
 </li>
 <li>
 
 13+ years of experience in Regulatory Affairs within Egypt
 
 , covering
 
 both human and veterinary products
 
 .
 </li>
 <li>
 Strong hands-on experience with
 
 EDA systems, submissions, and regulatory pathways
 
 .
 </li>
 <li>
 In-depth knowledge of
 
 CTD structure, lifecycle management, and veterinary regulatory requirements in Egypt
 
 .
 </li>
 <li>
 Proven success in obtaining approvals for both
 
 pharmaceutical and veterinary products
 
 .
 </li>
 <li>
 Excellent leadership, communication, and stakeholder management skills.
 </li>
 </ul>
 
 
 
 
 
 📌 Preferred Skills:
 
 
 
 
 
 <ul>
 <li>
 Strong understanding of
 
 EDA platforms
 
 </li>
 <li>
 Strategic regulatory planning across multiple product categories
 </li>
 <li>
 Advanced project management and risk assessment
 </li>
 <li>
 Strong negotiation and authority interaction skills
 </li>
 <li>
 High attention to detail and compliance-driven mindset
 </li>
 </ul>
 
 
</div>

Regulatory Affairs Manager

Join Delta Pharma and explore 2   exciting career opportunities. They're hiring for various roles with options for remote or on-site work. Apply today and become part of their innovative team.

Delta Pharma

About Company

Regulatory Affairs Section Head

Regulatory Affairs Manager