About DP World
Trade is the lifeblood of the global economy, creating opportunities and improving the quality of life for people around the world. DP World exists to make the world’s trade flow better, changing what’s possible for the customers and communities we serve globally.
With a dedicated, diverse and professional team of more than 115,000 employees from 160 nationalities, spanning 78 countries on six continents, DP World is pushing trade further and faster towards a seamless supply chain that’s fit for the future.
We’re rapidly transforming and integrating our businesses -- Ports and Terminals, Marine Services, Logistics and Technology – and uniting our global infrastructure with local expertise to create stronger, more efficient end-to-end supply chain solutions that can change the way the world trades.
What's more, we're reshaping the future by investing in innovation. From intelligent delivery systems to automated warehouse stacking, we’re at the cutting edge of disruptive technology, pushing the sector towards better ways to trade, minimizing disruptions from the factory floor to the customer’s door.
DP World is on a mission to transcend boundaries and bridge the gap between all nations and cultures – not just in what we do but also in how we behave.
We are dedicated to creating a culture where everyone feels respected, supported, and empowered to reach their full potential. We believe that embracing inclusion and diversity, drives innovation and growth and helps us connect people, businesses, and societies. Free minds and different perspectives are changing our world, and together we can change what’s possible.
WE MAKE TRADE FLOW TO CHANGE WHAT'S POSSIBLE FOR EVERYONE.
About the Role
For Logistica A DP World Company
Job Purpose
- Oversees regulatory submissions, agency communications, quality management compliance, regulatory inspections, documentation, and cross-functional support to ensure products and operations meet local and international standards.
Key Responsibilities
- Act as the primary responsible person for Logistica for logistics services pharmaceutical warehouses to the Egyptian Drug Authority (EDA).
- Formulate and implement updated regulatory affairs policies and procedures to maintain and enhance compliance.
- Develop and implement regulatory strategies and plans for the preparation and submission of new product dossiers.
- Establish regulatory priorities, manage budgets, and allocate resources effectively to meet departmental goals
- Monitor regulatory affairs trends that are related to environmental issues.
- Ensuring that a quality management system is implemented and maintained
- Ensuring that relevant regulatory customer complaints related to are dealt with effectively
- Comply with environmental management’s standards, objectives and trainings. Report immediately any environmental incidents.
- Manage the technical aspects of obtaining new pharmaceutical licenses.
- Prepare and submit product variation documents to the EDA.
- Oversee the disposal of expired medicines in strict adherence to EDA regulations.
- Serve as the primary point of contact with regulatory authorities during inspections, audits, and all compliance-related matters.
- Coordinate and attend EDA inspection visits at pharmaceutical warehouses alongside internal teams and clients.
- Build and sustain positive, professional relationships and a strong reputation with EDA personnel.
- Respond promptly and accurately to all letters and inquiries from the EDA.
- Develop, maintain, and update Standard Operating Procedures (SOPs) to ensure full compliance with EDA regulations.
- Ensure strict adherence to EDA Good Storage and Distribution Practices (GSDP) and other relevant quality standards.
- Review and approve critical technical documentation, including Certificates of Analysis (CoA).
- Verify that all product labelling, packaging, and promotional materials are in full alignment with data registered with the EDA.
- Monitor, interpret, and communicate the impact of changes in local and international regulations to the pharmaceutical warehouses.
- Follow up on product analysis with the EDA to secure final Certificates of Conformity.
- Conduct training sessions for various departments on new and updated EDA regulations.
- Ensure timely settlement of all EDA-related fees through consistent reconciliation with the finance team.
- Prepare detailed monthly fee reports for each client in coordination with the finance department.
Qualifications
- Qualifications & Experience
- Bachelor’s degree in pharmacy or science
- Minimum 7 Years of experience in the same field
- Experience dealing with regulatory authorities and audits.
- Fluent in writing & reading English.
Required Skills
- Attention to detail
- Time Management.
- Analytical skills
- Communication skills
- Project management
