Description

Job Description

Importation Regulatory Affairs Specialist / Sr. Specialist

Minapharm Pharmaceuticals is a leading pharmaceutical company in Egypt and the Middle East and the largest end-to-end manufacturer of biological therapies in MEA with over 20 years of experience in cellular and bioprocess engineering.

Headquartered in Cairo, Minapharm commercializes over 100 life-saving and life-enhancing products ranging from small molecules to complex bioengineered proteins and viral vectors, with an impressive immunotherapy pipeline.

Together with its wholly-owned Berlin-based subsidiary, ProBioGen AG – a world-leading CDMO, Minapharm has established an integrated business model making it the only gene-to-market company in the region.

Consolidating its international platform of intelligent biopharmaceutical technologies with the longstanding process development and manufacturing expertise in the MEA, Minapharm, together with ProBioGen, has incorporated MiGenTra GmbH headquartered in Berlin and manufacturing in Cairo, to enhance the accessibility to critical healthcare transforming medicines through product development and commercialization of Biosimilar mABs, Cell, and Gene Therapies and vaccines, at affordable prices in Egypt, and MEA.

Minapharm employs a collective workforce of over than 1400 individuals & continues to expand their workforce with talented pool of Human Capital.

Our Core Values:

• Diversity & Respect
• Integrity & Accountability
• Collaboration
• Leadership & Empowerment
• Innovation & Continuous Learning

Job Mission

Responsible for preparing & submitting shipping documents based on EDA regulations & any health authorities as per the case to get customs release approval.

Duties & Responsibilities:

1. Communicate with EDA regarding pre-submission strategies & clearance of the imported goods.
2. Share EDA requirements with the concerned departments to get EDA release for any consignments smoothly.
3. Preparation of EDA documentation for submitted files & fulfilling EDA requirements.
4. Submission of all invoices that needs EDA approvals either for getting customs release approval for the consignments at port or export approval for samples as well.
5. Responsible for hand over EDA approvals to logistics operators & notify the concerned departments by released consignments & its documents.
6. Calculate medical stamp.
7. Communicate with supply chain & relevant departments regarding any EDA obstacles or updated requirements to clear all pending consignments at the port.
8. Review ISO & GMP certificates renewal.
9. Entering EDA data on oracle for all shipments.
10. Prepare & submit of all documents for getting veterinary approval for shipments.
11. Ensure adherence to standard operating procedures/ work instructions for EDA customs clearance approval.

Qualifications (Educational Background & Preferred work experience):

• Bachelor’s degree in pharmacy or science.
• Not less than 1-2 years of experience in regulatory affair importation approval & customs release.
• Knowledge:

-Basics regulations for importation & customs release procedures.

-Computer Literate.

-English Proficiency.

-Problem solving skills.