Regulatory Affairs Vacancy At Minapharm Pharmaceuticals
Position: Export Regulatory Affairs Specialist / Senior Specialist
About the job
About Minapharm:
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.
Our Values:
Diversity & Respect
Integrity & Accountability
Collaboration
Leadership & Empowerment
Innovation & Continuous Learning
Job Summary:
To achieve registration plan of Minapharm’s pharma/biopharma products in different export markets. The responsibility is to prepare CTD &eCTD files and documents required for Minapharm sites and products registration in all Ex-Egypt countries through direct contact with EDA in addition to regulatory agents in different countries.
Duties & Responsibilities:
1.Deal with Egyptian Drug Authority as Minapharm representative in export regulatory tasks.
2. Request, follow up and review all data needed for preparing CTD files from all departments (QA, QC, validation, R&D … ) according to different countries guidelines.
3. Request and review all studies needed for preparation of registration files (stability study, clinical& non clinical studies) according to different countries guidelines.
4. Request documents from planning department concerning to APIs & Excipients for each registration file (DMF, CEP, LOA, COA, MSDS, GMP) according to different countries guidelines.
5. Prepare CTD & e-CTD dossiers for registration and re-registration according to different countries guidelines.
6. Prepare the company registration files for new markets as well as renewal of company registration in t he current ones according to different countries guidelines.
7. Request samples for analysis with registration files according to different countries guidelines.
8. Follow up with our agent s in different countries for any inquiry according to different countries guidelines.
9. Assist in keeping company informed of updated regulatory requirements in the International markets.
10. Perform regulatory review of labeling design and specification change required by abroad regulatory affairs according to different countries guidelines.
11. Perform any additional t asks if requested.
Qualifications:
Experience:
• Specialist: 0-3 years’ experience in the same position in pharmaceutical industry.
• Senior Specialist: Specialist: 3-6 years’ experience in the same position in pharmaceutical industry. Education:
• Bachelor degree in Pharmaceutical Science.
Knowledge:
• Basic knowledge of CTD& e CTD dossier preparation and submission.
• Basic knowledge of international and regional regulatory guidelines.