Regulatory Affairs Specialist

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:

Responsible for the preparation of product inserts & CTDs. Verify Promotional Materials and information leaflets to ensure the medical & scientific accuracy of the data. conduct medical trainings to the field force.

Responsibilities:

1. Prepare, review and update product inserts.
2. Prepare products CTDs. (Modules 4 & 5 and related module 2).
3. Review and verify promotional materials and information leaflets to ensure the medical and scientific accuracy of the data.
4. Conduct medical trainings to the medical representatives.
5. Respond to and follow up on medical trainings.
6. Liaise with the Egyptian Drug Authority as the representative of Minapharm for export regulatory tasks.
7. Ensure the completion of modules for each file in accordance with the regulatory guidelines of respective countries.
8. Prepare the company registration files for new markets as well as renewals of company registration in current ones, following different countries guidelines.
9. Assist in keeping the company informed of updated regulatory requirements in international markets.
10. Perform regulatory review of labeling design and specification changes required by foreign regulatory affairs, according to different countries guidelines.

Job Requirements:

Bachelor's degree of medicine, Pharmacy or clinical Pharmacy degree.

Experience : 1-3 years of experience.

Advance knowledge of English Langue.

Advanced Knowledge of CTD Preparation

Advance knowledge of company's related disease Areas

Good Luck to All!