Regulatory Affairs Expert

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, have 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 Group of Pharmaceutical Companies employ a collective workforce of more than 1400 individuals & continue to expand their workforce with Talented Human Capital

Our Core Values:

· Diversity & Respect

· Integrity & Accountability

· Collaboration

· Leadership & Empowerment

· Innovation & Continuous Learning

Job Mission :

Successful job Holder will handle all related new registration/re-registration/variation files of Minapharm/MiGenTra products, ensuring compliance with Egyptian Drug Authority (EDA) guidelines to secure marketing authorizations. Key missions include preparing and submitting registration dossiers & handling renewals and variations.

Duties & Responsibilities :

Regulatory Affairs - Manufacturing Sector

• Plan EDA Visits and communicate with EDA inspector(S).

• Ensure compliance with regulations set by EDA.

• Prepare and submit all documents and reports requested by the EDA.

• Prepare requirement to be ready on time; from QC Department in the Preparation of COAs and reference standards needed to be submitted with finished products samples to center lab NODCAR(&or) Bio - inn

• Follow with validation department the submitting of the first three batches for any newly registered product.

• Follow Raw Materials upcoming RMs and their documents to facilitate EDA release process.

• Archive all the registration documents, EDA reports, samples & COAs for products submitted to NODCAR (&/OR) Bio-Inn.

• Follow all NODCAR (&/OR) Bio-Inn requirements for samples submitted to Central lab (EDA)

• Handle EDA audits.

• Prepare a complete file for each product to contain all documents sent by Registration department

• Perform any additional tasks as requested and review Master Files, Drawings, Files related to EDA requirements.

Qualifications (Educational Background & Preferred work Experience) :

-Not less than 6-9 years in relevant experience.

-Education Background : Bachelor’s degree in Pharmaceutical sciences is a must.

-Training: Training workshops held by EDA or external parties dealing with new/existing law or guidelines related to registration in Egypt.

- Functional / Technical Competencies : Strong Expertise in the following:

•Guidelines of registration process.

•Inspection/licensing procedures/ different registration ministerial decree/procedures of different registration submission (stability/pharmacology/naming/variation)

- Behavioral Competencies :

• Business Acumen

•Good Communication Skills

• Previous proven previous close interaction with Egyptian Drug Authority (EDA)

Additional Skills:

• Computer Skills Literacy (familiar with word/excel/PP).