Regulatory Affairs Sr. Manager

Job Objective:

Regulatory Affairs Senior Manager is the responsible for any communication and coordination with EDA , European Medicines Agency (EMA) and/or other International Health Authorities (as required).

Liaison and support between regulatory bodies and operating divisions of the company. Responsible for reviewing and managing the regulatory function by ensuring compliance with (EDA), European Medicines Agency (EMA) and other International Health Authorities (as required), regulations and guidelines to obtain and maintain the corresponding approvals for any GMP area, including Plasma Supply Chain, Manufacturing facility, Exportation / Importation for plasma and/or Final Product in Egyptian Market or others (as required).

Key responsibility:

• Communication with local and international Health Authorities. Support, communication and coordination (as necessary) with local Health Authorities for Plasma Supply chain and Manufacturing facilities for the process of licensing, certification, exportation, importation, and finished product release.
• Ensure that applicable Health Authorities guidelines, rules and regulations are applied up to date, covering plasma or finished products or GMP sites and regulatory processes.
• Review and manage the licensing and GMP certification regulatory process for Plasma supply chain and manufacturing. Ensure any submissions related to local and international Health Authority are performed on time for initial licensing and renewal (if applicable) to maintain valid license and/ or certification is maintained in all facilities per existing regulations.
• Review all the documentations prepared to be submitted to EDA , International Health Authorities and any Certification entities.
• Change notification to Local and International Health Authorities.
• Change notification and customers related to Change Control implementation.
• To assist Direct Manager in any assigned duties.
• Manage Regulatory Affairs Area to ensure compliance with the above-mentioned points.
  
  
  

Academic & Professional Experience Required

• Bachelor s Degree in Health-related Sciences, preferably pharmaceutical area.
• Post-Graduate Certification in Quality Management.
• Knowledge of cGMP requirements preferred.
• Minimum of 4 years of Management or technical leadership experience is required.
• Minimum of 8 years of related experience in Regulatory Affairs field, including Pharma
• Manufacturing background, and Final Product importation and exportation experience.
• Preferably with experience on EMA Regulatory requirements and submissions.