Regulatory Affairs Specialist

About the role

Arcera, a global life sciences company headquartered in Abu Dhabi, develops, manufactures and commercialises medicines in more than 90 countries. It is looking for a Regulatory Affairs Specialist based in Cairo to handle regulatory submissions and compliance for Egypt.

Key responsibilities

• Complete low and medium complexity regulatory assignments and ensure they are done on time.
• Plan, prepare, compile and submit high-quality regulatory applications for Egypt, and prepare electronic submission files using tools such as DocuBridge.
• Track applications under regulatory review, update internal and external stakeholders, and maintain regulatory documentation and internal databases such as ARCERA.
• Review and approve artwork for product packaging materials in line with guidelines and standard operating procedures.
• Schedule and organise meetings with internal and external stakeholders, prepare meeting materials and take part in discussions.
• Communicate regulatory requirements to other departments, support project teams and attend internal trainings on time.
• Forward product quality complaints, adverse events and medical information requests to Quality Assurance, Pharmacovigilance and Medical Affairs.
• Maintain compliance with applicable legislation and support continuous improvement of regulatory processes.

Required profile

• Bachelor's degree in pharmacy, chemistry, biology or another life science.
• At least two years' experience in Regulatory Affairs; prior experience in a similar role is an advantage.
• Intermediate-level Business English.
• Strong understanding of regulatory requirements, processes, procedures and submission pathways, and in-depth knowledge of the regulatory life cycle of pharmaceutical products.
• Ability to work in cross-functional project teams and to communicate clearly and accurately.
• Adaptability and a proactive approach to challenging assignments.