Regulatory Affairs Specialist

Arcera is a global life sciences company headquartered in Abu Dhabi, United Arab Emirates. Our purpose is to enable longer and healthier lives while creating sustainable growth. We develop, manufacture, and commercialize a broad range of high-quality innovative and proven medicines in key international markets. With an operational footprint spanning over 90 countries across four continents, and manufacturing sites in eight countries, we offer more than 2,000 medicines across various therapeutic areas worldwide.

Main duties

• Completes low and medium complexity regulatory assignments and ensures timely execution of tasks.
• Plans, prepares, compiles, and submits high-quality regulatory applications for Egypt in compliance with applicable requirements, and prepares electronic submission files using document management tools such as DocuBridge.
• Tracks the status of applications under regulatory review, provides updates to internal and external stakeholders, and maintains regulatory documentation and internal databases such as ARCERA.
• Revises and approves artwork for product packaging materials in internal systems according to applicable guidelines and ensures adherence to regulatory compliance and standard operating procedures.
• Schedules and organizes meetings with internal and external stakeholders, prepares materials for these meetings, and actively participates in discussions.
• Communicates regulatory requirements to other departments, provides regulatory support to project teams and stakeholders, and attends internal trainings in due time.
• Forwards all received Product Quality Complaints, Adverse Events, and Medical Information Requests to the relevant teams in Quality Assurance, Pharmacovigilance, and Medical Affairs.
• Ensures compliance with applicable legislation, maintains internal regulatory information systems, and supports continuous improvement of regulatory processes.

Job Requirements

• Bachelor’s degree in pharmacy, chemistry, biology, or another life science.
• Minimum of two years’ experience in Regulatory Affairs within a relevant discipline; prior experience in a similar role is considered an advantage.
• Business English at least at intermediate level
• Strong understanding of regulatory requirements, processes, procedures, and submission pathways.
• In-depth knowledge of regulatory life cycle management for pharmaceutical products.
• Proven ability to collaborate effectively within cross-functional project teams.
• Demonstrates alignment with ARCERA principles and organizational values in all actions and decisions.
• Exhibits strong verbal and written communication skills, with a high level of accuracy and attention to detail.
• Possesses excellent interpersonal skills, with the ability to collaborate effectively across diverse functions, cultures, and organizational levels, including external business partners.
• Applies sound project management capabilities to plan, organize, and deliver tasks efficiently.
• Shows adaptability and a proactive mindset by embracing challenging assignments and pursuing opportunities that foster professional growth and capability development.

This is the opportunity to join a very dynamic organization, where decisions are taken fast and where you can actively participate in shaping our future. If this sounds exciting, we would love to hear more about you!