Regulatory Affairs Associate, Gulf

Regulatory Affairs Associate, Gulf

Location: Cairo, Egypt

About the Position

Arcera, a global life sciences company headquartered in Abu Dhabi, is seeking a Regulatory Affairs Associate for the Gulf region. This role, based in Cairo, Egypt, will report directly to the Regulatory Affairs Lead, GULF. The position involves supporting all regulatory activities of assigned products within the Gulf region (UAE, Bahrain, Kuwait, Oman, and Qatar), ensuring compliance with local regulations and company policies.

Responsibilities

• Support the Regulatory Affairs Lead on all assigned regulatory activities within the Gulf.
• Keep up-to-date and archive all relevant regulations and regulatory guidelines.
• Manage the preparation, submission, and follow-up of all regulatory applications in the assigned region.
• Initiate the preparation and translation of proofread printed artwork ensuring compliance with the registered Product Information.
• Responsible for ordering and legalization of local CPP and other module 1 documents for local products.
• Perform regulatory due diligence on module 1 for all assigned products for the Gulf according to internal process/guidance.
• Ensure that the regulatory file is complete and available for dispatch to the distributor and timely submitted to the local Health Authorities.
• Work closely with Global RA on the submission strategy and the completion of the regulatory dossiers in line with local regulations.
• Coordinate the responses to requests by the authorities during the evaluation process and check the correct handling of deficiency letters within a specific timeframe.
• Create and maintain a full up-to-date database and archiving system for tracking the regulatory activities in the assigned region.
• Maintain the Regulatory databases: drug track and docubridge for local products.
• Adhere to Acino internal policies and standard operating procedures designed to ensure patient safety.
• Forward all received Product Quality Complaints, Adverse Events, and Medical Information Requests to the relevant person in Quality Assurance/Pharmacovigilance/Medical Affairs.
• Complete all trainings as per the training plan.

Requirements

• Bachelor’s degree in Pharmacy or a relevant field.
• 0 – 3 years of experience working in the Pharmaceutical industry in Regulatory Affairs.
• Extensive experience in preparation and submission of Regulatory files to local Competent Authorities in the region.
• Fluent level in English and Arabic both in oral and written communication.

We Are Arcera

At Arcera, we are united by our bold ambition to be a catalyst for change; proudly progressing the way the world heals, thrives, and evolves. We bring together the most advanced science, technology, and passionate people to innovate smarter health and wellbeing solutions, so patients can live longer, healthier lives.

At Arcera, you can:

• Drive meaningful change in healthcare and patient outcomes.
• Accelerate your career through mentorship and continuous development.
• Collaborate freely in a culture built on ownership, transparency, and work–life balance.
• Thrive and innovate in a dynamic, fast-growing environment, as One Arcera.

Arcera is an Equal Opportunity Employer.

How To Apply

Note that only direct applications via our HR system (follow the link above) will be considered.

Apply now