Regulatory Affairs Associate, Gulf

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.

This position is based in Cairo, Egypt and will report directly to the Regulatory Affairs Lead, GULF.  The role will be responsible to support the RA Lead on all regulatory activities of assigned products within the Gulf region (UAE, Bahrain, Kuwait, Oman and Qatar).  Ensure all Regulatory activities are conducted in compliance with local regulations and company policies and SOPs as well as support the Business through strong cross-functional collaboration.

Your Responsibilities will be:

Support the Regulatory Affairs Lead on all the assigned Regulatory activities within the Gulf.

Keep up-to-date and archive all relevant regulations and Regulatory guidelines (Regulatory Intelligence); inform Global RA on any changes/updates to the local requirements.

Manage the preparation, submission, and follow-up of all regulatory applications in the assigned region (variations, product renewals, site registration renewals, new registrations etc.).

Initiate the preparation and translation of proofread printed artwork ensuring compliance with the registered Product Information.

Responsible of 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 according to EU/local Region regulatory requirements.

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.

Co-ordinate 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, including mandatory attendance at pharmacovigilance training.

Forward all received Product Quality Complaints, Adverse Events and Medical Information Requests to the relevant person in Quality Assurance/ Pharmacovigilance/ Medical Affairs.

All trainings to be completed as per training plan.

Your Profile:

Education in Pharmacy, natural Sciences or relevant discipline.

Minimum of 5 years’ experience working in the Pharmaceutical industry in Regulatory Affairs and extensive experience in preparation and submission of Regulatory files to local Competent Authorities in the region.

Proven ability to effectively work collaboratively in cross functional teams.

Ability to work in a highly dynamic business environment.

Cross-cultural awareness and ability to work across geographical markets.

Multi-task ability and work well under pressure and tight deadlines.

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!