Regulatory Affairs Associate, GEM

Cairo, Egypt, Middle East, Turkey, and Africa

Acino is a Swiss pharmaceutical company, leader in advanced drug delivery
technologies. We have a clear focus on selected emerging markets in the Middle
East, Africa, the CIS Region and Latin America, and operate in some of the
most dynamic countries of the world. We value courage, commitment, trust and
empathy and provide an environment that supports initiative and effort. We are
proud to be action-oriented and open-minded, with a strong focus on quality
and product availability, even in remote and hard to reach areas of the world.
This role will be based in Cairo, Egypt and will report to the
Regulatory Affairs Lead, GEM. The role will be responsible for supporting
the RA Lead on all regulatory activities of assigned products within the Gulf
and Eastern Mediterranean (GEM) region (UAE, Bahrain, Kuwait, Oman, Qatar, and
Jordan), maintaining the regulatory archiving and tracking systems up to date
and managing artwork and product information update.
Your responsibilities will be :
* Support the Regulatory Affairs Lead on the assigned Regulatory activities.
* Prepare and compile registration files for submission of initial Marketing Authorization Application (MAAs), variations, renewals and manufacturing site.
* registrations/renewals etc.
* Coordinate the preparation of the submission files in cooperation with the Regulatory Affairs Lead, Global RA and the distributors.
* Review all relevant data and documents from the different departments and/or third parties involved for eligibility (contents) and consistency throughout the regulatory file.
* Collect and compile necessary data, documents and samples (active substance, impurities, finished product) to be included in the regulatory file.
* Prepare responses to requests by the authorities during the evaluation process, and correct handling of deficiency letters within a specific timeframe.
* Support the preparation and translation of proofread printed artwork ensuring compliance with the registered Product Information.
* Monitor new developments in regulatory legislation and guidelines.
* Create and maintain a full up-to-date database and archiving system for tracking the regulatory activities in the region.
* 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.
* Make sure all trainings are completed as per the training plan.
Your Profile :
* Bachelor's degree in pharmacy, pharmaceutical sciences, or relevant discipline.
* Minimum ‎3 years of experience in Regulatory Affairs within the Pharmaceutical industry and ‎1 year in a similar position.
* Experience in preparation and submission of Regulatory files to the Competent Authorities in GEM.
* Ability to maintain a structured documentation and archiving system.
* Self-organization, attention to details, prompt and accurate performance of tasks and responsibilities.
* Fluent written and spoken English. French is a plus.
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!
Please note only direct applications via our HR system will be considered.

Further Information

If you are interested in working for a company that offers such challenging
opportunities, we invite you to send your application along with all pertinent
documents - preferably via e-mail in one PDF document to the following email
address:
[email protected]
We are looking forward to hearing from you. Only direct applications are
considered.