Regulatory Affairs Associate, CMC – META
Dubai UAE, 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 position is for a limited period of one year, based in Dubai, UAE and will report directly to the Regulatory Affairs Director – META. The role will be responsible for all assigned Regulatory activities within META including regulatory due diligence within the assigned region. Additionally will also write and maintain all CMC sections of the regulatory files for local manufacturing within the assigned region.
Your Responsibilities will be :
- Support the Regulatory Affairs Manager in the assigned Regulatory activities.
- Prepare and compile registration files for submission of initial Marketing Authorization Application (MAAs), variations, renewals and manufacturing site registrations/renewals.
- Coordinate the writing and submission of files in cooperation with the local manufacturers and distributors.
- Compile and write the CMC part of Modules 2 and 3 Dossier in CTD format in English according to EU/local regulatory requirements.
- Collect and compile necessary raw data, documents and samples (active substance, impurities, finished product) to be included in the regulatory file.
- Update and maintain all CMC sections of the local files in validated systems
- Support the preparation and translation of proofread printed artwork ensuring compliance with the registered Product Information.
- Prepare responses to requests by the authorities during the evaluation process, and correct handling of deficiency letters within a specific time frame.
- Create and maintain a full up-to-date database and archiving system for tracking the regulatory activities in the region.
- Perform and document regulatory due diligence on all assigned products within the META region according to internal process and guidance.
Your Profile :
- Pharmacy Graduate, natural Sciences or relevant discipline.
- Minimum of 3 years professional experience in Regulatory Affairs in pharmaceutical industry (in Research and Development, Quality Assurance, Quality Control departments).
- Good understanding of analytical methods for quality control of medicinal products, validation of analytical procedures and validation of technological process, procedures of bio equivalence / clinical trials/ biowaver.
- Experience in writing and compiling CMC sections of Regulatory files in collaboration with local manufacturers
- Fluent level in English both in oral and written communication; Arabic is an asset.
- Ability to maintain a structure documentation and archiving system.
- Self motivated, ability to work under supervision, multi-task with attention to detail and manage multiple deadlines.
Please submit your direct application via this LINK
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:
We are looking forward to hearing from you. Only direct applications are considered.Job list