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. The position is based in Dubai, UAE and will report directly to the Regulatory CMC Lead, META. This role will support the RA CMC Lead META and the RA Lead GEM on all regulatory activities within the assigned region. Collect and compile necessary raw documents, reports, justifications, declarations, and statements, to be included in the local Regulatory dossiers. Provide answer on quality question in deficiency letters from Health Authorities within any Regulatory procedures with local portfolio within the assigned region. Perform due diligence and advise Business development on quality sections of modules 2-3 of the Regulatory dossier before new local registration or acquisition within the assigned region. Maintain the regulatory archiving and tracking systems up dot date. Manage artwork and product information update. Your Responsibilities will be :

• Support the RA CMC Lead META and the RA Lead GEM on all regulatory activities.
• Write the Chemistry Manufacturing Control (CMC) part of Modules 2 and 3, compile modules 2, 3, 4 and 5 of the local Regulatory dossiers in CTD/eCTD format in English according to EU/local regulatory requirements, in cooperation with the local manufacturers, partners.
• Maintain life cycle of modules 2-5 of the Regulatory dossier for local portfolio in Docubridge system.
• Prepare, compile, and submit registration files for initial Marketing Authorisation Application (MAAs), variations, renewals and manufacturing site registrations, renewals etc.
• Coordinate the preparation of the submission files in cooperation with all stakeholders including the distributors.
• 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.
• Perform deep and accurate due diligence on quality sections of modules 2-3 in the local Regulatory dossiers within the META region according to internal process/guidance and according to EU/local regulatory requirements.
• Support the preparation and translation of proofread printed artwork ensuring compliance with the registered Product Information.
• Monitor and communicate new developments in regulatory legislation and guidelines.
• Manage the corresponding Business Partners and monitor all regulatory activities performed by them.
• Work closely with commercial and supply chain to ensure the continuity of supply during the submission of changes and no business interruption of the registered products in the country.
• 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.
• All training to be completed as per training plan.

Your Profile :

• Pharmacy, Pharmaceutical Sciences, or relevant discipline with at least 4 years professional experience in Regulatory Affairs and CMC in the Pharmaceutical industry.
• Experience in preparation and submission of Regulatory files to the Competent Authorities in the region.
• Fluent level in English in oral and written communication. Excellent communication skills also across cultures.
• Ability to maintain a structure documentation and archiving system.
• Ability to work under supervision, multi-task with attention to detail and manage multiple deadlines.
• Self-starter: ability to identify opportunities for improvement.
• High Ethics and Integrity: maintain an up-to-date and compliant archiving system
• Accountability for high quality Regulatory files and on time submissions.

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 \xe2\x80\x93 preferably via e-mail in one PDF document to the following email address: careers.dubai@acino.swiss We are looking forward to hearing from you. Only direct applications are considered.