Regulatory Affairs Coordinator (Temporary)

Description:

Medison offers hope to patients suffering from rare and severe diseases, by forming partnerships with emerging biotech companies to accelerate access to highly innovative therapies in international markets.

As the creator and leader of the global partnership category in the pharma industry, we strive to be Always Ahead, and work relentlessly to bring therapy to patients in need, no matter where they live.

Our values are at the core of every action we take, and we are committed to going above and beyond for the benefit of the patients we serve.

We are a dynamic, fast-paced company, operating in over 25 countries on 5 continents. We are looking for out-of-the-box thinkers, people who are passionate, caring, agile and adaptive, to join us on our mission. If you are looking to make a difference in people's lives, we invite you to join us!

We are hiring a Temporary Regulatory Affairs Coordinator who will support the activities of the RA team, including but not limited to handling documents, placing orders with suppliers, managing packaging and office supply inventory, and performing general office tasks. The role also includes fulfilling additional assignments as requested by the direct manager.

• Preparing registration portfolios (new, renewal, and update) for submission to the MOH, and updating tracking charts for each product.
• Coordinating deliveries to the MOH and managing fee payments.
• Preparing packaging graphics in collaboration with the registration pharmacist, graphic designer, and manufacturer.
• Preparing user manuals for submission in accordance with MOH regulations, and coordinating review and approval with printing presses and manufacturers.
• Sending documents for translation and coordinating with translators and manufacturers; performing translation and proofreading in English.
• Ordering packaging materials and office supplies.
• Monitoring the validity of approvals for new and existing customers.
• Preparing regulatory submissions (new, renewal, and update) for the MOH.
• Preparing packaging artworks in collaboration with the registration pharmacist, graphic designer, and manufacturer.
• Preparing leaflets and artworks for submission in accordance with MOH regulations and coordinating further approvals with manufacturers.
• Tracking and updating RA activities in the SharePoint system and internal tracking tables.
• Printing letters and various pharmaceutical-related requests.
• Performing additional tasks as requested by the direct manager.

Required education and experience 

• Academic degree.
• Proficient in Microsoft Office – Word, Excel, PPT.
• Previous administrative experience.
• High level of English – reading and writing.

Required qualification

• Multitasking.
• Ability to learn quickly.
• Accurate.
• Service-oriented
• Pro-active, working well independently and in a team.