Regulatory Affairs Coordinator
About The Position
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 Regulatory Affairs Coordinator
Responsibilities
Administrative:
- Sending documents to be translated and working with translators and manufacturers. Translating and proofreading in English.
- Ordering packing supplies and office supplies.
- Monitoring the validity of approvals of new and existing customers.
- Printing letters and various pharmaceutical requests.
- Fulfilling other tasks requested by direct manager.
QP and RP support:
- Preparing and sending import requests in the “Maslul” system (MOH Portal)
- Requests for yearly import approvals and updating approved requests.
- Batches: preparing documents for batch release, sending batch certificates, populating released batch information in the QP chart, preparing batch portfolios.
RA support:
- Preparing registration portfolios (renew and update) to send to MOH.
- Preparing the graphics for packaging - working with registration pharmacist, graphic designer, and manufacturer.
- Preparing leaflets and artworks for submission according to the regulations of MOH and further approvals with the manufacturers
Requirements
- Academic degree.
- Proficient in Microsoft Office – Word, Excel, PPT.
- Previous administrative experience.
- High level of English – reading, writing and talking.