October 10, 2024

Medison Pharma

פתח תקווה

Regulatory Affairs Associate

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 Associate

Requirements:

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

Responsibilities:

Preparing registration portfolios (renew and update) to send to MOH. Update charts where each product is tracked.
Coordinate deliveries to MOH and paying fees.
Preparing the graphics for packaging - working with registration pharmacist, graphic designer, and manufacturer.
Preparing user manuals to submit according to the regulations of MOH, check and approve manuals with printing press and manufacturers.
Sending documents to be translated and working with translators and manufacturers. Translating and proofreading in English.
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.
Ordering packing supplies and office supplies.
Monitoring the validity of approvals of new and existing customers.
Receiving temperature approvals from manufacturers.
Printing letters and various pharmaceutical requests.
Office work and travel coordination.
Fulfilling other tasks requested by direct manager.