לוח משרות דרושים ביוטכנולוגיה

We offer 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 30 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 want to make a difference in people's lives, we invite you to join us! The Regulatory Affairs Specialist works in the pharmacy division. Preparation of registration portfolios - including checking that contents are according to regulations, writing consumer manuals, designing packaging, attending to changes/renewal/updates including stringencies with manuals, and supporting all activities in the pharmacy division.
Responsibilities:
Field of responsibility
* Preparation of all types of submissions -products, renewals, variations, leaflets and packaging.
* Responsibility for maintaining up-to-date product regulatory dossier.
* Direct contact with the Ministry of Health and partners abroad.
* Conducting regulatory and document checks.
City:
Petah Tikva

Responsibilities
Support the maintenance and organization of the Design History File (DHF) documentation.
Assist in completing documentation required for product releases in compliance with FDA, CE, ISO, and internal procedures.
Provide administrative support for design control activities throughout the product development lifecycle.
Support documentation related to software validation and traceability.
Assist in preparing documentation for audits and regulatory submissions.
Ensure documentation is accurate, complete, and properly filed in internal systems.