Regulatory Affairs Coordinator

Phibro seeking a RA Coordinator, for our Beit Shemesh site in Israel. Hybrid work: one day a week from home

Responsibilities: 

•    Update and maintain databases to ensure information is accurate, renewal dates are known and planned, and information is readily communicated to all interested parties.

•    Archive in accurate and timely manner the regulatory documents.

•    Update regulatory documentation following issue of licenses. 

•    Prepare the Quarterly regulatory activities report. 

•    Ensure national requirements are up to date and communicated to global regulatory affairs.

•    In this Position, the Regulatory Affairs coordinator will coordinate the Artwork activities, 

•    Plan and execute artwork change and align with manufacturing production schedules to maximize impact of new packaging introduction and minimize packaging write off costs. Ensure artwork changes following license renewals and variations are made in line with published timelines. Maintain adequate processes to ensure monitoring of artwork changes.

Requirements:

•    Bachelor’s degree Biology, Chemistry, or other equivalent qualifications

•    Necessary: very high level of English; additional languages – strong advantage.

•    1-2 years Regulatory Affairs experience in the pharmaceutical industry – Preferred 

Or administrative experience in English / or background in QA from industry or R&D.

•    Able to use standard business software, communication tools and documents management systems. A first experience with RIM systems, VEEVA, is preferred. 

•    Graphic design knowledge would be ideal. 

•    Analytically minded with strong attention to detail and problem-solving skills

•    Experience in building an international relationship across geographically, time zones and different cultures.