Regulatory Affairs Specialist, Israel

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 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.

Requirements

Required education and experience  

• Bachelors degree in pharmacy or other life science degree (chemistry/biology)
• Previous experience of at least 2 years in regulatory affairs in Israel registration/renewal/variations of pharmaceutical products
• High standard of English.
• Extremely high standard of Hebrew.
• Proficient in Microsoft Office - Outlook, PPT, Word, Excel.

Required qualification

• Accurate.
• Ability to work under pressure.
• Energetic and hardworking.
• Trustworthy.