Regulatory Affairs Specialist

Company Description

BYC provides solutions for a variety of startups and growing companies.

One of our Clients is a Medical company.

Role Description

This role includes full responsibility for managing regulatory registration processes for pharmaceuticals, dietary supplements, and medical devices with health authorities

You’ll be preparing registration files, monitoring status, and ensuring compliance with regulatory requirements

You’ll also be writing and updating package inserts, labels, and product documentation, as well as supporting the launch of new products or changes to existing ones

Part of the role includes tracking regulatory changes and updating internal policies accordingly

Requirements include a valid Israeli pharmacist license – this is an absolute must

You should have at least 4–5 years of experience in drug registration, including submissions, renewals, and variations according to Israeli law

Experience in pharmacovigilance is required, including handling adverse events, updating patient and physician leaflets, and submitting PSURs

Experience in medical device registration is a strong advantage

Good English is essential

We’re looking for someone detail-oriented, independent, highly organized, with strong interpersonal and teamwork skills