Regulatory Affairs Specialist

Regulatory Affairs Specialist
Category: Reg Affairs & Safety Pharmacovigilance
Location:

Kfar Saba, Israel, IL

Drive regulatory excellence in a region that matters, obtaining regulatory approvals and compliance for life-saving medicines and medical devices. Apply today!

Your new role

As a Regulatory Affairs Specialist, you'll be the regulatory backbone for Novo Nordisk's operations in Israel and the Palestinian Authority. You'll manage the full lifecycle of pharmaceutical product and medical device registrations—from initial submissions through renewals and new indications—ensuring seamless compliance with local regulations and internal standards.

Day-to-day your tasks will include:

Regulatory activities for obtaining and maintaining licenses for pharmaceutical products and medical devices, including NDA submissions, variations, renewals, and new indications
Preparing, reviewing and approving packaging materials in accordance with Ministry of Health requirements and Novo Nordisk SOPs
Supporting National Health Basket (NHB) submissions and ensuring timely, accurate documentation
Maintaining and updating Novo Nordisk internal regulatory affairs systems a
Reviewing and approving promotional materials according to Ministry of Health and Novo Nordisk guidelines
Participating in 29C procedures for importing non-registered products and leading relabelling projects
Collaborating cross-functionally with other departments to ensure regulatory continuity and consistency
Providing backup regulatory support to colleagues during periods of absence.

Your new department

As part of International Operations, you will join our largest operational unit. Covering 194 countries and 95% of the world's population, more than 18,000 of us work passionately to serve 35 million patients each day. With a promise to outperform the competition, we continue to be the growth driver for Novo Nordisk, and to improve health at scale across the globe.

Within International Operations, our team in Israel is dedicated to ensuring our innovative medicines and medical devices reach patients who need them. You'll be instrumental in navigating the local regulatory landscape, building relationships with the Ministry of Health, and maintaining Novo Nordisk's reputation as a trusted, compliant partner in the region.

Your skills & qualifications

We're looking for a Regulatory Affairs Specialist with deep expertise in the Israeli regulatory environment and a strong pharmaceutical background. You'll bring with you:

A bachelor’s or master’s degree in pharmacy A minimum of 2 years' experience in pharmaceutical product registration and regulatory affairs in Israel
Comprehensive knowledge of Israeli Ministry of Health regulations, procedures, and requirements
Strong experience with NDA submissions, product renewals, labelling updates, and packaging material compliance
Excellent attention to detail and ability to manage complex regulatory documentation
Fluent in Hebrew and English (written and verbal)
Excellent interpersonal skills, ability to work collaboratively in a team, and a supportive approach toward others
Strong organizational and project management skills with the ability to manage multiple registrations simultaneously
Collaborative mindset with proven ability to work effectively across departments and with external stakeholders.

Working at Novo Nordisk

Every day we seek the solutions that defeat serious chronic diseases. To do this, we approach our work with determination, constant curiosity and a commitment to finding better ways forward. For over 100 years, this dedication has driven us to build a company focused on lasting change for long-term health. One where diverse thinking, shared purpose and mutual respect come together to create extraordinary results. When you join us, you're not just starting a job – you're becoming part of a story that spans generations.

What we offer

Being part of a global healthcare company means opportunities to learn and develop are all around us. You'll work in a region where your expertise directly impacts patient access to innovative treatments, while our benefits are designed with your career and life stage in mind.

Deadline

March 15

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

At Novo Nordisk, we're not chasing quick fixes – we're creating lasting change for long-term health. For over 100 years, we've been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. This dedication fuels our constant curiosity and inspires us to push the boundaries of what's possible in healthcare. We embrace diverse perspectives, seek out bold ideas, and build partnerships rooted in shared purpose. Together, we're making healthcare more accessible, treating and preventing diseases, and pioneering solutions that create change spanning generations. When you join us, you become part of something bigger – a legacy of impact that reaches far beyond today.