Compliance Testing Manager responsible for independent compliance testing and validation within TD Bank's U.S. Compliance Monitoring and Testing Team. Leading and planning engagements to ensure regulatory compliance and operational effectiveness.
About the role
- Regulatory Affairs Specialist managing the lifecycle of pharmaceutical registrations at Novo Nordisk in Israel. Driving compliance for life-saving medicines and medical devices throughout the regulatory process.
Responsibilities
- Drive regulatory excellence in a region that matters, obtaining regulatory approvals and compliance for life-saving medicines and medical devices.
- 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.
Requirements
- 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.
Benefits
- 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.
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