Location: Hybrid (Office and home office)

Novartis Israel is looking for a passionate Appointed Pharmacist to join the Regulatory inspired team.

Your Key Responsibilities:
Your responsibilities include, but not limited to:

• Ensure rapid submission and approvals of new products, dosage forms and additional indications according to agreed objectives.
• On time maintenance activity: renewal of licenses and variations – including labeling updates, CMC changes, site transfers, artworks in accordance with Mo H & Novartis guidelines and in coordination with logistics & QA departments.
• Handing pruning/deregistration, temporary stock-out, information for Health Care Providers in accordance with Mo H & Novartis guidelines and in coordination with other functions as necessary.
• Review promotional materials and materials for the general public or patients correct and or suggest alternatives in accordance with local regulations and Novartis standards. Submit to Mo H according to local regulations and per professional judgement.
• Coordinate and ensure quality and fast responses to Health Authority questions, and relevant functions within Novartis.
• Ensure accurate and timely input on submissions & approvals, and launches dates for the portfolio.
• Support QA & logistics dept. with related issues (temporary stock-out, storage requirements, 1st batch etc.).
• For products under the responsibility of RA associate (not an appointed pharmacist) - coach the associate on the processes, thoroughly review the files, correct as required and monitor.

Essential Requirements:

• Understanding of the Pharmaceutical industry, economic drivers of the business, legal framework.
• At least 2 years of experience in Regulatory Affairs from Pharma.
• Education: Pharmacist
• Proficient Hebrew and English, both written and spoken.
• Experience in interacting with the Ministry of Health.
• Innovative thinking.
• Project Management.
• Digital Savvy.

Desirable Requirements:

• Prior experience as Appointed Pharmacist.
• Experience with labeling changes.

Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture

Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network

Commitment to Diversity and Inclusion / EEO:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network
Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards

Development

Innovative Medicines

Israel

Israel

IL04 (FCRS = IL004) Novartis Israel

Research & Development

Full time

Regular

No