תקציר
Novartis Israel is looking for a passionate Appointed Pharmacist to join the Regulatory inspired team.
About the Role
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 MoH & Novartis guidelines and in coordination with logistics & QA departments.
- Handing pruning/deregistration, temporary stock-out, information for Health Care Providers in accordance with MoH & 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 MoH 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
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
