Country Regulatory Affairs Manager

Job Description

The Country Regulatory Affairs (Senior) Manager (cRAM) is responsible for selective Regulatory Affairs (RA) activities within the country RA department to support obtaining and maintaining marketing authorizations and ensure regulatory compliance at the country level.

The cRAM will also act as an Appointed Pharmacist on behalf of Sandoz Pharmaceuticals Israel Ltd. The Appointed Pharmacist will have advanced understanding of the Sandoz Portfolio, in depth knowledge of the assigned products, and local and global regulatory requirements.

Your Key Responsibilities

Your responsibilities include, but not limited to:

• Supports the roll-out of the RA department strategy in country and aligns with Regional and Global regulatory strategy (where relevant)
• Guarantees timely creation & translation of official product information including:Patient Information Leaflets, Summary of Product Characteristics (SmPCs) and all labelling (packaging texts into artworks) )
• Guarantees timely creation & translation of official product information including: outer packages, inner labels, blisters, local customization AWs materials, etc.
• Guarantees timely implementation of changes of the registered text into artworks. This can be either by overseeing or by performing the process tasks as per country-specific set-up: Perform text and Design review (manual proofreading and/or with support of electronical tools) and related documentation of created artworks according to GxP requirements.
• Ensure that all artworks are created as per the country specific requirements and the Sandoz brand expectations and implemented within the legal or internal timeframe.
• Perform the internal country responsibilities in the artwork process as described in the relevant SOPs.
• Strives to achieve the earliest acceptance of registration applications, launches, MA transfers, etc. .
• Provides regulatory support (general and product-specific) to the internal organization (e.g. Business Units, Portfolio & Launch, Medical, QA, PS)
• Plays an active role in the local launch team to achieve the company’s business objectives.
• Strives for efficient and simplified ways of working, and does this by identifying and implementing process improvement initiatives. Drive process optimization for activities under responsibilities.
• For the activities in scope of the role ensures that all relevant Key Performance Indicators (including safety label changes, CMC variations including product site transfers, artworks creation and updates, checklists, deviations, RA input in RMP implementation (review of educational materials) and DHPC communication), are achieved timely & correctly and that all GxP and RA relevant documents are archived as per specifications.
• Reviews of promotional materials in accordance with country regulation and Sandoz SOPs.
• Establishes and maintain effective relationship with IL-MOH, including strategic input for high level meetings on critical and / or strategic issues.
• Be the in-country SME on RA processes, tools, systems, and/or projects in scope of the role.
• Guarantee good and professional communication between internal and external stakeholders.
  
  

Essential Requirements

What you’ll bring to the role:

• University Degree in Pharmacy. Advanced degree is an advantage.
• Israeli Pharmacist license.
• Min 3-year experience as Appointed Pharmacist; experience in generics and biosimilars is an advantage.
• Fluent in Hebrew (native language) and English (full proficiency )
• Extensive experience in the pharmaceutical industry (>5y)
• Working in a highly regulated environment.
• Understanding and experience in risk management
• Understanding and experience with process optimization and SOP writing.
• Stakeholder management; Planning, organizational skills and eye for detail
• Accountability for actions, setting own priorities and decision taking
• Result oriented
  
  

You’ll Receive

Be part of a supportive and inclusive work environment that values your growth and contributions. Flexible working environment tailored to field-based roles, allowing you to manage your schedule effectively. Gain extensive learning and development opportunities, along with valuable scientific experience, within a dynamic multinational company.

Why Sandoz?

Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, touched the lives of almost 500 million patients last year and while we are proud of this achievement, we have an ambition to do more!

With investments in new development capabilities, state-of-the-art production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost, high-quality medicines, sustainably.

Our momentum and entrepreneurial spirit is powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills experience an agile and collegiate environment with impactful, flexible-hybrid careers, where diversity is welcomed and where personal growth is encouraged!

The future is ours to shape!

Commitment To Diversity & Inclusion

We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Join our Sandoz Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Sandoz and our career opportunities, join the Network here: Sandoz Talentpool (novartis.com)

#Sandoz