דרושים » רפואה ופארמה » מנהל /ת רגולציה גלובלית לחברת מכשור רפואית איכותית במרכז

We are looking for out-of-the-box thinkers, people who are passionate, caring, agile and adaptive, to join us on our mission. If you are looking to make a difference in people's lives, we invite you to join us! Reporting to the Chief Operating Officer, the Director of Tech Ops, Israel will be a key member of the Israel Leadership Team. The Director will also be a member of the Global Tech Ops Leadership Team, contributing to global strategic discussions and initiatives. This role is responsible for setting the strategic direction and overseeing execution across Supply Chain, Quality Assurance, Regulatory Affairs, and Pharmacovigilance for both development programs and licensed products in the Israeli market. The Director will serve as a senior advisor to management on operational and compliance risks and will represent the company in interactions with regulatory authorities. This is a hybrid role that combines high-level strategic planning with hands-on operational leadership, supporting a growing pipeline and dynamic business environment.
Responsibilities:
Strategic & Functional Leadership:
* Lead the IL Tech Ops team across all operational domains
* Lead a large organization (~100 people), Including direct management of managers
* Define and execute strategy aligned with global and regional objectives
* Oversee planning, budgeting, and resource allocation
Quality & Regulatory:
* Ensure compliance with GMP, GDP, MPLO and global standards
* Lead the Quality Management system (QMS), including audits and management reviews
* Oversee regulatory submissions and lifecycle management
Supply Chain & Commercial Interface:
* Manage logistics, warehousing, and distribution operations
* Partner with Commercial and Finance on demand planning, launches, and inventory
* Ensure supplier qualification and contract compliance
Cross-Functional Collaboration:
* Act as a key liaison with regional leadership
* Align operations with business development and product lifecycle needs
* Drive global project execution
* Foster a culture of accountability, transparency, and continuous improvement
City:
Petah Tikva

At our company, we empower businesses to thrive in todays fast-paced world. As a Platform licensing Program Manager, you will oversee large, cross-functional licensing programs that have a direct impact on our companys long-term business success. Your focus will be on program ownership, strategic alignment, and process governance across multiple teams and domains. 
This role requires exceptional leadership to drive cross-functional collaboration, influence decision-making at all levels, and foster a culture of accountability and innovation. Strong stakeholder management skills are essential for aligning diverse teams, balancing competing priorities, and ensuring smooth execution of large-scale licensing initiatives. Additionally, analytical skills are critical for identifying trends, assessing risks, and leveraging data-driven insights to inform strategic decision-making, anticipate challenges, and proactively solve problems before they impact program success.
What youll do:
This role provides a unique opportunity to be a part of our licensing strategic programs, collaborate with cross-company stakeholders, enhance transparency, and optimize delivery outcomes while ensuring regulatory compliance and adherence to timelines. As such, this role will focus on:
Licensing Program Ownership: Lead end-to-end planning and execution of strategic licensing programs that span multiple teams and domains.
Stakeholder Coordination: Ensure cross-functional teams (Legal, Compliance, GTM, Product, R&D, Finance, etc.) are aligned and working towards shared objectives. 
Risk & Dependency Management:  Identify and mitigate cross-company alongside external regulatory risks, constraints, and dependencies to prevent execution bottlenecks and ensure smooth progress.
Process & Governance: Maintain governance structures, reporting mechanisms, and tracking frameworks to ensure visibility across all stakeholders levels including executive management.
Strategic Impact: Ensure that licensing programs adhere to regulatory expectations while maintaining a high level of execution excellence. Drive measurable outcomes that significantly contribute to business growth and product scalability.

offers hope to patients suffering from rare and severe diseases by forming partnerships with emerging biotech companies to accelerate access to highly innovative therapies in international markets.
As the creator and leader of the global partnership category in the pharma industry, we strive to be Always Ahead, and work relentlessly to bring therapy to patients in need, no matter where they live.
Our values are at the core of every action we take, and we are committed to going above and beyond for the benefit of the patients we serve.

We are a dynamic, fast-paced company, operating in over 25 countries on 5 continents. We are looking for out-of-the-box thinkers, people who are passionate, caring, agile and adaptive, to join us on our mission. If you are looking to make a difference in people's lives, we invite you to join us!
As a QP Pharmacist, you will be Responsible for ensuring compliance with all ongoing control processes designed to guarantee that products are not released to the market until it is determined that their quality matches the approved specifications in the registration file.

In addition, responsible for quality processes in the regulatory affairs department that will be adapted to international standards, local regulations, where applicable, and the organizational quality level established for medical products.

This is a temporary position for 8 months.
Responsibilities
Qualified Person Responsible Pharmacist of the importer.
Ensuring Compliance with Israeli Regulations: The QP is responsible for ensuring that all pharmaceutical products meet the standards set forth by Israel's Ministry of Health (MoH) and other relevant regulatory authorities. Review the product batch release documentation and authorizing or rejecting the batch release to the market. Certification of Compliance: to certify that each batch of the product has been produced and tested according to relevant specifications and regulations before it reaches the market.
Accompanying regulatory audits and being responsible for regulatory knowledge, document control, writing procedures, maintaining and updating relevant professional literature, and assisting in planning training activities in the field.
Liaison with the MOH and working according to the MOH guidelines, including immediate reporting of any complaint or recall if necessary.
Responsible for batch releases of registered and non-registered products.
Review PQRs and full batch records provided by the partners.
Execution of additional supervisors instructions and tasks accordingly.